natgillin/translations-raw huggingface dataset:
Taking residue data from the studies into consideration, the first time point at which no values exceeded the MRL for clorsulon was 60 days.
Če upoštevamo podatke o izločanju ostankov iz študij, je 60 dni prva točka, pri kateri vrednosti ne presežejo ravni MRL za klorsulon.
For the purposes of this referral, that means that the withdrawal periods for all products in a single formulation group should be the same.
Za namene tega napotitvenega postopka to pomeni, da bi morale biti karence enake za vsa zdravila v posamezni formulacijski skupini.
Because the equivalence of local residue levels at the injection site cannot be predicted based on plasma bioequivalence, and because published data indicate that formulation can have an impact on residue depletion profiles for ivermectin, the CVMP considered that, in general, there is no basis for automatically extrapolating a withdrawal period established for one formulation to a second formulation, even if plasma bioequivalence has been shown.
Ker ekvivalence lokalnih ravni zaostankov na mestu injiciranja ni mogoče predvideti na podlagi plazemske bioekvivalence in ker objavljeni podatki kažejo, da ima lahko formulacija vpliv na profile izločanja ostankov ivermektina, je CVMP ugotovil, da na splošno kljub dokazani plazemski bioekvivalenci ni podlage za samodejno ekstrapolacijo karence, ki je ugotovljena pri eni formulaciji, na drugo formulacijo.
It should be noted that for many of the studies the scatter of the data was such that the harmonised statistical method for the establishment of withdrawal periods could not be used, and the withdrawal period that results from use of the alternative method is always highly dependent on the choice of time points.
Upoštevati je potrebno, da je bila za večino študij razpršenost podatkov tolikšna, da ni bilo mogoče uporabiti usklajene statistične metode za določitev karence ter da je karenca, ki se izračuna z alternativno metodo, vedno zelo odvisna od izbire časovnih točk.
ANTIBIOTICE IASI S.A. Str. Valea Lupului, nr. 1, Iaşi, jud.
Str. Valea Lupului, nr. 1, Iaşi, jud.
Additionally, for a further 11 products for which residue depletion data were provided, it was concluded that no individual withdrawal period could be calculated due to the inadequacy of the submitted product-specific data.
Poleg tega je za dodatnih 11 zdravil, za katera so bili predloženi podatki o izločanju ostankov, zaključil, da zaradi nezadostnosti predloženih podatkov, ki so specifični za to zdravilo, posameznih karenc ni mogoče izračunati.
When the alternative approach was used for individual residue study data the withdrawal period was derived from the first time point at which all calculated intakes were below the ADI, with the addition of a safety span.
Če se je uporabil alternativni pristop za podatke posameznih študij zaostankov, so karenco izpeljali iz prve časovne točke, v kateri so bili vsi izračunani vnosi pod ADI po dodatku varnostnega faktorja.
The CVMP considers that products that are essentially the same (in formulation terms) should have identical withdrawal periods.
CVMP ugotavlja, da bi morala imeti bistveno enaka zdravila (v smislu formulacije) enako karenco.
In the figure below, all available data for the total intake of ivermectin residues is plotted and compared to the ADI.
Spodnja slika prikazuje vse razpoložljive podatke o skupnem vnosu ostankov ivermektina v primerjavi z ADI.
HEMOFARM - HEMOVET Beogradski Put BB Vrsac
Romunija HEMOFARM - HEMOVET Beogradski Put BB
Belgium MERIAL Belgium S.A. Bld Sylvain Dupuis 243
Luksemburg MERIAL Belgium S.A. Bld Sylvain Dupuis 243
Moreover, because of the fact that the variation in the residue profile due to sources of variation connected to the subcutaneous use of ivermectin is much greater than the formulation effect, the Committee concluded that it would be appropriate to consider the totality of ivermectin residue data from all formulation groups to derive a single harmonised withdrawal period.
