natgillin/translations-raw huggingface dataset:
The benefit-risk evaluation for the products concerned is deemed to be positive provided that (i) for the injectable products the withdrawal periods for meat and offal are set for cattle at 70 days, for sheep at 70 days, for pigs at 77 days and for reindeer at 70 days, (ii) for the injectable and pour-on products the following periods with regard to milk are set as the minimum time spans that must elapse between treatment and calving/lambing: 2 months for cattle and reindeer and 70 days for sheep and (iii) for the injectable and pour-on products risk mitigation measures are added to the product information regarding risk to aquatic organisms and dung fauna.
Ocena razmerja med tveganji in koristmi za zadevna zdravila velja za pozitivno pod pogojem, (i) da se za zdravila za injiciranje določijo karence za meso in drobovino, in sicer 70 dni za govedo, 70 dni za ovce, 77 dni za prašiče in 70 dni za jelenjad, (ii) da se za zdravila za injiciranje in kožni poliv določijo naslednja obdobja glede mleka, ki predstavljajo minimalni časovni razpon, ki mora preteči med zdravljenjem in otelitvijo/jagnjitvijo: 2 meseca za govedo in jelenjad ter 70 dni za ovce in (iii) da se za zdravila za injiciranje in kožni poliv v informacije o zdravilu vključijo ukrepi za zmanjševanje tveganja v zvezi s tveganjem za vodne organizme in organizme, prisotne v gnoju.
Furthermore the evaluation concludes that use of injectable and pour-on veterinary medicinal products containing doramectin during the nonlactating period could lead to residue levels in milk resulting in consumer exposure over the acceptable daily intake.
Nadalje je bilo v okviru ocene zaključeno, da lahko uporaba zdravil za injiciranje in kožni poliv za uporabo v veterinarski medicini, ki vsebujejo doramektin, med obdobjem izven laktacije vodi do ravni ostankov v mleku, ki povzročajo izpostavljenost potrošnika, ki je večja od največjega dovoljenega dnevnega vnosa.
Animal species
Pot uporabe Živalska vrsta
The MRLs currently established for doramectin in tissues use 90% (60 μg/person per day) of the ADI, leaving 10% (6 μg) available to cover exposure to residues resulting from other sources, such as via milk.
Mleko − časovni razpon med zdravljenjem živali izven časa laktacije in otelitvijo: Trenutno sprejeta mejna vrednost ostankov za doramektin v tkivih predstavlja 90 % (60 μg/osebo na dan) največjega dovoljenega dnevnega vnosa, kar pomeni, da ostane 10 % (6 μg) za izpostavljenost ostankom iz drugih virov, na primer prek mleka.
Scientific conclusions and grounds for amendment of the summaries of product characteristics, labelling and package leaflets
Znanstveni zaključki in podlaga za dopolnilo povzetkov glavnih značilnosti zdravila, označevanja in navodil za uporabo
• On the basis of the environmental risk assessment data submitted by the applicants/marketing authorisation holders for the injectable and pour-on veterinary medicinal products containing doramectin, the CVMP considered that in order to address the identified risks for aquatic organisms and dung fauna, as well as any remaining uncertainty regarding bioaccumulation, risk mitigation measure should be applied;
• na osnovi podatkov o oceni tveganja za okolje, ki so jih predložili predlagatelji oz. imetniki dovoljenj za promet za zdravila za uporabo za injiciranje in kožni poliv v veterinarski medicini, ki vsebujejo doramektin, je CVMP menil, da je treba za obravnavo opredeljenih tveganj za vodne organizme in organizme, prisotne v gnoju, ter morebitnih preostalih negotovosti v zvezi z biološkim kopičenjem, vzpostaviti ukrepe za zmanjšanje tveganja;
UNITED KINGDOM
Združeno Kraljestvo
Reindeer
Jelenjad
Other precautions
Druga opozorila
However, two non-GLP residue depletion studies performed in lactating cattle were available and provided data on residues in milk.
Na voljo sta bili dve študiji brez dobre laboratorijske prakse o izločanju ostankov pri govedu v laktaciji in predloženi so bili podatki o ostankih v mleku.
