natgillin/translations-raw huggingface dataset:
Individuals 9 to and including 13 years of age Gardasil can be administered according to a 2-dose schedule (0.5 ml at 0, 6 months) (see section 5.1). 
Cepivo Gardasil se lahko aplicira v skladu z 2-odmerno shemo cepljenja (0,5 ml v 0. in 6. mesecu) (glejte poglavje 5.1).
Men vaccinated with Gardasil at 16-26 years of age in Protocol 020 base study were followed up in an extension study. 
Moške, cepljene s cepivom Gardasil v starosti od 16 do 26 let v izhodiščni študiji po protokolu 020, so spremljali v podaljšanju študije.
In the long-term extension study of Protocol 018, 369 girls 9-15 years old during vaccination with Gardasil in the base study were followed. 
V dolgotrajnem podaljšanju študije po protokolu 018 so spremljali 369 deklic, ob cepljenju s cepivom Gardasil v izhodiščni študiji starih od 9 do 15 let.
If you forget one dose of Gardasil: 
Če enega odmerka cepiva Gardasil niste prejeli
Gardasil, suspension for injection - single dose vial, pack of 1, 10, 20 
Gardasil suspenzija za injiciranje - enoodmerna viala, pakiranje po 1, 10, 20
In the long-term extension study of Protocol 020, 917 men 16-26 years old during vaccination with Gardasil in the base study were followed. 
V dolgotrajnem podaljšanju študije po protokolu 020 so spremljali 917 moških, ob cepljenju s cepivom Gardasil v izhodiščni študiji starih od 16 do 26 let.
In a subset of 598 men (GARDASIL = 299; placebo = 299) in Protocol 020 who self-identified as having sex with men (MSM) efficacy against anal intraepithelial neoplasia (AIN grades 1/2/3) and anal cancer, and intra-anal persistent infection was evaluated. 
Učinkovitost proti analnim intraepitelijskim neoplazijam (AIN stopnje 1/2/3) in analnemu raku ter persistentni intraanalni okužbi so v Protokolu 020 ocenili v podskupini 598 moških (GARDASIL= 299, placebo = 299), ki so sami navedli, da imajo spolne odnose z moškimi (populacija MSM).
The Full Analysis Set population (also known as the ITT population) included women regardless of baseline HPV status at Day 1, who received at least one vaccination and in whom case counting started at Day 1. 
Populacija za analizo vseh podatkov (znana tudi kot ITT populacija) je vključevala ženske ne glede na status HPV 1. dan, ki so prejele vsaj 1 odmerek cepiva, štetje primerov pa se je začelo 1. dan. Glede na prevalenco okužb s HPV in bolezni ob vključitvi ta populacija približno ustreza splošni populaciji žensk.
HPV 16/18related CIN 2/3 or AIS HPV 16/18related CIN 3 
CIN 2/3 ali AIS, povezana s HPV 16/18 CIN 3,
Gardasil should be administered according to a 3-dose schedule: - First injection: at chosen date - Second injection: 2 months after first injection - Third injection: 6 months after first injection The second dose should be administered at least one month after the first dose and the third dose should be administered at least 3 months after the second dose. 
• Tretja injekcija: 6 mesecev po prvi injekciji Drugi odmerek je treba dati vsaj en mesec po prvem odmerku, tretji odmerek pa vsaj 3 mesece po drugem odmerku.
Women vaccinated with Gardasil at 16-23 years of age in Protocol 015 base were followed up in an extension study. 
Ženske, cepljene s cepivom Gardasil v starosti od 16 do 23 let v izhodiščni študiji po protokolu 015, so spremljali v podaljšanju študije.
How to store Gardasil 
Shranjevanje cepiva Gardasil
In the long-term extension study of Protocol 018, 326 boys 9-15 years old during vaccination with Gardasil in the base study were followed. 
