natgillin/translations-raw huggingface dataset:
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
Pred začetkom uporabe zdravila Elebrato Ellipta se posvetujte z zdravnikom: - če imate astmo (zdravila Elebrato Ellipta ne uporabljajte za zdravljenje astme), - če imate težave s srcem ali visok krvni tlak, - če imate težave z jetri, - če imate pljučno tuberkulozo (TB) ali kakšne dolgotrajne ali nezdravljene okužbe,
The effect of fluticasone furoate/umeclidinium/vilanterol on the QT interval has not been evaluated in a thorough QT (TQT) study.
Srčna elektrofiziologija Učinka kombinacije flutikazonfuroat/umeklidinij/vilanterol na interval QT niso ocenili v podrobni študiji QT
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).
Študija IMPACT (CTT116855) je bila 52 tednov trajajoča študija (N = 10355), v kateri so primerjali zdravilo Elebrato Ellipta (92/55/22 mikrogramov) s kombinacijo flutikazonfuroat/vilanterol 92/22 (FF/VI) in s kombinacijo umeklidinij/vilanterol 55/22 mikrogramov (UMEC/VI).
Following repeat dosing of inhaled fluticasone furoate /vilanterol, steady state was achieved within 6 days with up to 1.6-fold accumulation.
Po večkratnem odmerjanju inhalirane kombinacije flutikazonfuroat/vilanterol je bilo stanje dinamičnega ravnovesja doseženo v 6 dneh; kopičenje je bilo do 1,6-kratno.
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.
V študiji FULFIL je zdravilo Elebrato Ellipta na podlagi podatkov do 24 tednov značilno zmanjšalo (p = 0,002) letni delež zmernih ali hudih poslabšanj za 35 % (95 % IZ: 14, 51) v primerjavi z BUD/FOR.
Co-administration of Elebrato Ellipta with other long-acting muscarinic antagonists or long-acting beta2adrenergic agonists has not been studied and is not recommended as it may potentiate the adverse reactions (see section 4.8 and section 4.9).
Druge dolgodelujoče antimuskarinske učinkovine in dolgodelujoči agonisti adrenergičnih receptorjev beta2 Sočasna uporaba zdravila Elebrato Ellipta z drugimi dolgodelujočimi muskarinskimi antagonisti ali dolgodelujočimi agonisti adrenergičnih receptorjev beta2 ni raziskana in ni priporočljiva, ker lahko poveča neželene učinke (glejte poglavji 4.8 in 4.9).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (SINGLE PACKS)
ZUNANJA OVOJNINA (SAMO POSAMIČNA PAKIRANJA)
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).
V študiji FULFIL je zdravilo Elebrato Ellipta med 1. in 24. tednom značilno bolj zmanjšalo (p < 0,001) uporabo rešilnega zdravila kot BUD/FOR (razlika med zdravljenjema: -0,2 dogodka na dan; 95 % IZ: -0,3,
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.
Študija FULFIL (CTT116853) je bila 24 tednov trajajoča študija (N = 1810) s podaljšanjem do 52 tednov v podskupini preiskovancev (n = 430), v kateri so primerjali zdravilo Elebrato Ellipta (92/55/22 mikrogramov) s kombinacijo budezonid/formoterol 400/12 mikrogramov (BUD/FOR) dvakrat na dan.
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).
V študiji FULFIL je zdravilo Elebrato Ellipta značilno zmanjšalo tveganje za zmerno ali hudo poslabšanje v primerjavi z BUD/FOR v 24 tednih (33 %; 95 % IZ: 12, 48; p = 0,004).
How to store Elebrato Ellipta 6.
Shranjevanje zdravila Elebrato Ellipta 6.
There is no specific treatment for an overdose with Elebrato Ellipta.
Za preveliko odmerjanje zdravila Elebrato Ellipta ni specifičnega zdravljenja.
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1237/001
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/17/1237/001
2 years Shelf-life after opening the tray: 6 weeks
Rok uporabnosti po prvem odprtju embalaže: 6 tednov.
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.
Študija 200812 je bila 24 tednov trajajoča študija neinferiornosti (N = 1055), v kateri so primerjali zdravilo Elebrato Ellipta (92/55/22 mikrogramov) s sočasno uporabljeno kombinacijo FF/VI (92/22 mikrogramov) + UMEC (55 mikrogramov) enkrat na dan kot zdravljenje z več inhalatorji pri bolnikih z anamnezo zmernih ali hudih poslabšanj v 12 mesecih pred vstopom v študijo.
