natgillin/translations-raw huggingface dataset:
If you are given more Methylthioninium chloride Proveblue than you should As this medicine will be given to you whilst you are in hospital, it is unlikely that you will be given too much or too little, however, tell your doctor if you notice one of the following adverse reactions: - feeling sick, - stomach pain, - chest pain, - dizziness, - headache, - sweating, - confusion, - an increase in methaemoglobin (an abnormal form of haemoglobin in the blood), - high blood pressure, - shortness of breath, - abnormally fast beating of the heart, - tremor, - skin discolouration.
Če ste prejeli večji odmerek zdravila Metiltioninijev klorid Proveblue, kot bi smeli Ker boste to zdravilo prejeli v bolnišnici, ni verjetno, da ga boste prejeli preveč ali premalo, vendar pa obvestite svojega zdravnika, če opazite enega od naslednjih neželenih učinkov: - siljenje na bruhanje, - bolečine v želodcu, - bolečine v prsih, - omotico, - glavobol, - potenje, - zmedenost, - zvišanje ravni methemoglobina (nenormalne oblike hemoglobina v krvi), - povišan krvni tlak, - zadihanost, - nenormalno hitro bitje srca, - tresenje, - obarvanje kože.
Methylthioninium chloride may cause a photosensitivity reaction in the skin (sunburn-like reaction) when exposed to strong light sources, such as light therapy, lights in operating rooms and pulse oximeters.
Metiltioninijev klorid lahko povzroči fotosenzitivnostno reakcijo kože (reakcijo, podobno sončni opeklini) pri izpostavljenosti močnim virom svetlobe, npr. pri svetlobni terapiji, lučeh v operacijskih dvoranah in pulznih oksimetrih.
Methylthioninium chloride Proveblue is not an in vitro substrate for BCRP or OCT2 and is not an in vitro inhibitor of BCRP, OAT1 or OAT3.
Zdravilo Metiltioninijev klorid Proveblue ni in vitro substrat BCRP ali OCT2 in ni in vitro zaviralec BCRP, OAT1 ali OAT3.
5 ampoules of 2 ml 20 ampoules of 2 ml 10 mg/2 ml
5 ampul po 2 ml 20 ampul po 2 ml 10 mg/2 ml
How to store Methylthioninium chloride Proveblue Contents of the pack and other information
Shranjevanje zdravila Metiltioninijev klorid Proveblue Vsebina pakiranja in dodatne informacije
Intravenous use only For slow intravenous injection
Za počasno intravensko injiciranje.
When used in combination with these medicines methylthioninium chloride may cause serotonin syndrome, which can be potentially life-threatening.
Pri uporabi v kombinaciji s temi zdravili lahko metiltioninijev klorid povzroči serotoninski sindrom, ki je lahko tudi smrtno nevaren.
Methylthioninium chloride should be avoided in patients receiving medicinal products that enhance serotonergic transmission because of the potential for serious CNS reactions, including potentially fatal serotonin syndrome.
Metiltioninijevemu kloridu se je treba izogniti pri bolnikih, ki prejemajo zdravila, ki povečujejo serotonergični prenos, zaradi potenciala za hude učinke na osrednji živčni sistem, vključno s serotoninskim sindromom, ki lahko ima smrten izid .
Do not use Methylthioninium chloride Proveblue if the solution is discoloured, cloudy, turbid, or a precipitate or particles are present.
Zdravila Metiltioninijev klorid Proveblue ne uporabljajte, če je raztopina spremenjene barve, motna, gosta ali vsebuje precipitat ali delce.
It must especially not be mixed with sodium chloride 9 mg/ml (0.9%) solution for injection because it has been demonstrated that chloride reduces the solubility of methylthioninium chloride.
Zlasti se ga ne sme mešati z raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje, ker je bilo dokazano, da kloridni ioni zmanjšajo topnost metiltioninijevega klorida.
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema methemoglobinemija,
• Patients with nitrite-induced methaemoglobinaemia during treatment of cyanide poisoning
• Bolniki z methemoglobinemijo, povzročeno z nitritom med zdravljenjem zastrupitve s cianidom.
Electrocardiogram (ECG) and blood pressure should be monitored during and after treatment with Methylthioninium chloride Proveblue as hypotension and cardiac arrhythmia are potential adverse reactions (see section 4.8).
Med zdravljenjem z zdravilom Metiltioninijev klorid Proveblue in po njem sta potrebna ektrokardiogram (EKG) nadzor in nadzor krvnega tlaka, saj sta hipotenzija in srčna aritmija možna neželena učinka (glejte poglavje 4.8).