V dolgotrajnem podaljšanju študije po protokolu 018 so spremljali 326 dečkov, ob cepljenju s cepivom Gardasil v izhodiščni študiji starih od 9 do 15 let.
Gardasil, suspension for injection in a pre-filled syringe : 
Gardasil suspenzija za injiciranje v napolnjeni injekcijski brizgi:
In the PPE population no cases of HPV diseases (HPV types 6/11/16/18 related high grade CIN) were observed up to approximately 14 years (median followup of 11.9 years). 
V PPE populaciji v obdobju do približno 14 let (mediani čas spremljanja 11,9 leta) niso odkrili primerov bolezni zaradi HPV (s HPV tipi 6/11/16/18 povezana CIN visoke stopnje).
Gardasil suspension for injection in a pre-filled syringe 
Gardasil suspenzija za injiciranje Gardasil suspenzija za injiciranje v napolnjeni injekcijski brizgi
Ten years after vaccination, 79%, 80%, 95% and 40% were anti-HPV 6, antiHPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the cLIA, respectively, and 92%, 92%, 100% 
Deset let po cepljenju je bilo 79 %, 80 %, 95 % oziroma 40 % oseb seropozitivnih po metodi cLIA za anti-HPV 6, anti-HPV 11, anti-HPV 16 oziroma anti-HPV 18, ter 92 %, 92 %, 100 % oziroma 92 % oseb seropozitivnih po metodi IgG LIA za anti-HPV 6, anti-HPV 11, anti-HPV 16 oziroma anti-HPV 18.
20 single dose vials, 0.5 ml each. 
suspenzija za injiciranje 1 enoodmerna viala, 0,5 ml 10 enoodmernih vial, vsaka 0,5 ml 20 enoodmernih vial, vsaka 0,5 ml
In the clinical study in women 24 to 45 years, 98.4%, 98.1%, 98.8%, and 97.4% of individuals who received Gardasil became anti-HPV 6, anti-HPV 11, antiHPV 16, and anti-HPV 18 seropositive, respectively, by 1 month Postdose 3. 
V kliničnih študijah pri ženskah, starih od 24 do 45 let, je bilo 1 mesec po prejemu tretjega odmerka cepiva Gardasil anti-HPV 6 seropozitivnih 98,4 % oseb, anti-HPV 11 seropozitivnih 98,1 % oseb, anti-HPV 16 seropozitivnih 98,8 % oseb in anti-HPV 18 seropozitivnih 97,4 % oseb.
• the efficacy of Gardasil against HPV 6-, 11-, 16-, 18-related CIN (1, 2, 3) or AIS was 96.0% 
• učinkovitost cepiva Gardasil proti s HPV 6, 11, 16 in 18 povezanim CIN (1, 2, 3) ali AIS 96,0 % (95-odstotni IZ: 92,3; 98,2);
In the clinical studies in women 16 to 26 years of age, 99.8%, 99.8%, 99.8%, and 99.5% of individuals who received Gardasil became anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18-seropositive, respectively, by 1 month Postdose 3. 
V kliničnih študijah pri ženskah, starih 16 do 26 let, je bilo 1 mesec po prejemu tretjega odmerka cepiva Gardasil anti-HPV 6 seropozitivnih 99,8 % oseb, anti-HPV 11 seropozitivnih 99,8 % oseb, anti-HPV 16 seropozitivnih 99,8 % oseb in anti-HPV 18 seropozitivnih 99,5 % oseb.
The efficacy of Gardasil against the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection, genital warts, vulvar and vaginal lesions, CIN of any grade, AIS, and cervical cancers was 88.7% (95% CI: 78.1, 94.8). 
Učinkovitost cepiva Gardasil proti kombinirani pojavnosti s HPV 6, HPV 11, HPV 16 ali HPV 18 povezane persistentne okužbe, bradavic na spolovilih, sprememb na vulvi in nožnici, CIN katere koli stopnje, AIS in raka na materničnem vratu je bila 88,7 % (95-odstotni IZ: 78,1; 94,8).