Not permitted for use in lactating animals producing milk for human consumption.
Zdravila se ne sme uporabljati pri živalih v laktaciji katerih mleko se uporablja v prehrani ljudi.
Alkotás u. 53.
Madžarska Pfizer Kft. Alkotás u. 53.
Cattle, sheep
Govedo, ovce
Cattle, reindeer, pigs
Govedo, jelen, prašiči
Injectable veterinary medicinal product containing doramectin
Zdravila za uporabo v veterinarski medicini za injiciranje, ki vsebujejo doramektin Govedo
In addition, the Netherlands noted that injectable and pour-on veterinary medicinal products containing doramectin intended for food producing species contain different risk mitigation measures in the product information in relation to the risks for the environment.
Poleg tega je Nizozemska opozorila, da so v informacijah o zdravilih za uporabo v veterinarski medicini za injiciranje ali kožni poliv, ki vsebujejo doramektin in so namenjena uporabi pri vrstah, namenjenih za človeško prehrano, navedeni drugačni ukrepi za zmanjšanje tveganja v zvezi s tveganji za okolje.
Doramectin is very toxic to aquatic organisms and may accumulate in sediments.
Doramektin je zelo strupen za vodne organizme in se lahko kopiči v sedimentih.
A withdrawal period of 77 days is therefore recommended for pig meat and offal.
Za prašičje meso in organe je zato priporočena karenca 77 dni.
Reindeer:
Jelen:
No milk residue data following treatment of dairy animals in the dry period were available to the CVMP.
CVMP ni prejel nobenih podatkov o ostankih v mleku po zdravljenju živali molznic v presušitvi.
Cattle, sheep, reindeer
Govedo, ovce, jelen
In order to address the identified risks for aquatic organisms and dung fauna as well as any remaining uncertainty regarding bioaccumulation the following risk mitigation measures are recommended for the injectable veterinary medicinal products containing doramectin:
Za obravnavo opredeljenih tveganj za vodne organizme in organizme, prisotne v gnoju, ter morebitnih preostalih negotovosti v zvezi z biološkim kopičenjem, se priporočajo naslednji ukrepi za zmanjševanje tveganja za zdravila za injiciranje, ki vsebujejo doramektin:
• On the basis of the residue depletion data in cattle and sheep submitted by the applicants/marketing authorisation holders for the injectable veterinary medicinal products containing doramectin, and in the absence of maximum residue limits for doramectin in milk, the CVMP considered the minimum time spans of 2 months for cattle and reindeer and 70 days for sheep must elapse between administration of these doramectin containing products and calving or lambing;
• na osnovi podatkov o izločanju ostankov pri govedu in ovcah, ki so jih predložili predlagatelji oz. imetniki dovoljenj za promet za zdravila za uporabo za injiciranje v veterinarski medicini, ki vsebujejo doramektin, in ob odsotnosti najvišjih dovoljenih količin ostankov za doramektin v mleku je CVMP menil, da je minimalni časovni razpon, ki mora preteči med dajanjem teh zdravil z doramektinom in otelitvijo ali jagnjitvijo, 2 meseca za govedo in jelenjad ter 70 dni za ovce;
In order to address the identified risks for aquatic organisms and dung fauna as well as any remaining uncertainty regarding bioaccumulation the following risk mitigation measures are recommended for the pour-on veterinary medicinal products containing doramectin:
Za obravnavo opredeljenih tveganj za vodne organizme in organizme, prisotne v gnoju, ter morebitnih preostalih negotovosti v zvezi z biološkim kopičenjem, se priporočajo naslednji ukrepi za zmanjševanje tveganja za zdravila za kožni poliv, ki vsebujejo doramektin:
The injection site was consistently the tissue in which the marker residue persisted for longest and was consequently the key tissue for the withdrawal period derivation.
Mesto injiciranja je bilo vedno tkivo, v katerem se je ostanek označevalca ohranil najdlje, zato je bilo to ključno tkivo za izračun karence.
Dectomax-S Injektionslösung intramuscular Pigs
Dectomax-S Injektionslösung intramuskularno Prašiči
Doramectin is very toxic to dung fauna and aquatic organisms and may accumulate in sediments.