Not known (frequency cannot be estimated from the available data): - serotonin syndrome when Methylthioninium chloride Proveblue has been taken with certain medicines to treat depression or anxiety, see section 2 - decreased haemoglobin (protein in red blood cells that carry oxygen in the blood) levels may be reported during blood tests - reduction in red blood cells which may turn your skin pale and make you breathless and weak - local tissue damage at the injection site - jaundice (yellowing of the skin and eyes) - this has only been reported in infants - problems with speech - high or low blood pressure - agitation - lack of oxygen - irregular heartbeat, including an abnormally slow or fast beating of the heart - severe allergic reactions (so called anaphylactic reaction which may cause your throat or face to swell, difficulty breathing or a severe rash) - an increase in methaemoglobin (an abnormal form of haemoglobin in the blood) - shortness of breath - confusion - shaking - hives - fever - rapid breathing - dilated pupils - discoloured stools.
• Neznana pogostnost (pogosnosti iz razpoložljivih podatkov ni mogoče oceniti) - serotoninski sindrom, ko se je zdravilo Metiltioninijev klorid Proveblue jemalo z določenimi zdravili za zdravljenje depresije ali anksioznosti; glejte poglavje 2 - testi krvi lahko pokažejo znižanje ravni hemoglobina (beljakovine v rdečih krvnih celicah, ki prenaša kisik v krvi) - zmanjšanje števila rdečih krvnih celic, zaradi česar lahko vaša koža postane bleda ter ste zasopli in slabotni - poškodba tkiva na mestu injiciranja - zlatenica (porumenelost kože in oči) - o njej so poročali samo pri dojenčkih - težave pri govorjenju - visok ali nizek krvni tlak - vznemirjenost - pomanjkanje kisika - nepravilno bitje srca, vključno z nenormalno počasnim ali hitrim bitjem srca - hude alergijske reakcije (tako imenovana anafilaktična reakcija, ki lahko povzroči otekanje grla ali obraza, težave pri dihanju ali hude izpuščaje) - zvišanje ravni methemoglobina (nenormalne oblike hemoglobina v krvi) - zadihanost - zmedenost - tresenje - koprivnica - zvišana telesna temperatura - hitro dihanje - razširjene zenice - obarvano blato.
Hyperbilirubinaemia has been observed in infants after administration of 20 mg/kg methylthioninium chloride.
Hiperbilirubinemija je bila opažena pri dojenčkih po aplikaciji 20 mg/kg metiltioninijevega klorida.
Caution should be exercised in the course of treatment with methylthioninium chloride as this may exacerbate Heinz body formation and haemolytic anaemia.
Med zdravljenjem z metiltioninijevim kloridom je potrebna previdnost, saj lahko ta poslabša nastajanje Heinzovih telesc in hemolitično anemijo.
An equivocal evidence of carcinogenic activity was observed in female mice.
Nezanesljiv dokaz kancerogene aktivnosti je bil opažen pri samicah miši.
It must not be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection because it has been demonstrated that chloride reduces the solubility of methylthioninium chloride.
Ne sme se ga redčiti z raztopino natrijevega klorida 9 mg/ml (0,9%) za injiciranje, ker je bilo dokazano, da kloridni ioni zmanjšajo topnost metiltioninijevega klorida.
Solution for injection (injection) Clear dark blue solution with a pH value between 3.0 and 4.5 Osmolality is usually between 10 and 15 mOsm/kg.
raztopina za injiciranje (injekcija) Bistra temnomodra raztopina s pH vrednostjo med 3,0 in 4,5.
What you need to know before you are given Methylthioninium chloride Proveblue
Kaj morate vedeti, preden boste uporabili zdravilo Metiltioninijev klorid Proveblue
Individuals with methaemoglobinaemia
Osebe z methemoglobinemijo
Methylthioninium chloride Proveblue is not an in vitro inducer of CYP2B6 and CYP3A4.
Zdravilo Metiltioninijev klorid Proveblue ni in vitro induktor CYP2B6 in CYP3A4.
Please refer to section 4.4 for important safety information.
Za posebna opozorila in previdnostne ukrepe glejte poglavje 4.4.
A repeat dose (1 to 2 mg/kg body weight, i.e. 0.2-0.4 ml/kg body weight) may be given one hour after the first dose in cases of persistent or recurrent symptoms or if methaemoglobin levels remain significantly higher than the normal clinical range.