Sodium chloride L-histidine Polysorbate 80 
6.1 Seznam pomožnih snovi natrijev klorid L-histidin polisorbat 80 natrijev borat voda za injekcije
In these studies, individuals who were seronegative for anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18 in the cLIA were still protected against clinical disease after a follow-up of 14 years for 16-23 year-old women, 10 years for 24-45 year-old women, and 10 years for 16-26 year-old men. 
V teh študijah so bile po 14-letnem spremljanju žensk, starih od 16 do 23 let, 10-letnem spremljanju žensk, starih od 24 do 45 let in 10-letnem spremljanju moških, starih od 16 do 26 let, osebe, ki so bile po metodi cLIA seronegativne za anti-HPV 6, anti-HPV 11, anti-HPV 16 in anti-HPV 18, še vedno zaščitene pred klinično boleznijo.
In the PPE population, no cases of HPV diseases (HPV types 6/11/16/18 related External Genital Lesions) were observed through 10.6 years (median followup of 9.9 years). 
V PPE populaciji v obdobju 10,6 leta (mediani čas spremljanja 9,9 leta) niso odkrili primerov bolezni zaradi HPV (s HPV tipi 6/11/16/18 povezane lezije na zunanjih spolovilih).
Gardasil suspension for injection in a pre-filled syringe Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed) 
Gardasil suspenzija za injiciranje v napolnjeni injekcijski brizgi adsorbirano rekombinantno cepivo proti humanim papilomavirusom [tipom 6, 11, 16 in 18]
The efficacy of Gardasil against the combined incidence of HPV 16- or 18-related persistent infection, genital warts, vulvar and vaginal lesions, CIN of any grade, AIS, and cervical cancers was 41.6% (95% CI: 24.3, 55.2). 
Učinkovitost cepiva Gardasil proti kombinirani pojavnosti s HPV 16 ali HPV 18 povezane persistentne okužbe, bradavic na spolovilih, sprememb na vulvi in nožnici, CIN katere koli stopnje, AIS in raka na materničnem vratu je bila 41,6 % (95-odstotni IZ: 24,3; 55,2).
Gardasil, suspension for injection - pre-filled syringe with 1 needle, pack of 1, 10, 20 
Gardasil suspenzija za injiciranje - napolnjena injekcijska brizga z 1 iglo, pakiranje po 1, 10, 20
In the clinical study in men 16 to 26 years, 98.9%, 99.2%, 98.8%, and 97.4% of individuals who received Gardasil became anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18 seropositive, respectively, by 1 month Postdose 3. 
V klinični študiji pri moških, starih od 16 do 26 let, je med tistimi, ki so prejeli cepivo Gardasil, postalo v 1 mesecu po 3. odmerku anti-HPV 6 seropozitivnih 98,9 %, anti-HPV 11 seropozitivnih 99,2 %, anti-HPV 16 seropozitivnih 98,8 % in anti-HPV 18 seropozitivnih 97,4 %.
The efficacy of Gardasil against the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection, genital warts, vulvar and vaginal lesions, CIN of any grade, AIS, and cervical cancers was 47.2% (95% CI: 33.5, 58.2). 
Učinkovitost cepiva Gardasil proti kombinirani pojavnosti s HPV 6, HPV 11, HPV 16 ali HPV 18 povezane persistentne okužbe, bradavic na spolovilih, sprememb na vulvi in nožnici, CIN katere koli stopnje, AIS in raka na materničnem vratu je bila 47,2 % (95-odstotni IZ: 33,5; 58,2).
The efficacy of Gardasil against the combined incidence of HPV 16- or 18-related persistent infection, genital warts, vulvar and vaginal lesions, CIN of any grade, AIS, and cervical cancers was 84.7% (95% CI: 67.5, 93.7). 
