natgillin/translations-raw huggingface dataset:
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.
Change heavily contaminated clothes as soon as possible and wash before re-use. 
Što prije skinite jako kontaminiranu odjeću te je operite prije ponovne uporabe.
EXPIRY DATE EXP {month/year} Once opened, use immediately. 
ROK VALJANOSTI EXP {mjesec/godina} Nakon otvaranja, smjesta upotrijebite.
− This veterinary medicinal product is irritating to the skin and eyes. 
Ovaj veterinarsko-medicinski proizvod nadražuje kožu i oči.
Oxalic acid treatments administered in water are ineffective, but administration in sugar water improves efficacy by increasing its adhesion to the bees. 
Tretmani oksalnom kiselinom u vodi nisu učinkoviti, no primjena u vodi sa šećerom poboljšava učinkovitost tako što povećava adheziju na pčele.
Do not use the veterinary medicinal product if you notice visible signs of deterioration of the product. 
Ne koristite veterinarsko-medicinski proizvod ako primijetite vidljive znakove dotrajalosti proizvoda.
It is recommended to remove the wax bridges between the top bars of the frames before administration of the product. 
Preporučljivo je ukloniti voštane mostove između gornjih šipki prije primjene proizvoda.
This effect is considered to be associated with the oxalic acid in VarroMed, and increased with increasing doses and/or repeated treatments. 
Smatra se da je taj učinak povezan s oksalnom kiselinom u VarroMedu te da je učestaliji nakon povećanja doza i/ili ponavljanih tretmana.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box with 12 sachets 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Kartonska kutija s 12 vrećica
Keep the bottle in the outer carton in order to protect from light. 
Držati bocu u vanjskom kartonu radi zaštite od svjetla.
Opened sachets should not be stored. 
Otvorene vrećice ne smiju se čuvati.
Cardboard box containing 12 single-dose sachets (foil PETP/ Al /LDPE), each containing 15 ml dispersion. 
Kartonska kutija sadrži 12 jednodoznih vrećica (folija PETP/ Al /LDPE), od kojih svaka sadrži 15 ml disperzije.
Dose: Shake well before use. 
Doza: Dobro protresite prije uporabe.
Treatment should be conducted as soon as possible in late summer/early autumn with 
Tretman je potrebno što prije provesti u kasno ljeto/ranu
VarroMed is available in two pack sizes, multi-dose bottles (1 x 555 ml) and single-dose sachets (12 x 15 ml). 
VarroMed je dostupan u dvije veličine pakovanja, u višedoznim bocama (1 x 555 ml) i jednodoznim vrećicama (12 x 15 ml).
Not applicable (single treatment only). 
Nije primjenjivo (samo jedan tretman).
Formic acid probably kills Varroa mites by inhibiting electron transport in their mitochondria through the binding of cytochrome c oxidase, thereby inhibiting energy metabolism and may produce a neuroexcitatory effect on arthropod neurons after evaporation in the hive air (at least 500 ppm). 
Mravlja kiselina vjerojatno ubija grinje varoe onemogućivanjem prijenosa elektrona njihovim mitohondrijima vezivanjem citokrom c oksidaze, time onemogućujući metabolizam energije, i može stvoriti neuro-stimulacijski učinak na neuronima artropoda nakon isparavanja u zrak u košnici (najmanje 500 ppm).
VarroMed should only be used as part of an integrated Varroa control programme. 
VarroMed se smije primjenjivati samo u okviru cjelovitog programa za kontrolu Varroe.
6.2 Major incompatibilities 
Glavne inkompatibilnosti
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs 
PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE U PROMET B. UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE C. IZVJEŠĆE O MRL-ima
4.6 Adverse reactions (frequency and seriousness) 
4.6. Nuspojave (učestalost i ozbiljnost)
The multi-dose container has a graduated dosing scale for accurate dosing. 
Višedozni spremnik ima stupnjevitu doznu ljestvicu za precizno doziranje.
However, literature data show that oxalic acid is absorbed to a limited extent after topical application at therapeutic doses under normal beekeeping conditions. 
Međutim, podaci iz literature ukazuju da se oksalna kiselina apsorbira do ograničene mjere nakon topikalne primjene pri terapijskim dozama u normalnim uvjetima hranidbe pčela.