Ker je variacija profilov ostankov zaradi virov variacije, ki so povezani s podkožno uporabo ivermektina, veliko večja od učinka formulacije, je Odbor zaključil, da bi bilo primerno upoštevati skupne podatke o ostankih ivermektina iz vseh formulacijskih skupin za izpeljavo enotne usklajene karence.
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE LABELLING
DOPOLNILA, KI SE VKLJUČIJO V USTREZNA POGLAVJA OZNAČEVANJA
VET4VET d.o.o.
Slovenija VET4VET d.o.o.
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODIL ZA UPORABO
Discussion of specific issues raised in the referral notification
Razprava o specifičnih vprašanjih, zastavljenih med prijavo napotitvega postopka
VMD Animal Health Ltd. Közraktár u. 22/b.
Madžarska VMD Animal Health Ltd. Közraktár u. 22/b.
Of the formulation groups to which products were allocated in this procedure, two contained combination products; one with products containing the active substances ivermectin and clorsulon, and the second with products containing the active substances ivermectin and closantel.
Kombinirana zdravila so bila v dveh formulacijskih skupinah, v katere so bila zdravila razporejena v okviru tega postopka; v eni skupini so bila zdravila z zdravilnima učinkovinama ivermektin in klorsulon, v drugi skupini pa zdravila z zdravilnima učinkovinama ivermektin in klosantel.
the CVMP has recommended the amendment of the Marketing Authorisations for all injectable veterinary medicinal products containing ivermectin for use in cattle as refered in Annex I for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III.
CVMP priporoča dopolnilo dovoljenj za promet za vsa v Dodatku I navedena zdravila za injiciranje, ki vsebujejo ivermektin in se uporabljajo pri govedu ter imajo v Dodatku III opredeljene povzetek glavnih značilnosti zdravila, označevanje in navodila za uporabo.
A toxicological Acceptable Daily Intake (ADI) of 10 µg/kg bw/day (600 µg/person per day) was established based on the NOEL of 0.5 mg/kg bw/day retained from a 14-week dog study, applying a safety factor of 50.
Na podlagi odmerka brez opaznega učinka (NOEL) 0,5 mg/kg TM/dan, ugotovljenega v 14-tedenski študiji na psih, je bil z uporabo varnostnega faktorja 50 določen toksikološko sprejemljiv dnevni vnos (ADI) 10 µg/kg TM/dan (600 µg/osebo dnevno).
2.1 Calculation of a harmonised withdrawal period for ivermectin containing injectable products for use in cattle
2.1 Izračun usklajene karence za zdravila za injiciranje, ki vsebujejo ivermektin, za uporabo pri govedu
Based on the 11 ivermectin residue depletion studies of adequate quality provided, the CVMP calculated the withdrawal periods for 12 products.
CVMP je na podlagi 11 predloženih študij izločanja ostankov ivermektina z zadostno kakovostjo izračunal karence za 12 zdravil.
B. For products listed in Annex I containing ivermectin as sole active ingredient or in combination with closantel:
B. Za zdravila iz Dodatka I, ki vsebujejo ivermektin kot edino zdravilno učinkovino ali v kombinaciji s klosantelom:
An attempt was made to find a correlation between the slopes or intercepts of the depletion curves and any of the following parameters: formulation group, bodyweight, breed, sex, age, and injection volume, using ANOVA or Pearson's methodology.
Z metodologijo ANOVA in Pearsonovo metodo so poskusili najti korelacijo med nakloni ali presečišči krivulj izločanja in katerim koli izmed naslednjih parametrov: formulacijsko skupino, telesno maso, pasmo, spolom, starostjo in injiciranim volumnom.
Therefore, a withdrawal period of at least 49 days will apply for the combination products in all cases.
Zato imajo kombinacijska zdravila v vseh primerih karenco najmanj 49 dni.