Učinkovitost cepiva Gardasil proti kombinirani pojavnosti s HPV 16 ali HPV 18 povezane persistentne okužbe, bradavic na spolovilih, sprememb na vulvi in nožnici, CIN katere koli stopnje, AIS in raka na materničnem vratu je bila 84,7 % (95-odstotni IZ: 67,5; 93,7)
The following side effects can be seen after the use of Gardasil: 
Po uporabi cepiva Gardasil so poročali o naslednjih neželenih učinkih:
Gardasil, suspension for injection - pre-filled syringe without needle, pack of 1, 10, 20 
Gardasil suspenzija za injiciranje - napolnjena injekcijska brizga brez igle, pakiranje po 1, 10,
Frequency Adverse Events 
Opazovani dogodek
Gardasil, suspension for injection - pre-filled syringe with 2 needles, pack of 1, 10, 20 
Gardasil suspenzija za injiciranje - napolnjena injekcijska brizga z 2 iglama, pakiranje po 1, 10,
Gardasil suspension for injection Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed) 
Gardasil suspenzija za injiciranje adsorbirano rekombinantno cepivo proti humanim papilomavirusom [tipom 6, 11, 16 in 18]
types - genital warts (condyloma acuminata) causally related to specific HPV types. 
raka materničnega vratu in raka anusa, ki so vzročno povezani z določenimi onkogenimi tipi humanih papilomavirusov (HPV) - bradavic na spolovilih (koničasti kondilomi), ki so vzročno povezane s specifičnimi tipi HPV.
The efficacy of Gardasil in 16- through 26 year-old women was assessed in 4 placebo-controlled, double-blind, randomised Phase II and III clinical studies including a total of 20,541 women, who were enrolled and vaccinated without pre-screening for the presence of HPV infection. 
Učinkovitost cepiva Gardasil pri ženskah, starih 16 do 26 let, je bila ovrednotena v 4-ih s placebom nadzorovanih, dvojno slepih, randomiziranih kliničnih študijah II.
In the PPE population, no cases of HPV diseases (HPV types 6/11/16/18 related CIN any grade and Genital Warts) were observed through 10.7 years (median follow-up of 10.0 years). 
V PPE populaciji v obdobju 10,7 leta (mediani čas spremljanja 10,0 leta) niso odkrili primerov bolezni zaradi HPV (s HPV tipi 6/11/16/18 povezana CIN katere koli stopnje in bradavice na spolovilih).
At end of study and in the combined protocols, • the efficacy of Gardasil against HPV 6-, 11-, 16-, 18-related CIN 1 was 95.9 % (95% CI: 91.4, 
• učinkovitost cepiva Gardasil proti s HPV 6, 11, 16 in 18 povezanim CIN 1 95,9 % (95-odstotni IZ: 91,4; 98,4);
Gardasil, suspension for injection in a pre-filled syringe Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed) 
Gardasil suspenzija za injiciranje Gardasil suspenzija za injiciranje v napolnjeni injekcijski brizgi adsorbirano rekombinantno cepivo proti humanim papilomavirusom [tipom 6, 11, 16 in 18]
The efficacy of Gardasil in 16- through 26 year-old men was assessed in 1 placebo-controlled, doubleblind, randomised Phase III clinical study (Protocol 020) including a total of 4,055 men who were enrolled and vaccinated without pre-screening for the presence of HPV infection. 
Učinkovitost cepiva Gardasil pri moških v starosti od 16 do 26 let so ocenili v 1 s placebom kontrolirani, dvojno slepi randomizirani klinični študiji faze III (Protokol 020).
Suspension for injection in a pre-filled syringe. 
Gardasil suspenzija za injiciranje v napolnjeni injekcijski brizgi i.m.
• the efficacy of Gardasil against HPV 6-, 11-, 16-, 18-related genital warts was 99.0% (95% CI: 
• učinkovitost cepiva Gardasil proti s HPV 6, 11, 16 in 18 povezanimi bradavicami 99,0 % (95-odstotni IZ: 96,2; 99,9).