Doramektin je zelo strupen za organizme, prisotne v gnoju ter vodne organizme in se lahko akumulira v sedimentih.
The Committee therefore calculated a minimum time spans of 2 months for cattle and reindeer and 70 days for sheep that should elapse between administration of these doramectin containing products and calving or lambing.
Odbor je zato izračunal minimalni časovni razpon, ki mora preteči med dajanjem teh zdravil z doramektinom in otelitvijo ali jagnjitvijo, in sicer 2 meseca za govedo in jelenjad ter 70 dni za ovce.
One GLP residue depletion study in non-lactating sheep was available for evaluation by the CVMP, as well as two published studies in lactating sheep.
CVMP je imel na voljo za vrednotenje eno študijo dobre laboratorijske prakse o izločanju ostankov pri ovcah izven časa laktacije in dve objavljeni študiji pri ovcah v laktaciji.
In addition, in cattle doramectin is administered topically on the back of the animal at a dose of 500 μg/kg bw for treatment of infestations of gastrointestinal roundworms, lungworms, eyeworms, warbles, sucking and biting lice, mange mites and hornfly.
Poleg tega se pri govedu doramektin uporablja topikalno na hrbtu živali v odmerku 500 μg/kg telesne mase za zdravljenje infestacij želodčno-črevesnih glist, pljučnih črvov, očesnih črvov, govejih zoljev, sesajočih uši, perojedi, garij in muhe Haematobia irritans.
• On the basis of the residue depletion data in cattle, sheep, pigs and reindeer submitted by the applicants/marketing authorisation holders for the injectable veterinary medicinal products containing doramectin, the CVMP considered that withdrawal periods of 70 days for cattle meat and offal, 70 days for sheep meat and offal, 77 days for pig meat and offal and 70 days for reindeer meat and offal were safe;
• na osnovi podatkov o izločanju ostankov pri govedu, ovcah, prašičih in jelenjadi, ki so jih predložili predlagatelji oz. imetniki dovoljenj za promet za zdravila za injiciranje za uporabo v veterinarski medicini, ki vsebujejo doramektin, je CVMP menil, da so varne karence 70 dni za goveje meso in organe, 70 dni za ovčje meso in organe, 77 dni za prašičje meso in organe ter 70 dni za jelenje meso in organe;
Meat and offal:
Meso in organi:
Zearl 10 mg/ml Solution for Injection for Pigs intramuscular Pigs
Zearl 10 mg/ml Solution for Injection for Pigs intramuskularno Prašiči
The risk to aquatic ecosystems and dung fauna can be reduced by avoiding too frequent and repeated use of doramectin (and products of the same anthelmintic class) in cattle and sheep.
Tveganje za vodne ekosisteme in organizme, prisotne v gnoju, je mogoče zmanjšati z izogibanjem prepogosti in ponovni uporabi doramektina (in zdravil iz istega razreda antihelmintikov) pri govedu in ovcah.
(EMA/CVMP/VICH/463199/2009)1 which indicates that quality control measures should be introduced to ensure that the injection site is appropriately sampled, for example by collection of separate core and surrounding samples, which is the methodology recommended in the CVMP guideline on injection site residues (EMEA/CVMP/542/03)2.
Zabeležili so, da je bila večina študij izločanja ostankov, ki jih je za vrednotenje predložil CVMP, izvedena pred uvedbo trenutnih navodil glede vzorčenja na mestu injiciranja: VICH GL48 o študijah izločanja ostankov označevalca za izračun obdobij karence zdravil (EMA/CVMP/VICH/463199/2009)1, ki navaja, da je treba uvesti ukrepe za nadzor kakovosti, s katerimi se zagotovi ustrezno vzorčenje na mestu injiciranja, na primer z zbiranjem vzorcev iz mesta injiciranja in okolice, kar je metodologija, priporočena v navodilih CVMP o ostankih na mestu injiciranja (EMEA/CVMP/542/03)2.
The injection site was the tissue in which the marker residue persisted for longest and was consequently the tissue for the withdrawal period derivation.