Elebrato Ellipta should be used with caution in patients with moderate to severe hepatic impairment (see sections 4.4 and 5.2).
Pri bolnikih z zmerno do hudo okvaro jeter je treba zdravilo Elebrato Ellipta uporabljati previdno (glejte poglavji 4.4 in 5.2).
If you are breast-feeding, you must check with your doctor before you use Elebrato Ellipta.
Če dojite, se morate pred uporabo zdravila Elebrato Ellipta posvetovati z zdravnikom.
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).
V 52-tedenski študiji na skupno 10355 bolnikih s KOPB z anamnezo zmernih ali hudih poslabšanj v 12 mesecih pred vstopom v študijo (povprečni presejalni FEV1 po bronhodilatatorju 46 % predvidenega, standardni odklon (SD) 15 %) (študija CTT116855) je bila pojavnost pljučnice v skupini z zdravilom Elebrato Ellipta (n = 4151) 8 % (317 bolnikov), v skupini s kombinacijo flutikazonfuroat/vilanterol (n = 4134) 7 % (292 preiskovancev) in v skupini s kombinacijo umeklidinij/vilanterol (n = 2070) 5 % (97 preiskovancev).
The European Medicines Agency has waived the obligation to submit the results of studies with Elebrato Ellipta in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Ellipta za vse podskupine pediatrične populacije pri KOPB (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
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).
V študiji IMPACT je zdravilo Elebrato Ellipta v 52 tednih značilno zmanjšalo (p < 0,001) letni delež zmernih ali hudih poslabšanj za 15 % (95 % IZ: 10, 20) v primerjavi s FF/VI (delež; 0,91 v primerjavi z 1,07 dogodkov na bolnik-leto) in za 25 % (95 % IZ: 19, 30) v primerjavi z UMEC/VI (delež; 0,91 v primerjavi z 1,21 dogodkov na bolnik-leto).
No clinically relevant effects of hypokalaemia were observed in clinical studies with Elebrato Ellipta at the recommended therapeutic dose.
V kliničnih študijah zdravila Elebrato Ellipta med uporabo priporočenih terapevtskih odmerkov niso opažali klinično pomembnih učinkov hipokaliemije.
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%).
predvidenega, standardni odklon (SD) 13 %), od katerih jih je 65 % imelo zmerno/hudo poslabšanje KOPB v letu pred vstopom v študijo (študija CTT116853), so do 24. tedna ugotovili večjo pojavnost pljučnic med prejemniki zdravila Elebrato Ellipta (20 bolnikov, 2 %) kot med prejemniki kombinacije budezonid/formoterol (7 bolnikov, < 1 %).
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).
Delež odzivnih bolnikov je bil med 21. in 24. tednom značilno večji (p < 0,001) pri zdravljenih z zdravilom Elebrato Ellipta v primerjavi z BUD/FOR (47 % v primerjavi s 37 %; RO 1,59; 95 % IZ: 1,30, 1,94).
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).
Tudi v študiji IMPACT je bil delež odzivnih bolnikov značilno večji (p < 0,001) pri zdravilu Elebrato Ellipta (36 %) v primerjavi s FF/VI (29 %; RO 1,36; 95 % IZ: 1,19, 1,55) in UMEC/VI (30 %; OR 1,33; 95 % IZ: 1,13, 1,57).
NAME OF THE MEDICINAL PRODUCT Elebrato Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed
IME ZDRAVILA Elebrato Ellipta 92 mikrogramov/55 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni
Rinsing your mouth out with water immediately after using Elebrato Ellipta may help prevent this side effect.
Nastanek tega neželenega učinka lahko pomaga preprečiti izpiranje ust z vodo takoj po uporabi zdravila Elebrato
Elebrato Ellipta should be used with caution in patients with narrow-angle glaucoma or urinary retention.
Zdravilo Elebrato Ellipta je treba uporabljati previdno pri bolnikih z glavkomom z ozkim zakotjem ali retenco urina.
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).
V študiji FULFIL je bil delež bolnikov, ki so bili odzivni po TDI (opredeljeno kot vsaj 1 enota) značilno večji (p < 0,001) pri zdravilu Elebrato Ellipta v primerjavi z BUD/FOR (61 % v primerjavi z 51 %; RO 1,61; 95 % IZ: 1,33, 1,95).