1 dose (0.5 ml) contains: HPV Type 6 L1 protein 20 µg HPV Type 11 L1 protein 40 µg HPV Type 16 L1 protein 40 µg HPV Type 18 L1 protein 20 µg adsorbed on amorphous aluminium hydroxyphosphate sulphate (0.225 mg Al). 
suspenzija za injiciranje v napolnjeni injekcijski brizgi 1 odmerek, 0,5 ml napolnjena injekcijska brizga z 2 iglama 10 enkratnih odmerkov, 0,5 ml napolnjene injekcijske brizge, vsaka z 2 iglama 20 enkratnih odmerkov, 0,5 ml napolnjene injekcijske brizge, vsaka z 2 iglama
EU/1/06/357/007 - pack of 1 EU/1/06/357/008 - pack of 10 EU/1/06/357/021 - pack of 20 
EU/1/06/357/007 - pakiranje po 1 EU/1/06/357/008 - pakiranje po 10 EU/1/06/357/021 - pakiranje po 20
EU/1/06/357/003 - pack of 1 EU/1/06/357/004 - pack of 10 EU/1/06/357/019 - pack of 20 
EU/1/06/357/003 - pakiranje po 1 EU/1/06/357/004 - pakiranje po 10 EU/1/06/357/019 - pakiranje po 20
EU/1/06/357/005 - pack of 1 EU/1/06/357/006 - pack of 10 EU/1/06/357/020 - pack of 20 
EU/1/06/357/005 - pakiranje po 1 EU/1/06/357/006 - pakiranje po 10 EU/1/06/357/020 - pakiranje po 20
EU/1/06/357/001 - pack of 1 EU/1/06/357/002- pack of 10 EU/1/06/357/018- pack of 20 
EU/1/06/357/001 - pakiranje po 1 EU/1/06/357/002 - pakiranje po 10 EU/1/06/357/018 - pakiranje po 20
cases cases 
primeri primeri
Gardasil induced specific antibody responses against HPV types 6, 11, 16, and 18 in pregnant rats, following one or multiple intramuscular injections. 
Pri brejih podganah je cepivo Gardasil po enkratnem ali večkratnem intramuskularnem injiciranju sprožilo odziv v obliki pojava specifičnih protiteles proti tipom 6, 11, 16 in 18 HPV.
Gardasil suspension for injection IM use. 
Gardasil suspenzija za injiciranje i.m.
10 single doses, 0.5 ml pre-filled syringes with 1 needle each. 
suspenzija za injiciranje v napolnjeni injekcijski brizgi 1 odmerek, 0,5 ml napolnjena injekcijska brizga z 1 iglo 10 enkratnih odmerkov, 0,5 ml napolnjene injekcijske brizge, vsaka z 1 iglo 20 enkratnih odmerkov, 0,5 ml napolnjene injekcijske brizge, vsaka z 1 iglo
Qualitative and quantitative composition 
Kakovostna in količinska sestava
Meat and offal: 107 days. 
Meso in organi: 107 dni.
Finally, consideration has been given to the analytical methods that were used. 
Končno sta bili obravnavani tudi uporabljeni analizni metodi.
Information was received regarding the composition of the affected products (n = 5). 
Prejete so bile informacije o sestavi zadevnih zdravil (n = 5).
The reasoning being that: 
Ob upoštevanju naslednjega:
In addition, different breeds of sheep were used in each of the studies provided. 
Poleg tega so v vsaki od predloženih študij uporabili drugo pasmo ovac.
Quality, target animal safety, user safety, environmental risk and parasitic resistance for the concerned veterinary medicinal products have not been assessed in this referral procedure. 
Kakovost, varnost za ciljno živalsko vrsto, varnost uporabnikov, tveganje za okolje in odpornost parazitov proti zadevnim zdravilom za veterinarsko uporabo v tem napotitvenem postopku niso bili ocenjeni.