Mesto injiciranja je bilo tkivo, v katerem se je ostanek označevalca ohranil najdlje, zato je bilo to tkivo uporabljeno za izračun karence.
Amendments in the relevant sections of the summary of product characteristics, labelling and package leaflets
Dopolnila, ki se vključijo v ustrezna poglavja povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo
The risk to aquatic ecosystems and dung fauna can be reduced by avoiding too frequent and repeated use of doramectin (and products of the same anthelmintic class) in cattle.
Tveganje za vodne ekosisteme in organizme, prisotne v gnoju, je mogoče zmanjšati z izogibanjem prepogosti in ponovni uporabi doramektina (in zdravil iz istega razreda antihelmintikov) pri govedu.
Amendments in the relevant sections of the product information for injectable veterinary medicinal products containing doramectin:
Dopolnila, ki se vključijo v ustrezna poglavja informacij o zdravilu za zdravila za uporabo v veterinarski medicini, ki vsebujejo doramektin in so za injiciranje:
Having considered the residue depletion data submitted by the applicants/marketing authorisation holders for the injectable veterinary medicinal products containing doramectin, withdrawal periods of 70 days for cattle meat and offal, 70 days for sheep meat and offal, 77 days for pig meat and offal and 70 days for reindeer meat and offal were considered safe.
Po proučitvi podatkov o izločanju ostankov, ki so jih predložili predlagatelji oz. imetniki dovoljenj za promet za zdravila za uporabo za injiciranje v veterinarski medicini, ki vsebujejo doramektin, so ocenjene varne karence 70 dni za goveje meso in organe, 70 dni za ovčje meso in organe, 77 dni za prašičje meso in organe ter 70 dni za jelenje meso in organe.
In sheep it is administered as a single intramuscular injection at a dose of 200 or 300 μg/kg bw for treatment and control of gastrointestinal roundworms, mange mites and nasal bots.
Pri ovcah se daje kot enkratna intramuskularna injekcija v odmerku 200 ali 300 μg/kg telesne mase za zdravljenje in nadzor želodčno-črevesnih glist, garij in nosnih zoljev.
Grounds for amendment of the summary of product characteristics, labelling and package leaflets
Podlaga za dopolnilo povzetka glavnih značilnosti zdravila, označevanja in navodil za uporabo
Dectomax 10 mg/ml Solution for Injection for Pigs intramuscular Pigs
Dectomax 10 mg/ml Solution for Injection for Pigs intramuskularno Prašiči
Benefit-Risk Assessment
Ocena razmerja med tveganji in koristmi
Do not use in pregnant ewes, which are intended to produce milk for human consumption, within 70 days of expected parturition.
Ne uporabljajte 70 dni pred predvidenim porodom pri brejih ovcah, katerih mleko se bo uporabljalo v prehrani ljudi.
Doramectin is administered by subcutaneous injection to cattle at a dose of 200 μg/kg body weight (bw) for the treatment and control of gastrointestinal nematodes, lungworms, eyeworms, warbles, lice, mange mites and ticks.
Doramektin se daje kot subkutana injekcija govedu v odmerku 200 μg/kg telesne mase za zdravljenje in nadzor želodčno-črevesnih nematodov, pljučnih črvov, očesnih črvov, govejih zoljev, uši, garij in klopov.
In pigs it is administered as a single intramuscular injection at a dose of 300 μg/kg bw for treatment of mange mites, gastrointestinal roundworms, lungworms, kidney worms and sucking lice.
Pri prašičih se daje kot enkratna intramuskularna injekcija v odmerku 300 μg/kg telesne mase za zdravljenje garij, želodčno-črevesnih glist, pljučnih črvov, velikanskih glist in sesajočih uši.
In reindeer doramectin is administered as a single subcutaneous injection at a dose of 200 μg/kg bw for treatment of nematodes and throat bot.
Pri jelenjadi se doramektin daje kot enkratna subkutana injekcija v odmerku 200 μg/kg telesne mase za zdravljenje nematodov in zolja Gasterophilus haemorrhoidalis.
Pour-on veterinary medicinal product containing doramectin (cattle)
Zdravila za uporabo v veterinarski medicini za kožni poliv, ki vsebujejo doramektin (govedo) Meso in organi:
Do not use in pregnant cows or heifers, which are intended to produce milk for human consumption, within 2 months of expected parturition.
