FrancophonIA/ELRC3.0 huggingface dataset:
English: A risk has been identified regarding the length of the authorised withdrawal periods for sheep (meat and offal), which, for some products, may be insufficient to allow residues of closantel to fall below the authorised MRLs in all edible tissues by the end of the withdrawal period, thereby posing a risk to consumers of meat and offal from sheep treated with these products.
Slovenian: Prepoznano je bilo tveganje v zvezi s trajanjem odobrenih karenc pri ovcah (meso in organi), ki je pri nekaterih zdravilih morda prekratka, da bi koncentracija ostankov klozantela lahko do konca obdobja karence padla pod dovoljeno MRL v vseh tkivih, namenjenih prehrani, kar predstavlja tveganje za potrošnike, ki zaužijejo meso in organe ovac, zdravljene s temi zdravili.
English: Residue depletion in sheep meat and offal
Slovenian: Izločanje ostankov v mesu in organih ovac
English: • the data from Study 1 show that the liver is the withdrawal period determining tissue, and that the ‘alternative method', as recommended in CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95), should be used to determine the withdrawal period as the statistical assumptions are not all met when trying to use the preferred statistical analysis.
Slovenian: • podatki iz študije 1 kažejo, da so jetra tkivo, ki določa karenco, in da je treba za določitev karence uporabiti alternativno metodo, priporočeno v sporočilu odbora CVMP glede priporočil o pristopu k usklajevanju obdobij karenc (EMEA/CVMP/036/95), saj pri poskusu uporabe prednostne statistične analize niso izpolnjene statistične predpostavke.
English: In terms of sensitivity, the limit of quantification in Study 1 was determined as 150 µg/kg in muscle, whereas the limit of quantification in Study 2 was
Slovenian: Z vidika občutljivosti je bila v študiji 1 kot meja določljivosti določena koncentracija 150 µg/kg v mišicah, v študiji 2 pa je bila meja določljivosti manj občutljiva, 500 µg/kg.
English: A 41-day withdrawal period was determined, following statistical evaluation of the residues depletion data using the WT1.4 software.
Slovenian: Na podlagi statistične ocene izločanja ostankov s programsko opremo WT1.4 so določili 41-dnevno karenco.
English: 2 VICH topic GL48: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Marker-residue-depletion studies to establish product withdrawal periods (EMA/CVMP/VICH/463199/2009) https://www.ema.europa.eu/documents/scientific-guideline/vich-gl48-studies-evaluate-metabolism-residue-kineticsveterinary-drugs-food-producing-animals_en.pdf
Slovenian: 2 VICH topic GL48: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Marker-residue-depletion studies to establish product withdrawal periods (EMA/CVMP/VICH/463199/2009) https://www.ema.europa.eu/documents/scientific-guideline/vich-gl48-studies-evaluate-metabolism-residue-kineticsveterinary-drugs-food-producing-animals_en.pdf ovrednotenih v tem postopku, pa je mogoče priporočiti 107-dnevno karenco za ovce (meso in organe) za zadevna zdravila, ki vsebujejo 50 mg klozantela na ml (kot edino učinkovino), v obliki raztopine za injiciranje za subkutano uporabo pri ovcah.
English: Do not use within 1 year prior to the first lambing in ewes intended to produce milk for human consumption.
Slovenian: Pri ovcah mlekaricah, namenjenih proizvodnji mleka za prehrano ljudi, ne uporabljajte do 1 leto pred prvo kotitvijo.
English: The overall benefit-risk balance for the concerned veterinary medicinal products remains positive subject to the recommended changes in the product information (see Annex III).
Slovenian: Splošno razmerje med tveganji in koristmi za zdravila za uporabo v veterinarski medicini iz te napotitve je bilo ocenjeno kot pozitivno, pod pogojem, da se upoštevajo priporočene spremembe informacij o zdravilu (glejte Prilogo III).