Risk management or mitigation measures 
Ukrepi za obvladovanje ali zmanjševanje tveganja
The two products used in the studies include almost the same excipients, but in different quantities. 
Obe zdravili, uporabljeni v študijah, vsebujeta skoraj enake pomožne snovi, vendar v različnih količinah.
The differences between the two residues studies have been considered. 
Obravnavana je bila razlika med obema študijama izločanja ostankov.
One of these products (‘Flukiver 5%') was used in the pivotal residues study, Study 1. 
Eno od teh zdravil (Flukiver 5 %) so uporabili v ključni študiji ostankov, študiji 1.
Residues depletion data were submitted by two of the affected marketing authorisation holders. 
Podatke o izločanju ostankov sta predložila dva zadevna imetnika dovoljenja za promet z zdravilom.
To ensure the safety of consumers of food and food products derived from animals treated with products containing closantel, the European Commission has set MRLs for closantel in the edible tissues of sheep. 
Da bi zagotovili varnost potrošnikov živil in prehrambnih izdelkov, proizvedenih iz živali, zdravljenih z zdravili, ki vsebujejo klozantel, je Evropska komisija določila MRL za klozantel v tkivih ovac, namenjenih prehrani.
In order for closantel-derived residues to deplete below the MRLs, a sufficient time between treatment and slaughter must be allowed. 
Da bi se lahko koncentracija ostankov klozantela znižala pod MRL, mora med zdravljenjem in zakolom miniti zadosten čas.
The main non-aqueous vehicle, propylene glycol, is present in both products in different quantities. 
Glavni nevodni vehikel, propilenglikol, je v obeh zdravilih prisoten v različnih količinah.
It cannot be concluded from the data available whether these breed differences had any influence on the depletion patterns seen. 
Iz razpoložljivih podatkov ni mogoče sklepati, ali so te razlike med pasmami kakorkoli vplivale na opažene vzorce izločanja.
It is slowly released from plasma and very slowly metabolised, and is therefore retained in the circulation for a long time; the plasma elimination half-life in sheep is 22.7 days. 
Iz plazme se sprošča počasi in se zelo počasi presnavlja, zato dolgo ostane v obtoku; pri ovcah znaša razpolovni čas izločanja iz plazme 22,7 dneva.
While the efficacy of the concerned products in sheep has not been specifically assessed as part of this referral, the products under assessment are considered to be effective in the treatment and prevention of infestations with named parasites. 
Čeprav učinkovitost zadevnih zdravil pri ovcah v okviru napotitve ni bila natančno ovrednotena, se šteje, da so ocenjevana zdravila učinkovita pri zdravljenju in obvladovanju infestacije z navedenimi paraziti.
The first timepoint where all residues are below the authorised MRL is at 89 days, and, with the addition of a safety span of 20% to take into account the variability of depletion between the animals used, a withdrawal period of 107 days is calculated. 
Prva časovna točka, v kateri so vsi ostanki pod dovoljeno MRL, je 89 dni in ob dodatku 20-odstotnega varnostnega razpona za upoštevanje razlik v izločanju med uporabljenimi živalmi znaša izračunana karenca 107 dni;
The reference product is Flukiver 50 mg/ml Solution for Injection, which has been authorised in various Member States since 1989. 
Referenčno zdravilo je zdravilo Flukiver 50 mg/ml raztopina za injiciranje, ki je bilo od leta 1989 odobreno v različnih državah članicah.
Both marketing authorisation holders provided reports detailing the validation of the analytical method used, and the performance characteristics were mostly described in accordance with current standards. 
Oba imetnika dovoljenja za promet z zdravilom sta predložila poročilo, v katerem sta opisala uporabljeno analizno tehniko, zmogljivostne karakteristike pa so bile večinoma opisane v skladu z veljavnimi standardi.