Ponovni odmerek (1 do 2 mg/kg telesne mase, tj. 0,2-0,4 ml/kg telesne mase) se lahko aplicira eno uro po prvem odmerku v primeru perzistentnih ali ponavljajočih se simptomov ali če ravni methemoglobina ostanejo znatno višje od običajnih kliničnih vrednosti.
Methylthioninium chloride may cause a cutaneous photosensitivity reaction when exposed to strong light sources, such as phototherapy, those found in operating theatres or locally from illuminating devices such as pulse oximeters.
Metiltioninijev klorid lahko povzroči fotosenzitivnostno reakcijo kože pri izpostavljenosti močnim virom svetlobe, ki se uporabljajo npr. pri fototerapiji in v operacijskih dvoranah, ali lokalnim virom svetlobe iz pripomočkov, ki oddajajo svetlobo, kot je npr. pulzni oksimeter.
It is unknown whether methylthioninium chloride is excreted in human breast milk.
Ni podatkov o tem, ali se metiltioninijev klorid izloča v materino mleko.
Your skin may turn blue blue or green urine numbness and tingling abnormal taste in mouth nausea
- moder ali zelen urin - odrevenelost in mravljinčenje - nenormalen okus v ustih - siljenje na bruhanje
A repeat dose (0.3 to 0.5 mg/kg body weight, i.e. 0.06-0.1 ml/kg body weight) may be given one hour after the first dose in cases of persistent or recurrent symptoms or if methaemoglobin levels remain significantly higher than the normal clinical range (see section 4.4 for important safety information).
Ponovni odmerek (0,3 do 0,5 mg/kg telesne mase, tj. 0,06-0,1 ml/kg telesne mase) se lahko aplicira eno uro po prvem odmerku v primeru trdovratnih ali ponavljajočih se simptomov ali če ravni methemoglobina ostanejo znatno višje od običajnih kliničnih vrednosti (za posebna opozorila in previdnostne ukrepe glejte poglavje 4.4).
Skin discoloration (blue)
Bolezni sečil kromaturija (modrozeleno)
Death occurred in 2 infants after administration of 20 mg/kg methylthioninium chloride.
Pri 2 dojenčkih je nastopila smrt po aplikaciji 20 mg/kg metiltioninijevega klorida.
A repeat dose (0.3 to 0.5 mg/kg body weight, i.e. 0.06-0.1 ml/kg) may be given after one hour in case of persistence or recurrence of symptoms.
Ponovni odmerek (0,3 do 0,5 mg/kg telesne mase, tj. 0,06-0,1 ml/kg) se lahko da eno uro po prvem odmerku v primeru trdovratnih ali ponavljajočih se simptomov.
22 rue Marc Donadille, 13013 Marseille, France
22 rue Marc Donadille, 13013 Marseille, Francija
In vivo, in low concentration, methylthioninium chloride speeds up the conversion of methaemoglobin to haemoglobin.
Metiltioninijev klorid in vivo v nizkih koncentracijah pospeši pretvorbo methemoglobina v hemoglobin.
In vitro, methylthioninium chloride has been shown to reduce motility of human sperm in a dose dependant manner.
Študija in vitro je pokazala, da metiltioninijev klorid v odvisnosti od odmerka zmanjša gibljivost človeškega semena.
What Methylthioninium chloride Proveblue contains - The active substance is methylthioninium chloride.
Kaj vsebuje zdravilo Metiltioninijev klorid Proveblue - Učinkovina je metiltioninijev klorid.
This medicine may be diluted in 50 ml glucose 50 mg/ml (5%) solution for injection to avoid local pain, in particular in children.
To zdravilo se lahko razredči v 50 ml raztopine glukoze 50 mg/ml (5 %) za injiciranje, da se izognemo lokalni bolečini, zlasti pri otrocih.
Methylthioninium chloride may cause serious or fatal serotonergic syndrome when used in combination with serotonergic drugs.
Metiltioninijev klorid lahko pri uporabi v kombinaciji s serotonergičnimi zdravili povzroči hud ali smrten serotoninski sindrom.
Each box contains a tray with 20 ampoules of 2 ml.
Ena škatla vsebuje podstavek s 20 ampulami po 2 ml.
Methylthioninium chloride Proveblue is an in vitro inhibitor of P-gp.
Zdravilo Metiltioninijev klorid Proveblue je in vitro zaviralec P-gp.