Ne uporabljajte 2 meseca pred predvidenim porodom pri brejih kravah oziroma telicah, katerih mleko se bo uporabljalo v prehrani ljudi.
Amendments in the relevant sections of the product information for pour-on veterinary medicinal products containing doramectin:
Dopolnila, ki se vključijo v ustrezna poglavja informacij o zdravilu za zdravila za uporabo v veterinarski medicini, ki vsebujejo doramektin in so v obliki kožnega poliva:
The risk to aquatic ecosystems will be further reduced by keeping treated cattle away from water bodies for two to five weeks after treatment.
S tem, da zdravljenemu govedu preprečimo dostop do vodnih teles za dva do pet tednov po zdravljenju, lahko dodatno zmanjšamo nevarnost za vodne ekosisteme.
Prontax subcutaneous Cattle
Prontax subkutano
Do not use in pregnant does, which are intended to produce milk for human consumption, within 2 months of expected parturition.
Ne uporabljajte 2 meseca pred predvidenim porodom pri brejih košutah, katerih mleko se bo uporabljalo v prehrani ljudi.
According to the VICH Guideline 38 Phase II, a Tier B assessment is required.
V skladu z navodili VICH 38 za fazo II je potrebno ocenjevanje v stopnji B. V prvem primeru kljub več izboljšanjem predvidenih koncentracij v okolju (PKO) tveganja za vodne nevretenčarje pri scenariju neposrednega izločanja ni bilo mogoče izključiti.
Slovakia
Slovaška Republika
One non-GLP residue depletion study in lactating dairy cattle and two GLP residue depletion studies in non-lactating cattle were available for evaluation by the CVMP.
Mleko − časovni razpon med zdravljenjem živali izven časa laktacije in otelitvijo: CVMP je imel na voljo za vrednotenje eno študijo brez dobre laboratorijske prakse o izločanju ostankov pri kravah molznicah v laktaciji in dve študiji dobre laboratorijske prakse o izločanju ostankov pri govedu izven časa laktacije.
Package leaflet:
Navodilo za uporabo:
As indicated above 3 µg/l is considered to represent a safe level of doramectin in milk.
Mleko − časovni razpon med zdravljenjem živali izven laktacije in jagnjitvijo: Kot je navedeno zgoraj, se ocenjuje, da količina 3 µg/kg predstavlja varno raven doramektina v mleku.
A withdrawal period of 70 days is therefore recommended for reindeer meat and offal.
Za jelenje meso in organe je zato priporočena karenca 70 dni.
Packaging Content (concentration)
Vsebina (koncentracija)
This summary was last updated on 10.01.2008.
Povzetek je bil nazadnje posodobljen 10.01.2008
Page 2/2©EMEA 2008
Stran 2/2©EMEA 2008
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Če želite več informacij o podlagi za priporočila CVMP, preberite znanstveno razpravo (ki je prav tako del EPAR).
The bacterium has been inactivated (treated to make it unable to cause an illness).
Bakterija je bila inaktivirana (obdelana tako, da ne more povzročiti bolezni).
If pain persists for more than 12 hours after examination, seek medical advice again.
Če bolečina traja več kot 12 ur po zdravniškem pregledu, ponovno poiščite medicinsko pomoč.
The vaccine also contains an ‘adjuvant' (liquid paraffin) to stimulate a better response.
Cepivo vsebuje tudi adjuvans (tekoči parafin) za stimulacijo boljšega odziva.
The first injection is given at an age of six to 12 weeks and the second at least six weeks later at an age of 14 to 18 weeks.
Prva injekcija se da pri starosti šestih do 12 tednov, druga pa vsaj šest tednov pozneje pri starosti 14 do 18 tednov.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR)
Infection with O. rhinotracheale can cause respiratory diseases and death.
Okužba z O. rhinotracheale lahko povzroči bolezni dihal in smrt.
The studies also looked at the offspring (broilers).
V študijah so preučevali tudi potomce (brojlerje).
Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against diseases.