Not applicable (single treatment only) 
Nije primjenjivo (samo jedan tretman)
Pharmacotherapeutic group: Ectoparasiticides for topical use, including insecticides, organic acids, combinations 
Farmakoterapijska skupina: ektoparaziticidi za topikalnu primjenu, što uključuje insekticide, organske kiseline, kombinacije.
+49-(0)4554-9070-901 (fax) info@lichtenheldt.de 
+49-(0)4554-9070-901 (faks) info@lichtenheldt.de
VarroMed should not be used during the nectar flow, or when honey chambers are attached to the hive. 
VarroMed se ne smije primjenjivati tijekom cvjetne paše ili kada su komore za med pričvršćene za košnicu.
1x or 3x 
1x ili 3x
− Personal protective equipment consisting of protective clothing, acid-resistant gloves and glasses should be worn when handling the veterinary medicinal product. 
Pribor za osobnu zaštitu koji se sastoji od zaštitne odjeće, rukavica otpornih na kiseline i zaštitnih naočala treba koristiti pri rukovanju veterinarsko-medicinskim proizvodom.
Efficacy was only investigated in hives with low to moderate mite infestation rates. 
Učinkovitost je ispitana samo u košnicama s niskim do umjerenim stopama infestacije grinjama.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED 
14. DATUM KADA JE UPUTA O VMP-u ZADNJI PUTA ODOBRENA
Oxalic acid concentrations of 20% in a 50% sugar solution led to acute bee mortalities of more than 
Koncentracije oksalne kiseline od 20 % u 50 %-tnoj otopini šećera dovele su do akutne smrtnosti pčela u postotku od više od 60 %.
19 A - 5164 Seeham AUSTRIA 
A - 5164 Seeham
Repeated Treatment: 
Ponovljeni tretman:
Timing of application: the product should be used primarily at times when bees have low flight activity (late afternoon, evening). 
Vrijeme primjene: proizvod je potrebno primjenjivati prvenstveno u vrijeme kada pčele manje lete (kasno poslijepodne, u večernjim satima).
In case of accidental spillage into the eye(s), flush the eye(s) immediately with clear running water for 10 minutes. 
U slučaju da se nehotice prolije u oko (oči), smjesta isperite oko (oči) mlazom bistre tekuće vode 10 minuta.
In case of accidental overdose (e.g. spillage of a large quantity of VarroMed into a hive) the best counter measure includes exchanging the hive body and cleaning the frames with water from all visible spills of the dispersion. 
U slučaju nehotičnog predoziranja (npr. izlijevanja velike količine VarroMeda u košnicu), najbolje protumjere uključuju promjenu tijela košnice i čišćenje okvira vodom od svih vidljivih izljeva disperzije.
4.1 Target species 
4.1. Ciljne vrste životinja
Slightly brown to dark brown aqueous dispersion. 
Neznatno smeđa do tamno smeđa vodena disperzija.
3x up to 5x 
3x do najviše 5x
Keep the sachets in the outer carton in order to protect from light. 
Držati vrećice u vanjskom kartonu radi zaštite od svjetla.
The long-term tolerance of VarroMed has only been tested over 18 months, i.e. a negative impact of the product on queens or colony development after longer treatment periods cannot be excluded. 
Dugoročna tolerancija na VarroMed ispitivana je samo tijekom 18 mjeseci, tj. negativan učinak proizvoda na matice ili razvoj kolonije nakon duljih razdoblja primjene se ne može isključiti.
To avoid overdoses to individual bees, care should be taken to administer VarroMed evenly over the bees, particularly in the winter cluster. 
Kako bi se izbjeglo predoziranje pojedinih pčela, potrebno je voditi računa o tome da se VarroMed jednakomjerno primjenjuje na pčele, osobito u zimskom klupku.
It is assumed that oxalic acid acts via direct contact or by ingestion of oxalic haemolymph. 
Pretpostavlja se da oksalna kiselina djeluje na osnovi izravnog kontakta ili gutanja oksalne kisline putem hemolimfe.
The mode of action of oxalic acid against Varroa mites is unknown, but direct contact between the mites and oxalic acid is required. 