You should not be given this medicine after the expiry date which is printed on the carton and the ampoule labels after EXP.
Tega zdravila ne smete uporabiti po datumu izteka roka uporabnosti, ki je naveden na škatli, pretisnem omotu in nalepkah na ampulah poleg oznake Uporabno do. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
How to store Methylthioninium chloride Proveblue
Kako uporabljati zdravilo Metiltioninijev klorid Proveblue
No evidence of carcinogenic activity was observed in female rats.
Pri samicah podgan ni bilo opaziti dokazov kancerogene aktivnosti.
Methylthioninium chloride is a potent inhibitor of the transporters OCT2, MATE1 and MATE2-K.
Metiltioninijev klorid je močan zaviralec prenašalcev OCT2, MATE1 in MATE2-K. Klinične posledice zaviranja niso znane.
Musculoskeletal and connective tissue disorder
Bolezni mišično-skeletnega sistema in vezivnega tkiva bolečina v udu zelo pogosti
PROVEPHARM SAS 22 rue Marc Donadille, 13013 Marseille, France
Provepharm SAS 22 rue Marc Donadille, 13013 Marseille, Francija
Provepharm SAS 22 rue Marc Donadille, 13013 Marseille, France
PROVEPHARM SAS 22 rue Marc Donadille, 13013 Marseille, Francija
The recommended dose is 0.3 to 0.5 mg/kg body weight, i.e. 0.06 to 0.1 ml/kg, over a period of 5 minutes.
Priporočeni odmerek je 0,3 do 0,5 mg/kg telesne mase, tj. 0,06 do 0,1 ml/kg telesne mase, čas trajanja injiciranja pa 5 minut.
The usual dose is 1 to 2 mg per kg body weight, i.e. 0.2-0.4 ml per kg body weight, given over a period of 5 minutes.
Običajni odmerek je 1 do 2 mg na kg telesne mase, tj. 0,2-0,4 ml na kg telesne mase, čas trajanja injiciranja pa 5 minut.
Its use in parathyroid surgery (not indicated) has induced adverse CNS effects when administered concomitantly with serotonergic medicinal products (see section 4.5).
Njegova sočasna uporaba s serotogeničnimi zdravili pri operaciji obščitnične žleze (za kar zdravilo ni indicirano) je povzročila neželene učinke na osrednjem živčevju (glejte poglavje 4.5).
After intravenous administration Methylthioninium chloride Proveblue is rapidly taken up by the tissues.
Po intravenski aplikaciji tkiva hitro absorbirajo zdravilo Metiltioninijev klorid Proveblue.
Methylthioninium chloride Proveblue has been observed to stain tissues selectively.
Opaženo je bilo, da zdravilo Metiltioninijev klorid Proveblue selektivno obarva tkiva.
Methylthioninium chloride Proveblue is hypotonic and may be diluted in 50 ml glucose 50 mg/ml (5%) solution for injection to avoid local pain, in particular in paediatric population.
Zdravilo Metiltioninijev klorid Proveblue je hipotonično in se ga lahko razredči v 50 ml glukoze 50 mg/ml (5 %) raztopina za injiciranje, da se izognemo lokalni bolečini, zlasti pri pediatrični populaciji.
Each box contains a tray with 5 ampoules of 2 ml.
Ena škatla vsebuje podstavek s 5 ampulami po 2 ml.
Each box contains a tray with 5 ampoules of 10 ml.
Ena škatla vsebuje podstavek s 5 ampulami po 10 ml.
Each 10 ml ampoule contains 50 mg methylthioninium chloride.
Ena 10 ml ampula vsebuje 50 mg metiltioninijevega klorida.
Methylthioninium chloride Proveblue is for administration by a healthcare professional.
Zdravilo Metiltioninijev klorid Proveblue sme dati samo zdravstveni delavec.
Each 2 ml ampoule contains 10 mg methylthioninium chloride.
Ena 2 ml ampula vsebuje 10 mg metiltioninijevega klorida.
Each ml of solution contains 5 mg methylthioninium chloride.
En ml raztopine vsebuje 5 mg metiltioninijevega klorida.
Methylthioninium chloride Proveblue may be diluted in 50 ml glucose 50 mg/ml (5%) solution for injection to avoid local pain, in particular in paediatric population.
Zdravilo Metiltioninijev klorid Proveblue se lahko razredči v 50 ml raztopine glukoze 50 mg/ml (5 %) za injiciranje, da se izognemo lokalni bolečini, zlasti pri pediatrični populaciji.