Don't use Elebrato Ellipta: - if you are allergic to fluticasone furoate, umeclidinium, vilanterol or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na flutikazonfuroat, umeklidinij, vilanterol ali katero koli sestavino tega zdravila
How to use Elebrato Ellipta
Kako uporabljati zdravilo Elebrato Ellipta
Pneumonia (infection of the lung) in COPD patients (common side effect) Tell your doctor if you have any of the following while using Elebrato Ellipta - these could be symptoms of a lung infection:
Svojemu zdravniku morate povedati, če imate med jemanjem zdravila Elebrato Ellipta kar koli od naslednjega, ker so to lahko simptomi okužbe pljuč:
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1237/003
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/17/1237/003
Elebrato Ellipta contains lactose
Zdravilo Elebrato Ellipta vsebuje laktozo
Comparison Elebrato vs.
Primerjava zdravila Elebrato z UMEC/VI
One fatal case of pneumonia was reported in a patient who received Elebrato Ellipta.
Med bolniki, ki so prejemali zdravilo Elebrato Ellipta, je bil zabeležen en primer pljučnice s smrtnim izidom.
What Elebrato Ellipta is and what it is used for
Kaj je zdravilo Elebrato Ellipta in za kaj ga uporabljamo Kaj je zdravilo Elebrato Ellipta
There was no effect of race on pharmacokinetic parameters of umeclidinium or vilanterol in subjects with COPD.
Pri preiskovancih s KOPB rasa ni vplivala na farmakokinetične parametre umeklidinija ali vilanterola.
No effect of verapamil was observed on umeclidinium or vilanterol Cmax.
Verapamil ni vplival na Cmax umeklidinija ali vilanterola.
What Elebrato Ellipta contains The active substances are fluticasone furoate, umeclidinium bromide and vilanterol.
Zdravilne učinkovine so flutikazonfuroat, umeklidinijev bromid in vilanterol.
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.
Nočna prebujanja V študiji IMPACT je zdravilo Elebrato Ellipta statistično značilno bolj zmanjšalo povprešno število nočnih prebujanj zaradi KOPB kot FF/VI (-0,05; 95 % IZ: -0,08, -0,01; p = 0,005) ali UMEC/VI (-0,10; 95 % IZ:
In a pre- and post-natal study, subcutaneous administration of umeclidinium to rats resulted in lower maternal body weight gain and food consumption and slightly decreased pre-weaning pup body weights in dams given 180 micrograms/kg/day dose (approximately 61-fold the human clinical exposure of umeclidinium at a daily dose of 55 micrograms, based on AUC).
V pre- in postnatalni študiji je subkutano dajanje umeklidinija pri podganah povzročilo manjše maternalno povečanje telesne mase in uživanje hrane ter rahlo manjšo telesno maso mladičev pred odstavitvijo pri samicah-materah, ki so dobivale odmerek
Elebrato Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/umeclidinium/vilanterol
Elebrato Ellipta 92 mikrogramov/55 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni flutikazonfuroat/umeklidinij/vilanterol
Treatment with Elebrato Ellipta should be discontinued immediately if paradoxical bronchospasm occurs.
Če se pojavi paradoksni bronhospazem, je treba zdravljenje z zdravilom Elebrato Ellipta nemudoma prenehati.
In IMPACT, the proportion of patients who were CAT responders at week 52 was significantly higher (p<0.001) for patients treated with Elebrato Ellipta (42%) compared with FF/VI (37%; OR 1.24; 95% CI: 1.14, 1.36) and UMEC/VI (36%; OR 1.28; 95% CI: 1.15, 1.43).