Cepiva delujejo tako, da imunski sistem (naravno obrambo telesa) „naučijo“, kako naj se brani pred boleznimi.
Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
Pojasnjuje, kako je Odbor za zdravila za uporabo v veterinarski medicini (CVMP) ocenil predloženo dokumentacijo, na podlagi česar je oblikoval priporočila glede uporabe zdravila.
Information on the prescription status of this product may be found on the label/outer package.
Informacije o predpisovanju tega zdravila najdete na nalepki/zunanji ovojnini.
Immunity is transferred to the chicken's offspring for a period of 43 weeks after the last vaccination.
Imunost se prenaša na potomce kokoši 43 tednov po zadnjem cepljenju.
The European Commission granted a marketing authorisation valid throughout the European Union for Nobilis OR Inac to Intervet International on 24 January 2003.
Evropska komisija je dovoljenje za promet z zdravilom Nobilis OR Inac, veljavno po vsej Evropski uniji, odobrila družbi Intervet International dne 24. januarja 2003.
The benefit-risk balance may be found in module 6 of this EPAR.
Razmerje med koristmi in tveganji najdete v modulu 6 tega Evropskega javnega poročila o oceni zdravila (EPAR).
In the study, the levels of antibodies were higher in the vaccinated breeders than in those that did not receive the vaccine, both at 22 and at 58 weeks of age.
V študiji so bile ravni protiteles pri cepljenih kokoših matičnih jat večje kot pri tistih, ki niso prejele cepiva, tako pri starosti 22 tednov kot 58 tednov.
The antibodies then protect the offspring against infection with this type of bacterium.
Protitelesa nato ščitijo potomce pred okužbo s to vrsto bakterije.
The effectiveness of Nobilis OR Inac has been studied in two main studies that compared the effectiveness of Nobilis OR Inac with that of no vaccination.
Učinkovitost zdravila Nobilis OR Inac so preučevali v dveh glavnih študijah, v katerih so primerjali učinkovitost zdravila Nobilis OR Inac z učinki v primeru, ko cepivo ni bilo dano.
These antibodies are then passed on to the breeder's offspring through the eggs.
Ta protitelesa se nato prenesejo na potomce teh kokoši prek jajc.
What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
Koliko časa je potrebno počakati pred zakolom in uporabo mesa za prehrano ljudi (karenca)?
The studies looked at the levels of antibodies against O. rhinotracheale in the vaccinated breeders at four weeks after the second injection of the vaccine (22 weeks of age), and again at the end of the laying period (58 weeks of age).
V študijah so preučevali ravni protiteles proti O. rhinotracheale pri cepljenih kokoših matične jate štiri tedne po drugem injiciranju cepiva (pri starosti 22 tednov) in nato ponovno ob koncu obdobja valjenja (pri starosti 58 tednov).
Nobilis OR Inac is an emulsion (a mixture of oil- and water-based liquids) for injection.
Zdravilo Nobilis OR Inac je emulzija (zmes tekočin na osnovi olja in vode) za injiciranje.
Nobilis OR Inac is given as two 0.25-ml injections, either under the skin in the neck or into the breast muscle.
Zdravilo Nobilis OR Inac se daje v obliki dveh 0,25 ml injekcij pod kožo na vratu ali v prsno mišico.
Nobilis OR Inac is used to vaccinate female chickens that are being used for breeding broilers (chickens bred for meat) against the bacterium O. rhinotracheale serotype A. This immunity is then passed on to the chickens' offspring, so that the broilers are protected against infection with the same type of bacteria.
Zdravilo Nobilis OR Inac se uporablja za cepljenje piščancev ženskega spola, ki se uporabljajo za vzrejo brojlerjev (piščancev, ki se redijo za meso) proti bakteriji O. rhinotracheale, serotipa A. Ta imunost se nato prenese na potomce cepljenih piščancev (kokoši), tako da so brojlerji zaščiteni pred okužbo z enako vrsto bakterije.
If accidental injection happens, seek prompt medical advice and show the Package Leaflet to the doctor.
V primeru nenamernega injiciranja nemudoma poiščite medicinsko pomoč in pokažite zdravniku Navodilo za uporabo.