Methylthioninium chloride Proveblue 5 mg/ml solution for injection
Metiltioninijev klorid Proveblue 5 mg/ml raztopina za injiciranje
Immune system disorders
Bolezni imunskega sistema anafilaktične reakcije neznana
Methylthioninium chloride Proveblue 5 mg/ml solution for injection Methylthioninium chloride
Metiltioninijev klorid Proveblue 5 mg/ml raztopina za injiciranje metiltioninijev klorid
Methylthioninium chloride Proveblue 5 mg/ml injection methylthioninium chloride
Metiltioninijev klorid Proveblue 5 mg/ml injekcija metiltioninijev klorid
Local tissue necrosis at the injection site Not known Injection site pain
Splošne težave in spremembe na mestu aplikacije bolečine v prsih pogosti nekroza lokalnega tkiva na mestu aplikacije neznana bolečina na mestu injiciranja pogosti
Intravenous use only
Samo za intravensko uporabo.
Each carton contains a tray with 5 or 20 ampoules of 2 ml in blister.
Ena škatla vsebuje podstavek s 5 ampulami po 10 ml. Ena škatla vsebuje podstavek s 5 ali 20 ampulami po 2 ml. Na trgu morda ni vseh navedenih pakiranj.
Monitoring tests You will undergo monitoring tests during and after treatment with Methylthioninium chloride Proveblue.
Med zdravljenjem z zdravilom Metiltioninijev klorid Proveblue in po njem boste opravili kontrolne teste.
The usual dose is 1 to 2 mg per kilogram of your body weight, i.e. 0.2 to 0.4 ml per kilogram given over a period of 5 minutes.
Odrasli, otroci, starejši od 3 mesecev, in starejše osebe Običajni odmerek je 1 do 2 mg na kilogram telesne mase, tj. 0,2 do 0,4 ml na kilogram telesne mase, čas trajanja injiciranja pa 5 minut.
Gastrointestinal disorders
Testi za spremljanje
Serotonin Syndrome with concomitant use of serotonergic drugs (see section 4.4 and section 4.5).
Bolezni živčevja omotica zelo pogosti glavobol pogosti tesnoba pogosti tremor neznano zvišana telesna temperatura neznano afazija neznano parestezija zelo pogosti disgevzija zelo pogosti serotoninski sindrom pri sočasni uporabi serotonergičnih zdravil (glejte poglavje 4.4 in poglavje 4.5)
It is recommended not to exceed a cumulative dose for the course of treatment of 4 mg/kg in patients with dapsone-induced methaemoglobinaemia.
Pri bolnikih z methemoglobinemijo, povzročeno z dapsonom, se priporoča, da se ne preseže kumulativnega odmerka celotnega zdravljenja 4 mg/kg.
The responses were submitted on 25 November 2003.
Odgovori so bili predloženi 25. novembra 2003.
B-1070 Bruxelles Belgium
B-1070 Bruxelles Belgija
I-20090 Assago (MI) Italy
I-20090 Assago (MI) Italija
Conclusions and recommendations
Sklepi in priporočila
E-08014 Barcelona Spain
E-08014 Barcelona Španija
2.1 Residue depletion studies
2.1 Raziskave izginevanja ostankov
29 av Tony Garnier F-69007 Lyon France
29 av Tony Garnier F-69007 Lyon Francija
For the 4th study, the statistical method could not be used due to large variation in the data set.
Za četrto raziskavo statistične metode ni bilo moč uporabiti zaradi velike variacije podatkov.
AMSTELVEEN The Netherlands
AMSTELVEEN Nizozemska
For 3 studies the data allowed the use of the statistical approach.
Prve tri raziskave so omogočile uporabo statističnega pristopa.
Muscle: 50 µg/kg Fat: 250 µg/kg Liver: 1500 µg/kg Kidney: 300 µg/kg Milk: 20 µg/kg
Mišica: 50 µg/kg Maščoba: 250 µg/kg Jetra: 1500 µg/kg Ledvice: 300 µg/kg Mleko: 20 µg/kg
The questions identified related to the withdrawal periods and were submitted to the Marketing Authorisation Holders on 28 July 2003.
Vprašanja, ki so se nanašala na obdobja karence, so bila predložena imetnikom dovoljenj za promet 28. julija 2003.
All studies were conducted according to GLP-guidelines and using the formulation as marketed in all relevant Member States and Norway in the correct dosage.