V študiji IMPACT je bil delež bolnikov, ki so bili po 52. tednih opredeljeni kot odzivni glede na CAT značilno večji (p < 0,001) med prejemniki zdravila Elebrato Ellipta (42 %) kot med prejemniki FF/VI (37 %; RO 1,24; 95 % IZ: 1,14, 1,36) in UMEC/VI (36 %; RO 1,28; 95 % IZ: 1,15,
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Elebrato Ellipta 92 /55 /22 mcg inhalation powder fluticasone furoate/umeclidinium/vilanterol
IME ZDRAVILA IN POT(I) UPORABE Elebrato Ellipta 92 /55 /22 µg prašek za inhaliranje fluticasonum furoas/ umeclidinium/ vilanterolum za inhaliranje
If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your Elebrato Ellipta inhaler:
Če se vam takoj po uporabi inhalatorja Elebrato Ellipta pojavi tiščanje v prsih, kašelj, piskajoče dihanje ali težko dihanje:
NAME OF THE MEDICINAL PRODUCT Elebrato Ellipta 92/55/22 mcg inhalation powder fluticasone furoate/umeclidinium/vilanterol
Elebrato Ellipta 92/55/22 µg prašek za inhaliranje fluticasonum furoas/ umeclidinium/ vilanterolum
A higher percentage of patients receiving Elebrato Ellipta responded with a clinically meaningful improvement in SGRQ total score in FULFIL at week 24 compared with BUD/FOR (50% and 41% respectively), odds ratios of response vs. non-response (OR) (1.41; 95% CI: 1.16, 1.70) and in IMPACT at week 52 compared with FF/VI and UMEC/VI (42%, 34% and 34% respectively), OR vs. FF/VI (1.41; 95% CI:1.29, 1.55) and OR vs. UMEC/VI (1.41; 95% CI: 1.26, 1.57); all treatment comparisons were statistically significant (p<0.001).
V študiji IMPACT se je v 52. tednu celotna ocena po SGRQ klinično pomembno izboljšala pri višjem odstotku bolnikov, ki so prejemali zdravilo Elebrato Ellipta, v primerjavi s tistimi, ki so prejemali kombinaciji FF/VI in UMEC/VI (42 %, 34 % in 34 %), RO v primerjavi s kombinacijo FF/VI (1,41; 95 % IZ: 1,29, 1,55) in RO v primerjavi s kombinacijo UMEC/VI (1,41; 95 % IZ: 1,26, 1,57).
How to store Elebrato Ellipta
Shranjevanje zdravila Elebrato Ellipta
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).
BUD/FOR (-2,2 enoti; 95 % IZ: -3,5, -1,0) kot v študiji IMPACT (52. teden) v primerjavi s FF/VI (-1,8 enot; 95 % IZ: -2,4, -1,1) in UMEC/VI (-1,8 enot; 95 % IZ: -2,6, -1,0).
Following repeat dosing of inhaled umeclidinium/vilanterol, steady state was achieved within 6 days with up to 1.5-fold accumulation.
Po večkratnem odmerjanju inhalirane kombinacije umeklidinij/vilanterol je bilo stanje dinamičnega ravnovesja doseženo v 6 dneh; kopičenje je bilo do
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 sestavljajo svetlosivo plastično telo, pokrovček ustnika bež barve in števec odmerkov.
No clinically relevant differences requiring dose adjustment based on race, gender or weight were observed in fluticasone furoate, umeclidinium or vilanterol systemic exposure.
Pri sistemski izpostavljenosti flutikazonfuroatu, umeklidiniju ali vilanterolu niso opazili nobenih klinično pomembnih razlik, ki bi zahtevale prilagoditev odmerka glede na raso, spol ali telesno maso
Package leaflet: Information for the patient Elebrato Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/umeclidinium/vilanterol
Navodilo za uporabo Elebrato Ellipta 92 mikrogramov/55 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni flutikazonfuroat/umeklidinij/vilanterol
Don't take a double dose to make up for a forgotten dose.
Če ste pozabili uporabiti zdravilo Elebrato Ellipta Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
In FULFIL, the proportion of patients who were CAT responders (defined as 2 units below baseline or lower) at week 24, was significantly higher (p<0.001) for patients treated with Elebrato Ellipta compared with BUD/FOR (53% vs. 45%; OR 1.44; 95% CI: 1.19, 1.75).
(opredeljeno z zmanjšanjem izhodiščne vrednosti za ≥ 2 enoti) značilno večji (p < 0,001) med prejemniki zdravila Elebrato Ellipta kot med prejemniki BUD/FOR (53 % v primerjavi s 45 %; RO 1,44; 95 % IZ: 1,19, 1,75).
Elebrato Ellipta
Ellipta.
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).
V študiji IMPACT je zdravljenje z zdravilom Elebrato Ellipta zmanjšalo letni delež hudih poslabšanj (tj. poslabšanj, ki so zahtevala sprejem v bolnišnico ali so se končala s smrtnim izidom) za 13 % v primerjavi s
If you stop using Elebrato Ellipta
Ne uporabljajte zdravila Elebrato Ellipta:
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.