• the CVMP considered that, taking into account the high variation observed, a single harmonised withdrawal period based on all available residue intake data should be established for all products concerned that contain ivermectin as the only active substance;
• CVMP je ob upoštevanju ugotovljene velike variacije menil, da je potrebno na podlagi vseh razpoložljivih podatkov o vnosu ostankov določiti enotno, usklajeno karenco za vsa zadevna zdravila, ki vsebujejo ivermektin kot edino zdravilno učinkovino.
Pharmacologically active substance
Farmakološka zdravilna učinkovina
Ganzestaartsedijk 8 - 5525 KC Duizel
Romunija PANTEX Ganzestaartsedijk 8 - 5525 KC Duizel The Netherlands
A safety span of 10% was considered appropriate as the studies were large and robust.
Ker so bile študije velike in robustne, se je za primernega štel 10-odstotni varnostni faktor.
Bayer Hungária Ltd. H-1123 Budapest Alkotás u. 50.
Madžarska Bayer Hungária Ltd. H-1123 Budapest
The harmonised withdrawal period of 49 days is relevant only to the ivermectin component of injectable products containing ivermectin.
Usklajena karenca v trajanju 49 dni velja le za ivermektinsko komponento zdravil za injiciranje.
Therefore, the Committee concluded that a harmonised withdrawal period of 49 days could be established for the ivermectin component of all injectable products containing ivermectin, for use in cattle.
Zato je Odbor zaključil, da se lahko za ivermektinsko komponento vseh zdravil za injiciranje z ivermektinom, ki se uporabljajo za govedo, določi usklajena karenca 49 dni.
Approach towards harmonisation of withdrawal periods http://www.emea.europa.eu/pdfs/vet/swp/003695en.pdf 2 CVMP Guideline on Injection Site Residues.
Pristop k usklajevanju karenc http://www.emea.europa.eu/pdfs/vet/swp/003695en.pdf
Box 78,
Mogilska 80,
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS
DOPOLNILA, KI SE VKLJUČIJO V USTREZNA POGLAVJA POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA
Czech Republic Bremer Pharma GmbH Cherbourger Str. 25
Romunija Bremer Pharma GmbH Cherbourger Str. 25
Calier Portugal S.A Centro Empresarial Sintra-Estoril II, Ed. C, R. Pé de Mouro Estrada de Albarraque 2710 - 335 Sintra Portugal
Portugalska Calier Portugal S.A Centro Empresarial Sintra-Estoril II, Ed. C, R. Pé de Mouro
Invented name Strengths
Izmišljeno ime
Cattle: Meat and offal - 66 days.
Govedo: Meso in drobovina - 66 dni.
Since the withdrawal period calculated based on the clorsulon component for these product exceeds the 49 days derived for the ivermectin component, 66 days is recommended as the withdrawal period for the combination products containing ivermectin and clorsulon.
Ker karenca, izračunana za klorsulonsko komponento teh zdravil, presega 49-dnevno karenco, izpeljano za ivermektinsko komponento, se za kombinirana zdravila z ivermektinom in klorsulonom določa karenca 66 dni.
ANNEX III AMENDMENT TO THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
DODATEK III DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODIL ZA UPORABO
AV Maria Lamas, Lote 19 - BL - A Piso 2 Parque Industrial Comercial Serra das Minas
Portugalska Merial Portuguesa - Saúde Animal, Lda AV Maria Lamas, Lote 19 - BL - A Piso 2 Parque Industrial Comercial Serra das Minas 2635-432 Rio de Mouro
BIOVET JSC 39 Petar Rakov Str. 4550 Pesthera Bulgaria
Bolgarija BIOVET JSC 39 Petar Rakov Str.
Alfasan International B.V., P.O.
Bolgarija Alfasan International B.V., P.O. Box 78,
For injectable veterinary medicinal products containing ivermectin in combination with another active substance residue depletion of the second active substance must also be considered, and a withdrawal period for the second active substance derived.
Pri zdravilih za injiciranje z ivermektinom v kombinaciji z drugo zdravilno učinkovino je potrebno upoštevati tudi izločanje zaostankov druge zdravilne učinkovine.