English: Study 2 investigated injection sites only, and the data from this study cannot be compared with, or combined with, the data from Study 1 due to differences in the conduct of the studies.
Slovenian: V študiji 2 so proučevali samo mesta injiciranja, zato podatkov iz te študije zaradi razlik v izvedbi študij ni mogoče primerjati ali združiti s podatki iz študije 1.
English: There were no residues depletion data provided for the last two products mentioned.
Slovenian: Za zadnji dve omenjeni zdravili podatki o izločanju ostankov niso bili predloženi.
English: As a result, a withdrawal period of 107 days was determined, using the ‘alternative' method, in line with CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)1.
Slovenian: Posledično je bila karenca 107 dni določena z uporabo alternativne metode, v skladu s sporočilom odbora CVMP glede priporočil o pristopu k usklajevanju karenc (EMEA/CVMP/036/95)1.
English: The concentration of closantel residues in the core injection site samples were below the MRL at 29 days after administration.
Slovenian: Koncentracije ostankov klozantela na mestu injiciranja so bile nižje od MRL 29 dni po dajanju.
English: 1 CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95) - link less sensitive, at 500 µg/kg.
Slovenian: 1 CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95) - link
English: Residues at the injection site were below the MRL for muscle at 61 days post administration.
Slovenian: Koncentracije ostankov na mestu injiciranja so bile v mišičju nižje od MRL 61 dni po dajanju.
English: Based on the results of a preliminary non-GLP study, only the injection site tissues were collected for analysis.
Slovenian: Na podlagi rezultatov preliminarne študije, ki ni bila skladna z dobro laboratorijsko prakso, so tkivo za analizo odvzeli le na mestih injiciranja.
English: It was considered that the presence of glycerol formal in one product would have less of an effect than propylene glycol on the overall viscosity of the product, when compared to that of water.
Slovenian: Ocenjeno je bilo, da bo prisotnost glicerol formala v posameznem zdravilu imela manjši vpliv na skupno viskoznost kot vsebnost propilenglikola v primerjavi z vodo.
English: • Although there is some uncertainty as to how the differences in formulation would affect the rate of depletion from the injection sites, the injection volumes used in Study 1 were considered to be reasonable worst case due to the weights of the animals used and the mg/kg, rather than mg/animal, dosing regimen, when compared to the recommended weights of animals in VICH GL 482.
Slovenian: • Čeprav ni popolnoma jasno, kako razlike v formulaciji vplivajo na hitrost izločanja z mest injiciranja, so se injicirani volumni, uporabljeni v študiji 1, zaradi mase uporabljenih živali in sheme odmerjanja v mg/kg namesto v mg/žival šteli za razumen najslabši možni primer glede na maso živali, priporočeno v VICH GL 482.
English: the CVMP has recommended variations of the marketing authorisations for veterinary medicinal products containing 50 mg closantel per ml (as a single active substance) presented as solutions for injection for subcutaneous use in sheep (see Annex I) in order to amend the summaries of product characteristics, labelling and package leaflets in line with recommended changes in the product information as set out in Annex III.
Slovenian: je odbor CVMP priporočil spremembo dovoljenj za promet z zdravili za uporabo v veterinarski medicini, ki vsebujejo 50 mg klozantela na ml (kot edino učinkovino), v obliki raztopine za injiciranje za subkutano uporabo pri ovcah (glejte Prilogo I), in sicer je treba popraviti povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo v skladu s priporočenimi spremembami informacij o zdravilu, opredeljenimi v Prilogi III.
English: It has been shown that, in general, the higher the viscosity of the product, the slower the rate of absorption from the injection site.
Slovenian: Dokazali so, da se viskoznost zdravila na splošno povečuje z zmanjševanjem hitrosti absorpcije z mesta injiciranja.
English: • Although there is some uncertainty as to how the differences in formulation would affect the rate of depletion from the injection sites, the injection volumes used in Study 1 were considered to be reasonable worst case, due to the weights of the animals used, and the mg/kg dosing regimen, when compared to the recommended weights of animals in VICH GL 48.