Most (90%) of a dose of closantel is excreted unchanged in the bile/faeces after intramuscular administration, but only 10% within 48 hours, after which the rate slows further so that 1 - 2% of the dose is eliminated each day. 
Večina (90 %) odmerka klozantela se po intramuskularnem dajanju izloči nespremenjenega z žolčem/blatom, vendar le 10 % v 48 urah, nato pa se hitrost izločanja nadalje zmanjša, tako da se vsak dan izloči od 1 do 2 % odmerka.
The last product is formulated with a large percentage of glycerol formal. 
To zdravilo je bilo formulirano z velikim deležem glicerol formala.
This mitigation measure was thoroughly evaluated and discussed by the CVMP, and determined to be unnecessary. 
Odbor CVMP je ta ublažitveni ukrep celovito ocenil in obravnaval ter sklenil, da ni potreben.
Closantel is a salicylanilide anthelmintic, a synthetic antiparasitic agent with efficacy against liver fluke, haematophagous nematodes and larval stages of some arthropods in sheep and cattle. 
Klozantel je salicilanilidni antihelmintik, sintetična protiparazitska snov, ki učinkuje proti jetrnemu metljaju, hematofagnim nematodom in larvalnim fazam nekaterih členonožcev pri govedu in ovcah.
Two of the product formulations are very similar, being solutions with similar excipients, and using a similar proportion of water and propylene glycol as the vehicle. 
Dve od formulacij sta si zelo podobni, in sicer gre za raztopini s podobnimi pomožnimi snovmi ter podobnim deležem vode in propilenglikola kot vehiklom.
This is considered to be an important parameter affecting the residues at the injection site. 
To se je štelo za pomemben parameter, ki vpliva na koncentracijo ostankov na mestu injiciranja.
The residue depletion data for the marker tissue, liver, do not allow for a statistical determination of a withdrawal period (the assumption of normal distribution of the errors was not met). 
Podatki o izločanju ostankov za ciljno tkivo, tj. jetra, ne omogočajo statistične določitve karence (predpostavka o normalni porazdelitvi napak ni bila izpolnjena).
The specified pH of the products used in studies 1 and 2 were in the same range; the effect of pH to explain any differences can thus be ruled out. 
Določeni pH zdravil, uporabljenih v študijah 1 in 2, je bil v istem razponu; z vplivom pH torej ni mogoče razložiti razlik.
All edible tissues, including injection sites, were sampled on days 19, 40, 61, 89, and 103 after treatment and analysed using an SPE-LC-MS/MS method of analysis, validated in line with current requirements. 
Vsa tkiva, namenjena prehrani, vključno z mesti injiciranja, so vzorčili 19., 40., 61., 89. in 103. dan po zdravljenju in analizirali z analizno metodo SPE-LC MS/MS, validirano v skladu z veljavnimi zahtevami.
The recommended doses are 2.5 mg or 5 mg closantel per kg body weight (bw) for cattle and sheep, depending on the parasitic species and/or parasitic life stage at the time of treatment. 
Priporočena odmerka sta 2,5 mg in 5 mg klozantela na kilogram telesne mase pri govedu in ovcah, odvisno od parazitske vrste in/ali parazitske življenjske faze v času zdravljenja.
Both studies administered a dose of 5 mg/kg body weight; however, due to differences in the weights of the animals used in the two studies, the volume of product administered was different (6.7 - 8.4 ml administered in Study 1; 3.6 - 5.8 ml administered in Study 2). 
Pri obeh študijah so uporabili odmerek 5 mg/kg telesne mase; vendar pa se je zaradi razlike v masah živali, uporabljenih pri obeh študijah, volumen danega zdravila razlikoval (6,7-8,4 ml, injiciran v študiji 1; 3,6-5,8 ml, injiciran v študiji 2).
Another product has propylene glycol as the main vehicle, and includes no water for injections. 
Eno od zdravil ima propilenglikol kot glavni vehikel in ne vsebuje vode za injiciranje.