Marker residue Animal species MRLs
Živalska vrsta MRL Ciljna tkiva
If the withdrawal period determined on the basis of residue depletion data for the second active substance is less than 49 days, then a withdrawal period of 49 days is recommended for the product.
Če je karenca, določena na osnovi podatkov izločanja ostankov druge zdravilne učinkovine, krajša od 49 dni, se za zdravilo določi karenca v trajanju 49 dni.
A. For products listed in Annex I containing ivermectin and clorsulon as active ingredients: 4.11 Withdrawal period(s)
A. Za zdravila iz Dodatka I, ki kot zdravilni učinkovini vsebujejo ivermektin in klorsulon: 4.11 Karenca(-e)
• the CVMP considered that for combination products containing ivermectin as well as a second active substance, residue depletion of the second active substance must also be considered when setting the withdrawal period and the withdrawal period for the product shall be the longest established for the individual components.
• CVMP je menil, da je treba pri določanju karence za kombinirana zdravila z ivermektinom in drugo zdravilno učinkovino upoštevati tudi izločanje ostankov druge zdravilne učinkovine in da je karenca za zdravilo daljša karenca, določena za posamezni komponenti.
Cattle, Sheep, Goats, Pigs
Govedo, ovce, koze, prašiči
Closiver Injection Ivermectin 5 mg/ml, Closantel 125 mg/ml
Closiver Injection Ivermektin 5 mg/ml, klosantel 125 mg/ml
A. For products listed in Annex I containing ivermectin and clorsulon as active ingredients: 10.
A. Za zdravila iz Dodatka I, ki kot zdravilni učinkovini vsebujejo ivermektin in klorsulon: 10.
Since this is below the 49 days limit applied for the ivermectin component, a withdrawal period of 49 days is recommended for the combination products containing ivermectin and closantel.
Ker je ta karenca krajša od mejnih 49 dni za ivermektinsko komponento, se za kombinirana zdravila z ivermektinom in klosantelom določa karenca 49 dni.
WITHDRAWAL PERIOD
Označevalec ostanka
A safety span of 30% was used in view of the large variation in the intake figures, which was primarily caused by the variation of residues found in injection sites.
Zaradi velike variacije vrednosti vnosa, ki je bila zlasti posledica variacije zaostankov na mestih injiciranja, so uporabili varnostni faktor 30 %.
DUTCH FARM VETERINARY PHARMACEUTICALS B.V.
Romunija DUTCH FARM VETERINARY PHARMACEUTICALS
If, on the other hand, the withdrawal period determined on the basis of residue depletion data for the second active substance is greater than 49 days, then the recommended withdrawal period for the product should be based on depletion of residues of the second active substance.
Če pa je karenca, določena na osnovi podatkov izločanja ostankov druge zdravilne učinkovine, daljša od 49 dni, se za zdravilo določi karenca na osnovi izločanja ostankov druge zdravilne učinkovine.
Ivermectin 5 mg/ml, Closantel 125 mg/ml
Ivermektin 5 mg/ml, klosantel 125 mg/ml
Mogilska 80, 31546 Krakow Poland
31546 Krakow
2.2 Derivation of the withdrawal period for injectable veterinary medicinal products contains ivermectin as well as a second active substance (combination products)
2.2 Izpeljava karence za zdravila v veterinarski medicini za injiciranje z ivermektinom ter drugo zdravilno učinkovino (kombinacijska zdravila)
The Netherlands Dopharma Research B.V. Zalmweg 24
Nizozemska Dopharma Research B.V.
A. For products listed in Annex I containing ivermectin and clorsulon as active ingredients:
A. Za zdravila iz Dodatka I, ki kot zdravilni učinkovini vsebujejo ivermektin in klorsulon:
DAR AL DAWA VETERINARY & AGRICULTURAL INDUSTRIAL Co. LTD.