Slovenian: • Čeprav ni popolnoma jasno, kako razlike v formulaciji vplivajo na hitrost izločanja z mest injiciranja, so se injicirani volumni, uporabljeni v študiji 1, zaradi mase uporabljenih živali in sheme odmerjanja v mg/kg šteli za razumen najslabši možni primer glede na maso živali, priporočeno v VICH GL 48.
English: The different quantities included may lead to the products having different viscosities, resulting in different rates of absorption of closantel from the injection site; however, this parameter is not considered to affect the elimination rate from the edible tissues, other than at the injection site itself.
Slovenian: Razlike v količinah so lahko razlog za različne viskoznosti, kar povzroča različno hitrost absorpcije klozantela z mesta injiciranja; vendar pa ta parameter naj ne bi vplival na hitrost izločanja iz tkiv, namenjenih prehrani, razen s samega mesta injiciranja.
English: Another (nationally-authorised) version of Flukiver Solution for Injection has been authorised in France since 1981; the marketing authorisation for this product was varied in 2016 and the withdrawal periods for sheep (meat and offal) were increased from 77 days to 107 days as a result of data provided during the variation procedure.
Slovenian: Leta 2016 je bilo dovoljenje za promet s tem zdravilom spremenjeno in so se karence za ovce (meso in organe) zaradi podatkov, predloženih v postopku za spremembo dovoljenja, podaljšale s 77 dni na 107 dni.
English: Overall summary of the scientific evaluation of veterinary medicinal products containing 50 mg closantel per ml (as a single active substance) presented as solutions for injection for subcutaneous use in sheep (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravil za uporabo v veterinarski medicini, ki vsebujejo 50 mg klozantela na ml (kot edino učinkovino) in so v obliki raztopine za injiciranje za subkutano uporabo pri ovcah (glejte poglavje I)
English: Data were provided, based on the pharmacokinetics of closantel, that demonstrated that the formulation differences, and thereby the potential differences in the rates of absorption from the injection site, would not affect the overall elimination from the edible tissues, other than from the injection site itself.
Slovenian: Na podlagi farmakokinetike klozantela so bili predloženi podatki, ki so pokazali, da razlike v formulacijah in s tem morebitne razlike v hitrosti absorpcije z mesta injiciranja ne vplivajo na celokupno izločanje iz tkiv, namenjenih prehrani, razen s samega mesta injiciranja.
English: The CVMP was requested to review all available residue depletion data for the veterinary medicinal products containing 50 mg closantel per ml (as a single active substance), presented as a solution for injection for subcutaneous use in sheep and recommend withdrawal periods for meat and offal derived from treated sheep.
Slovenian: Odbor CVMP je bil zaprošen, naj pregleda vse razpoložljive podatke o izločanju ostankov zdravil za uporabo v veterinarski medicini, ki vsebujejo 50 mg klozantela na ml (kot posamezno učinkovino), v obliki raztopine za injiciranje za subkutano uporabo pri ovcah in priporoči obdobja karence za meso in organe, pridobljene iz zdravljenih ovac.
English: • The tissue-specific withdrawal period determined from Study 1 for liver was 28 days longer than that for injection sites, which leaves a suitably long time for any additional injection site residues to deplete before the 107-day withdrawal period is complete.
Slovenian: • Tkivno specifična karenca, določena za jetra v študiji 1, je bila za 28 dni daljša od karence za mesta injiciranja, kar pušča primerno dolg čas, da se pred koncem 107-dnevne karence izločijo vsi morebitni preostali ostanki zdravila.
English: It has been noted that there are different approved withdrawal periods for sheep (meat and offal) for veterinary medicinal products containing 50 mg closantel per ml (as a single active substance) presented as solution for injection for subcutaneous use in sheep across the EU, i.e., between 28 days and 107 days.