Vse raziskave so bile izvedene skladno s smernicami GLP in so vključevale farmacevtske oblike, ki se tržijo v vseh zadevnih državah članicah in na Norveškem v ustreznih odmerkih.
UK-Essex CM19 5TG United Kingdom
UK-Essex CM19 5TG Velika Britanija
Residue concentrations in this study showed a large variation.
Koncentracije zaostankov v tej študiji so bile zelo spremenljive.
The withdrawal period was calculated using either the statistical approach or the alternative approach, as appropriate according to the CVMP note for guidance approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95).
Karenca je bila izračunana ali s statističnim ali z alternativnim pristopom skladno z opombo CVMP za usmerjen pristop k usklajevanju karenčnih obdobij (EMEA/CVMP/036/95).
Eprinomectin was included in Annex I of Council Regulation 2377/90 and the following maximum residue limits were established for bovine species:
Eprinomektin je bil vključen v Dodatek I Uredbe Sveta 2377/90, kjer so bile določene naslednje najvišje mejne vrednosti zaostankov v govedu:
The withdrawal periods set for edible tissues by the different Member States diverge significantly, from 0 to 21 days.
Karenca za užitna tkiva se med državami članicami znatno razlikuje, in sicer od 0 do 21 dni.
However, this is not considered as causing difficulties to establish an appropriate withdrawal period.
Vendar to ne ovira določanja ustreznih obdobij karence.
The withdrawal period for milk of zero days as established in all the relevant Member States and Norway is unaffected.
To ne vpliva na karenco za mleko 0 dni, ki je uveljavljena v vseh državah članicah in na Norveškem.
Based on the results of the four different residue depletion studies conducted in adult cattle as well in calves, the longest calculated withdrawal period in meat and offal is 15 days (by statistical approach) or 14 days plus a safety margin (by alternative approach).
Na podlagi rezultatov štirih različnih raziskav izginevanja zaostankov, ki so bile izvedene pri odraslem govedu in teletih, je najdaljša izračunana karenca za meso in drobovino 15 dni (s statističnim pristopom) oz. 14 dni z varnostnim odmikom (z alternativnim pristopom).
Eprinex pour-on products contain eprinomectin, which is a semi-synthetic compound of the avermectin family, intended for the treatment of internal and external parasites in cattle including lactating cows.
Eprinex kožni polivi (pour on) vsebujejo eprinomektin, ki je polsintetična spojina iz skupine avermektinov in so namenjeni zdravljenju notranjih in zunanjih parazitoz pri govedu in kravah v obdobju laktacije.
Tissue residue concentrations exceeded the MRL after 1 day (in fat and muscle) and after 7 days (in liver, fat and muscle) but were below the MRL at 14 days post treatment.
Koncentracije zaostankov v tkivih so presegle vrednosti MRL po 1 dnevu (v maščobi in mišici) in po 7 dneh (v jetrih, maščobi in mišici), vendar so padle pod MRL po 14. dnevu od zdravljenja.
The product has been authorised in the European Union (all Member States except Greece) and in Norway as a pour on solution for topical use.
Izdelek je bil v Evropski uniji (v vseh državah članicah, razen v Grčiji) in na
Strength Pharmaceutical form Route of administration Animal species
Farmacevtska oblika Način dajanja zdravila Vrsta živali
Therefore, the CVMP recommended that all marketing authorisations pour-on solutions containing eprinomectin for topical use in bovine species known as Eprinex or variations of that name as referred to in Annex I a withdrawal period for meat and offal of 15 days is set.
Zato CVMP priporoča, da se za vsa dovoljenja za promet kožnih polivov, ki vsebujejo eprinomektin za topikalno uporabo pri vrstah goveda, imenovanih Eprinex oz. variacijami imen, ki so navedene v Dodatku I, določi Karenca za meso in drobovino 15 dni.
Solution for external use Topical
Raztopina za zunanjo uporabo
Tissue residue concentrations were highest after 3 days and declined afterwards and did not exceeded the MRL at any time point.
Koncentracije zaostankov v tkivih so bile najvišje po 3 dneh, nato pa so padale in nikoli niso presegle vrednosti MRL.
In all studies, only perirenal fat was sampled and the residue concentration in dose site fat was not investigated.
V vseh raziskavah so bili odvzeti vzorci maščobe le perirenalno, maščoba na mestu nanosa odmerka pa ni bila preiskana za ostanke.
Two untreated control animals were slaughtered two days before treatment.
Dve nezdravljeni kontrolni živali sta bili zaklani dva dni pred zdravljenjem.