Romunija DAR AL DAWA VETERINARY & AGRICULTURAL INDUSTRIAL Co. LTD. Jordan NA UR 11710 PO BOX 285
Other sources of variation connected to the subcutaneous use of ivermectin were therefore considered to be of more importance than formulation with regard to residue depletion and withdrawal periods.
Zato so glede izločanja zaostankov in karenc kot pomembnejše od formulacije šteli druge vire variacije, povezane s podkožno uporabo ivermektina.
INDUSTRIAL VETERINARIA, S.A.
Romunija FARMAVET S.A.
WITHDRAWAL PERIOD Cattle: Meat and offal - 66 days.
KARENCA Govedo: Meso in drobovina - 66 dni.
The Netherlands Chanelle Animal Health Ltd 7 Rodney Street
Nizozemska Chanelle Animal Health Ltd 7 Rodney Street
WITHDRAWAL PERIOD Cattle: Meat and offal - 49 days
Govedo: Meso in drobovina - 49 dni
Cattle, Sheep, Reindeer, Pigs
Govedo, ovce, jeleni, prašiči
Baymec Trio 1% Ivermectin 10 mg/ml
Baymec Trio 1% Ivermektin 10 mg/ml
United Kingdom Chanelle Animal Health Ltd 7 Rodney Street
Portugalska Chanelle Animal Health Ltd 7 Rodney Street
United Kingdom VIRBAC DE PORTUGAL Laboratorios LdaRua Dionísio Saraiva, Lote 1,
Portugalska VIRBAC DE PORTUGAL Laboratorios Lda Rua Dionísio Saraiva, Lote 1,
Belgium Laboratorios Calier SA Barcelones
Madžarska Laboratorios Calier SA Barcelones
Cattle, Reindeer, Pigs
Govedo, jeleni, prašiči
Wedemec R Ivermectin 10 mg/ml
Wedemec R Ivermektin 10 mg/ml
BOVIMEC B Ivermectin 10 mg/ml
BOVIMEC B Ivermektin 10 mg/ml
Diapec R Ivermectin 10 mg/ml
Diapec R Ivermektin 10 mg/ml
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET
DOPOLNILA, KI SE VKLJUČIJO V USTREZNA POGLAVJA NAVODIL ZA UPORABO
Slovak Republic MERIAL 29 avenue Tony Garnier 69007 LYON
Slovenija MERIAL 29 avenue Tony Garnier 69007 LYON France
WITHDRAWAL PERIOD Cattle: Meat and offal - 49 days.
KARENCA Govedo: Meso in drobovina - 49 dni.
Subcutaneous Cattle, Sheep, Goats: 200 μg ivermectin/kg bw
Subkutana Govedo, ovce, koze: 200 μg ivermektina/kg TM
FROMMECTIN Ivermectin 10 mg/ml
FROMMECTIN Ivermektin 10 mg/ml
MAXIMEC Ivermectin 10 mg/ml
MAXIMEC Ivermektin 10 mg/ml
Subcutaneous 200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw
Subkutana 200 μg ivermektina/kg TM, 2 mg klorsulona/kg TM
The Netherlands Cross Vetpharm Group Ltd, Broomhill Road
Nizozemska Cross Vetpharm Group Ltd, Broomhill Road
PROMECTINE Ivermectin 10 mg/ml
PROMECTINE Ivermektin 10 mg/ml
VETERMEC Ivermectin 10 mg/ml
VETERMEC Ivermektin 10 mg/ml
VALANEQ Ivermectin 10 mg/ml
VALANEQ Ivermektin 10 mg/ml
Ivotan LA Ivermectin 10 mg/ml
Ivotan LA Ivermektin 10 mg/ml
TIZOVAL Ivermectin 10 mg/ml
TIZOVAL Ivermektin 10 mg/ml
ECOMECTIN Ivermectin 10 mg/ml
ECOMECTIN Ivermektin 10 mg/ml
Czech Republic MERIAL 29 avenue Tony Garnier 69007 LYON
Romunija MERIAL 29 avenue Tony Garnier 69007 LYON France
Ivermektin S Ivermectin 10 mg/ml
Ivermektin S Ivermektin 10 mg/ml
Euromec Injectie Ivermectin 10 mg/ml