Slovenian: Ugotovljeno je bilo, da so obdobja karence za ovce (meso in organe) za zdravila, ki vsebujejo 50 mg klozantela na ml (kot edino učinkovino), v obliki raztopine za injiciranje za subkutano uporabo pri ovcah med državami članicami različna, tj. od 28 do 107 dni.
English: The product was administered via subcutaneous injection to sheep, at the single recommended dose of 5 mg closantel per kg body weight.
Slovenian: To zdravilo so dajali ovcam s subkutano injekcijo v enkratnem priporočenem odmerku 5 mg klozantela na kg telesne mase.
English: • The tissue-specific withdrawal period determined from Study 1 for liver was 28 days longer than for injection sites, leaving a long time for any additional injection site residues to deplete before the 107-day withdrawal period is complete.
Slovenian: • Tkivno specifična karenca, določena za jetra v študiji 1, je bila za 28 dni daljša od karence za mesta injiciranja, kar pušča dovolj časa, da se pred iztekom 107-dnevne karence izločijo vsi morebitni preostali ostanki zdravila.
English: Not authorised for use in ewes producing milk for human consumption including during the dry period.
Slovenian: Ni dovoljena uporaba pri ovcah mlekaricah, ki dajejo mleko, namenjeno za prehrano ljudi.
English: Santiola 50 mg/ml Solution for Injection for Cattle and Sheep sheep sheep: subcutaneous
Slovenian: Santiola 50 mg/ml Solution for Injection for Cattle and Sheep ovce ovce: subkutano
English: A GLP-compliant residue depletion study in sheep was submitted, conducted with the veterinary medicinal product ‘Flukiver 5%', a product containing 50 mg closantel per ml.
Slovenian: Predložena je bila z dobro laboratorijsko prakso skladna študija o izločanju ostankov pri ovcah, izvedena z zdravilom Flukiver 5 % za uporabo v veterinarski medicini, ki vsebuje 50 mg klozantela na ml.
English: The available data demonstrate that the liver is the withdrawal period determining tissue and that the rate of elimination from edible tissues would not be influenced by the rate of absorption from the injection site and thereby impacted by product formulation.
Slovenian: Razpoložljivi podatki kažejo, da so jetra tkivo, ki določa karenco, in da hitrost absorpcije z mesta injiciranja in s tem formulacija zdravila ne vpliva na hitrost izločanja iz tkiv, namenjenih prehrani.
English: A GLP-compliant residue depletion study in sheep was submitted, conducted with the veterinary medicinal product ‘Endoex Solucion Injectable', a product containing 50 mg closantel per ml.
Slovenian: Predložena je bila z dobro laboratorijsko prakso skladna študija o izločanju ostankov pri ovcah, izvedena z zdravilom Endoex Solucion Injectable za uporabo v veterinarski medicini, ki vsebuje 50 mg klozantela na ml. Ovcam so zdravilo dajali s subkutano injekcijo v enkratnem priporočenem odmerku 5 mg klozantela na kg telesne mase.
English: It was also shown that, in general, the higher the volume of injection, the slower the rate of absorption from the injection site.
Slovenian: Dokazali so tudi, da se hitrost absorpcije z mesta injiciranja zmanjšuje s povečevanjem injiciranega volumna.
English: EU/1/00/140/001 Visudyne
Slovenian: EU/1/00/140/001
English: powder: 15 mg 1 vial
Slovenian: 15 mg prašek za raztopino za infundiranje intravenska uporaba steklena viala Prašek: 15 mg 1 x 10 ml viala
English: Pack size
Slovenian: Visudyne
English: This summary was last updated in 09-2007
Slovenian: Ta povzetek je bil nazadnje posodobljen 09-2007.
English: The marketing authorisation was renewed on 11-2006.
Slovenian: Dovoljenje za promet z zdravilom je bilo podaljšano dne 11-2006.
English: Other information about Protopy:
Slovenian: Druge informacije o zdravilu Protopy:
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Protopy to Astellas Pharma GmbH on 28 February 2002.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Protopy, veljavno po vsej Evropski uniji, odobrila družbi Astellas Pharma GmbH dne 28. februarja 2002.