Način djelovanja oksalne kiseline protiv grinja varoe nije poznat, no potreban je izravan kontakt između grinja i oksalne kiseline.
In case of accidental spillage onto skin, wash the affected areas immediately with running water. 
U slučaju da se nehotice prolije na kožu, smjesta isperite zahvaćena područja tekućom vodom.
Do not use this veterinary medicinal product after the expiry date, which is stated on the carton after “EXP”. 
Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na kartonu poslije „EXP”.
The pharmacokinetics of formic acid in bees is not known. 
Farmakokinetički podaci o utjecaju mravlje kiseline na pčele nisu poznati.
75 mg Oxalic acid dihydrate 660 mg 
75 mg Dihidrat oksalne kiseline 660 mg
4.2 Indications for use, specifying the target species 
4.2. Indikacije za primjenu, navesti ciljne vrste životinja
The following dosing scheme applies: 
Primjenjuje se sljedeći režim doziranja:
Data have also shown that oxalic acid can be orally ingested by bees due to increased self-grooming after dermal application, which might lead to increased toxicity. 
Podaci također pokazuju da pčele tijekom pojačanog čišćenja mogu peroralno unijeti oksalnu kiselinu, nakon dermalne primjene, koja može dovesti do povećane toksičnosti.
Overdose (symptoms, emergency procedures, antidotes) Following the administration of a 10% solution of oxalic acid dihydrate in 50% sugar solution, permanent lesions in digestive and excretory organs were noted after 72 hours (h). 
Predoziranje (simptomi, hitni postupci, antidoti): Nakon primjene 10 %-tne otopine dihidrata oksalne kiseline u 50 %-tnoj otopini šećera, zapažene su trajne lezije u probavnim organima i organima za izlučivanje nakon 72 sata (h).
The treatment should be repeated twice more (that is to a maximum of 5 treatments), if more than 150 mites (colonies from the second year) or more than 90 mites (nucleus colonies in the first year) are detected on the floorboard within 6 days after the third administration. 
Tretman je potrebno još dvaput ponoviti (tako da se najviše primijeni 5 tretmana) ako se uoči više od 150 grinja (kolonije iz druge godine) ili više od 90 grinja (nukleus u prvoj godini) na podnici u roku od 6 dana nakon trećeg tretmana.
Caramel colour (E150d) Sucrose syrup Propolis tincture 20% Star anise oil Lemon oil 
Boja karamel (E150d) Sirup od saharoze Tinktura propolisa 20 % Ulje zvjezdastog anisa Limunovo ulje Monohidrat limunske kiseline
Repeated Treatments: 
Ponavljani tretmani:
Following treatment, worker bees with a protruding proboscis were found. 
Nakon primjene proizvoda, pronađene su pčele radilice s izbočenim rilcem.
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children. 
I DOSEGA DJECE” Čuvati izvan pogleda i dohvata djece.
CONTRAINDICATIONS Do not use during nectar flow. 
KONTRAINDIKACIJE Ne primjenjivati tijekom cvjetne paše.
− People with known sensitivity to formic acid or oxalic acid should administer the veterinary medicinal product with caution. 
Osobe preosjetljive na mravlju ili oksalnu kiselinu trebaju oprezno primjenjivati veterinarsko medicinski proizvod.
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. 
Komisije (EU) br. 37/2010 navedeno da određivanje MRL-a nije nužno ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EK) br. 470/2009 kada se primjenjuju u tim veterinarsko medicinskim proizvodima..
The treatment should be repeated twice more (that is to a maximum of 3 treatments), if more than 10 mites are detected on the floorboard within 6 days after the first treatment (maximum of 3 treatments). 
Tretman je potrebno dvaput ponoviti (tako da se najviše primijene 3 tretmana) ako se uoči više od 10 grinja na podnici u roku od 6 dana nakon prvog tretmana (najviše 3 tretmana).
Advice on correct administration 
SAVJETI ZA ISPRAVNU PRIMJENU
ADVICE ON CORRECT ADMINISTRATION 
Savjeti za ispravnu primjenu
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BeeVital GmbH Wiesenbergstrasse 19 A - 5164 Seeham AUSTRIJA