Euromec Injectie Ivermektin 10 mg/ml
Enovex Injection Ivermectin 10 mg/ml
Enovex Injection Ivermektin 10 mg/ml
Paramectin 1% Ivermectin 10 mg/ml
Paramectin 1% Ivermektin 10 mg/ml
Maximec Injectie Ivermectin 10 mg/ml
Maximec Injectie Ivermektin 10 mg/ml
IVERTIN Ivermectin 10 mg/ml
IVERTIN Ivermektin 10 mg/ml
Subcutaneous 200 μg ivermectin/kg bw, 5 mg closantel/kg bw
Subkutana 200 μg ivermektina/kg TM, 5 mg klosantela/kg TM
Subcutaneous Cattle, Sheep, Reindeer: 200 μg ivermectin/kg bw
Subkutana Govedo, ovce, jeleni: 200 μg ivermektina/kg TM
BOVECTIN Ivermectin 10 mg/ml
BOVECTIN Ivermektin 10 mg/ml
VIRBAMEC Ivermectin 10 mg/ml
VIRBAMEC Ivermektin 10 mg/ml
Ivermectin 10 mg/ml, Clorsulon 100 mg/ml
Ivermektin 10 mg/ml, klorsulon 100 mg/ml
BIMECTIN Ivermectin 10 mg/ml
BIMECTIN Ivermektin 10 mg/ml
Anisec Injection Ivermectin 10 mg/ml
Anisec Injection Ivermektin 10 mg/ml
United Kingdom Cross Vetpharm Group Ltd, Broomhill Road
Portugalska Cross Vetpharm Group Ltd, Broomhill Road
Alfamec 1 % Ivermectin 10 mg/ml
Alfamec 1 % Ivermektin 10 mg/ml
The withdrawal period for the product will be the longer of the withdrawal periods derived for the individual components.
Karenca za zdravilo je enaka daljši vrednosti od obeh karenc, sicer ugotovljeni za posamezni komponenti.
Ivomec 1% Ivermectin 10 mg/ml
Ivomec 1% Ivermektin 10 mg/ml
Biomectin 1% Ivermectin 10 mg/ml
Biomectin 1 % Ivermektin 10 mg/ml
Biomectin 1 % Ivermectin 10 mg/ml
Biomectin 1% Ivermektin 10 mg/ml
Iverktin Injection Ivermectin 10 mg/ml
Iverktin Injection Ivermektin 10 mg/ml
Virbamec F Ivermectin 10 mg/ml, Clorsulon 100 mg/ml
Virbamec F Ivermektin 10 mg/ml, klorsulon 100 mg/ml
Pandex 1% Ivermectin 10 mg/ml
Pandex 1% Ivermektin 10 mg/ml
The Netherlands Laboratorios Calier SA Barcelones
Nizozemska Laboratorios Calier SA Barcelones
IVOMEC F Ivermectin 10 mg/ml, Clorsulon 100 mg/ml
IVOMEC F Ivermektin 10 mg/ml, klorsulon 100 mg/ml
IVOMEC D Ivermectin 10 mg/ml, Clorsulon 100 mg/ml
IVOMEC D Ivermektin 10 mg/ml, klorsulon 100 mg/ml
Animec Injection Ivermectin 10 mg/ml
Animec Injection Ivermektin 10 mg/ml
Sumiject Injection Ivermectin 10 mg/ml
Sumiject Injection Ivermektin 10 mg/ml
Cevamec 1% Ivermectin 10 mg/ml
Cevamec 1% Ivermektin 10 mg/ml
Aniject Injection Ivermectin 10 mg/ml
Aniject Injection Ivermektin 10 mg/ml
Topimec Injection Ivermectin 10 mg/ml
Topimec Injection Ivermektin 10 mg/ml
Ecomectin 1% Ivermectin 10 mg/ml
Ecomectin 1 % Ivermektin 10 mg/ml
Ecomectin 1 % Ivermectin 10 mg/ml
Ecomectin 1% Ivermektin 10 mg/ml
Ivermectina 1% Ivermectin 10 mg/ml
Ivermectina 1% Ivermektin 10 mg/ml
Subcutaneous Cattle, Reindeer: 200 μg ivermectin/kg bw
Subkutana Govedo: 200 μg ivermektina/kg TM
Bimectin Injectie Ivermectin 10 mg/ml
Bimectin Injectie Ivermektin 10 mg/ml
Ivodad 1% Ivermectin 10 mg/ml
Ivodad 1% Ivermektin 10 mg/ml
Belgium Norbrook Laboratories Limited Station Works