English: Protopy should not be used in children under 2 years of age.
Slovenian: Zdravila Protopy se ne sme uporabljati za otroke mlajše od 2 let.
English: Treatment should be started as twice a day for up to three weeks.
Slovenian: Zdravljenje je treba začeti z uporabo dvakrat dnevno do tri tedne.
English: Tacrolimus has been used since the mid-1990's to help prevent rejection in transplant patients (when the immune system attacks the transplanted organ).
Slovenian: Takrolimus se od sredine 1990-ih uporablja za preprečevanje zavrnitve pri bolnikih po presaditvi (ko imunski sistem napade presajeni organ).
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PROTOPY EPAR summary for the public
Slovenian: EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) PROTOPY Povzetek EPAR za javnost
English: The safety and effectiveness of Protopy has been studied in more than 13,500 patients treated with tacrolimus ointment in clinical trials.
Slovenian: Varnost in učinkovitost zdravila Protopy so preučili pri več kot 13.500 bolnikih, ki so bili v kliničnih preskušanjih zdravljeni z mazilom, ki je vsebovalo takrolimus.
English: In the longer study, Protopy could be used repeatedly without losing its effectiveness.
Slovenian: V daljši raziskavi so lahko zdravilo Protopy uporabili v ponovitvah brez zmanjšanja učinkovitosti.
English: Generally, improvement is seen within one week of starting treatment, and if there is no improvement after 2 weeks, the doctor needs to look at more treatment options.
Slovenian: Če po 2 tednih zdravljenja ni znakov izboljšanja, mora zdravnik pretehtati druge možnosti zdravljenja.
English: The exact way that Protopy works in atopic dermatitis is not yet fully understood.
Slovenian: Natančen mehanizem delovanja zdravila Protopy pri atopičnem dermatitisu še ni popolnoma znan.
English: Protopy is a white to slightly yellowish ointment that contains either 0.1% or 0.03% of the active ingredient tacrolimus.
Slovenian: Zdravilo Protopy je belo do rahlo rumenkasto mazilo, ki vsebuje bodisi 0,1 % ali 0,03 % zdravilne učinkovine takrolimus.
English: What benefit has Protopy shown during the studies?
Slovenian: Kakšne koristi je zdravilo Protopy izkazalo med raziskavami?
English: What is the risk associated with Protopy?
Slovenian: Kakšna tveganja so povezana z zdravilom Protopy?
English: In adults, treatment should be started with Protopy 0.1% twice a day and treatment should be continued until the skin is clear.
Slovenian: Pri odraslih je treba zdravljenje začeti z zdravilom Protopy 0,1% dvakrat dnevno in ga nadaljevati, dokler spremembe ne izginejo.
English: The main measure of effectiveness was the improvement in the eczema seen at the end of the study (3 or 12 weeks) using a scoring system (the modified Eczema Area and Severity Index) that looks at all the symptoms of atopic dermatitis.
Slovenian: Glavno merilo učinkovitosti je bilo izboljšanje ekcema na koncu raziskave (3 ali 12 tednov) na podlagi sistema točkovanja, imenovanega modificirani indeks površine in resnosti ekcema (Modified Eczema Area and Severity Index), ki zajema vse simptome atopičnega dermatitisa.
English: Protopy should be prescribed by a doctor with experience in the diagnosis and treatment of atopic dermatitis.
Slovenian: Zdravilo Protopy lahko predpišejo le zdravniki, ki imajo izkušnje s postavljanjem diagnoze in zdravljenjem atopičnega dermatitisa.
English: Tacrolimus, the active substance in Protopy, is an immunomodulator, this means that it works on the immune system (the body's natural defences).
Slovenian: Takrolimus, zdravilna učinkovina zdravila Protopy, je imunomodulator, kar pomeni, da deluje na imunski sistem (naravne obrambne mehanizme telesa).