Zdravilo Elebrato Ellipta je značilno izboljšalo (p < 0,001) zdravstveno kakovost življenja (merjeno s celotno oceno SGRQ (St. George's Respiratory Questionnaire) tako v študiji FULFIL (24. teden) v primerjavi z
This might be associated with insufficient access to drinking water.
To je lahko povezano s pomanjkanjem dostopa do pitne vode.
Change heavily contaminated clothes as soon as possible and wash before re-use.
Močno kontaminirana oblačila čim prej slecite in jih pred ponovno uporabo operite.
The acaricidal effect may be due mainly to the low pH of the formulation.
Akaricidni učinek se morda pojavi predvsem zaradi nizkega pH formulacije.
− Children should not come into contact with this veterinary medicinal product.
− Otroci ne smejo priti v stik s tem zdravilom.
ATCvet code: QP53AG30
Oznaka ATC vet: QP53AG30.
Before use, the product should be 25 to 35 °C warm, and then shaken well.
Pred uporabo mora biti zdravilo ogreto na temperaturo med 25 in 35 °C, nato ga dobro pretresite.
Sachets are perforated for opening.
Vrečice so perforirane za odpiranje.
Ensure, therefore, that treated bees have sufficient access to drinking water.
Zato poskrbite, da bodo zdravljene čebele imele dostop do zadostne količine pitne vode.
Opened sachets should not be stored.
Odprtih vrečic ne smete shranjevati.
− Do not eat, drink or smoke while using the product.
− Med uporabo tega zdravila ne smete jesti, piti ali kaditi.
Determine the colony size and number of occupied bee spaces to be treated, and select the correct amount of product required.
Določite velikost kolonije in število zasedenih čebeljih presledkov, ki bodo zdravljeni, ter pravilno izberite potrebno količino zdravila.
The dose should carefully be adjusted to the colony size (see dosing table).
Odmerek je treba skrbno prilagoditi velikosti kolonije (glejte preglednico odmerjanja).
Threshold for first treatment
Mejna vrednost za prvo zdravljenje
The pharmacokinetics of VarroMed have not been studied.
Farmakokinetika zdravila VarroMed ni bila raziskana.
Avoid contact with the skin, eyes and mucous membranes.
Izogibajte se stiku s kožo, očmi in sluznicami.
The excipients, listed in section 6.1 of the SPC areeither allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this product.
Pomožne snovi, navedene v poglavju 6.1 SPC, tabela 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo(ES) št. 470/2009.
Interaction with other medicinal products and other forms of interaction None known.
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Niso znane.
The concomitant use of other acaricidal products should be avoided because increased toxicity to bees might occur.
Treba se je izogibati sočasni uporabi drugih akaricidnih zdravil, ker lahko pride do povečane toksičnosti za čebele.
Winter (broodless)
Zima (brez zalege)
Cardboard box containing 12 single-dose sachets (foil PETP/ Al /LDPE), each containing 15 ml dispersion.
Kartonska škatla z 12 enoodmernimi vrečicami (iz folije PETP/Al/LDPE), od katerih vsaka vsebuje 15 ml disperzije.
The following dosing scheme applies:
Velja naslednja shema odmerjanja:
Do not use the veterinary medicinal product if you notice visible signs of deterioration of the product.
Ne uporabite zdravila, če opazite vidne znake kvarjenja.
+43 6219 20645 30 (fax) info@beevital.com
+43 6219 20645 30 (telefaks) info@beevital.com
Box containing 1 bottle of 555 ml dispersion.
Škatla, v kateri je 1 plastenka s 555 ml disperzije.
It is advised to check regularly that the queen is present, but avoid disturbing the hives in the days following treatment.
Priporočljivo je redno preverjanje prisotnosti matice, vendar se v dneh po zdravljenju izogibajte povzročanju motenj v panjih.
Excipients: Caramel colour (E150d)
Pomožna(pomožne) snov(i): karamelno barvilo (E150d)
Treatment should be conducted as soon as possible in late summer/early autumn with
Zdravljenje je treba izvesti čim prej v poznem poletju/zgodnji jeseni, ko
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Active substances:
NAVEDBA UČINKOVIN(E) IN DRUGE(IH) SESTAVIN Zdravilna(e) učinkovina(e):