Portugalska Norbrook Laboratories Limited Station Works
The Netherlands ECO Animal Health Ltd 78 Coombe Road
Nizozemska ECO Animal Health Ltd 78 Coombe Road
Belgium ECO Animal Health Ltd 78 Coombe Road
Bolgarija ECO Animal Health Ltd 78 Coombe Road
IVERVETo 1 % Ivermectin 10 mg/ml
IVERVETo 1 % Ivermektin 10 mg/ml
Av.Los Cerrilos 602 Santiago,
Bolgarija Centrovet Ltd. Av.Los Cerrilos 602
Czech Republic ECO Animal Health Ltd 78 Coombe Road
Madžarska ECO Animal Health Ltd 78 Coombe Road
The Netherlands Norbrook Laboratories Limited Station Works
Nizozemska Norbrook Laboratories Limited Station Works
United Kingdom ECO Animal Health Ltd 78 Coombe Road
Romunija ECO Animal Health Ltd 78 Coombe Road
Jylamvo received a marketing authorisation valid throughout the EU on 29 March 2017.
Za zdravilo Jylamvo je bilo 29. marca 2017 izdano dovoljenje za promet, veljavno po vsej EU.
For inflammatory conditions it is taken once a week, on the same day each week.
Pri uporabi za vnetna stanja se jemlje enkrat tedensko, vedno na isti dan v tednu.
This especially affects fast-growing cells such as cancer cells.
To še zlasti vpliva na hitro rastoče celice, kot na primer rakave celice.
The doctor may check with the patient or the patient's carer that the medicine can reliably be taken once a week.
Zdravnik lahko pri bolniku ali njegovem skrbniku preveri, da se zdravilo zanesljivo jemlje enkrat tedensko.
Further information on Jylamvo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/jylamvo.
Nadaljnje informacije za zdravilo Jylamvo so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/jylamvo.
What measures are being taken to ensure the safe and effective use of Jylamvo?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Jylamvo?
How often methotrexate is given depends on the other medicines it is used with.
Pogostost dajanja metotreksata je odvisna od drugih zdravil, s katerimi se uporablja.
The company provided data from the published literature on the benefits and risks of methotrexate in the approved uses.
Podjetje je predstavilo podatke iz objavljene literature o koristih in tveganjih metotreksata pri odobrenih uporabah.
It should be prescribed only by doctors with expertise in the use of methotrexate and a full understanding of the risks of methotrexate treatment.
Predpisovati bi ga morali le zdravniki s strokovnim znanjem na področju uporabe metotreksata in popolnim razumevanjem tveganj zdravljenja z metotreksatom.
Jylamvo (methotrexate)
Jylamvo (metotreksat)
What benefits of Jylamvo have been shown in studies?
Kakšne koristi zdravila Jylamvo so se pokazale v študijah?
An overview of Jylamvo and why it is authorised in the EU
Pregled zdravila Jylamvo in zakaj je odobreno v EU
In most cases, methotrexate medicines are used for long-term treatment.
V večini primerov se zdravila, ki vsebujejo metotreksat, uporabljajo za dolgotrajno zdravljenje.