English: Protopy should not be used continuously.
Slovenian: Zdravilo Protopy ni za stalno uporabo.
English: The lower strength of Protopy (0.03%) may also be used for this condition in children (2 years of age and above) who do not respond well to, or do not tolerate usual treatments.
Slovenian: Oblika zdravila Protopy z manjšo jakostjo (0,03 %) se lahko uporablja tudi za zdravljenje tega stanja pri otrocih (starih 2 leti ali več), ki se neustrezno odzivajo na običajne terapije ali pa jih ne prenašajo.
English: Protopy should not be used in people who may be hypersensitive (allergic) to tacrolimus or to any of the other ingredients.
Slovenian: Zdravila Protopy ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) takrolimus ali katerokoli drugo sestavino zdravila.
English: In atopic dermatitis, an over-reaction of the skin's immune system causes skin inflammation (itchiness, redness, dryness).
Slovenian: atopičnem dermatitisu čezmerna reakcija imunskega sistema v koži povzroči vnetje kože (srbečico, pordelost, izsušenost).
English: If possible, patients should use less frequent applications, or the lower strength as their condition improves.
Slovenian: Ko se stanje izboljša, naj bolniki uporabljajo zdravilo redkeje ali v obliki z manjšo jakostjo, če je možno.
English: The most common side effects (seen in more than 1 patient in 10) are burning sensation and itching at the application site.
Slovenian: Najpogostejša neželena učinka (opažena pri več kot 1 bolniku od 10) sta bila pekoč občutek in srbečica ne mestu uporabe.
English: Another study has also looked at the use of Protopy for up to 4 years in about 800 patients.
Slovenian: V drugi raziskavi so pri 800 bolnikih preverili uporabo zdravila Protopy, ki je trajala 4 leta.
English: Why has Protopy been approved?
Slovenian: Zakaj je bilo zdravilo Protopy odobreno?
English: In children, only the lowest strength Protopy 0.03% should be used.
Slovenian: Pri otrocih je treba uporabiti obliko zdravila Protopy z manjšo jakostjo (0,03 %).
English: Tacrolimus calms down the immune system, and this helps relieve the skin inflammation and the itch.
Slovenian: Takrolimus umiri imunski sistem, kar olajša vnetje kože in srbečico.
English: They recommended that Protopy be given marketing authorisation.
Slovenian: Odbor je za zdravilo Protopy priporočil odobritev dovoljenja za promet z zdravilom.
English: Protopy is used for the treatment of moderate to severe atopic dermatitis (eczema, an itchy red rash of the skin- atopic means that is linked to an allergy) in adults who do not respond well or do not tolerate usual treatments.
Slovenian: Zdravilo Protopy se uporablja za zdravljenje zmernega do hudega atopičnega dermatitisa (ekcema, srbečega kožnega izpuščaja s pordelostjo; atopičen pomeni, da je povezan z alergijo) pri odraslih, ki se na običajne terapije ne odzovejo ustrezno ali jih ne prenesejo.
English: Protopy was significantly more effective than either of the 2 hydrocortisone preparations at producing improvements in the modified Eczema Area and Severity Index, although it also produced more burning than hydrocortisone.
Slovenian: Zdravilo Protopy je bilo statistično značilno učinkovitejše od obeh hidrokortizonskih pripravkov pri spodbujanju napredka po indeksu površine in resnosti ekcema, čeprav je v več primerih povzročil pekoč občutek kot hidrokortizon.
English: Doctors must be aware that a very small number of patients using the medicine have developed cancer (skin cancer, lymphoma).
Slovenian: Zelo majhno število bolnikov je imelo raka (kožnega raka, limfom) v času uporabe zdravila.
English: Each affected area is treated with Protopy until the skin is clear and then treatment should be stopped.
Slovenian: Vsak prizadeti predel kože je treba z zdravilom Protopy zdraviti, dokler spremembe ne izginejo.