natgillin/translations-raw huggingface dataset:
Women vaccinated with Gardasil at 16-23 years of age in Protocol 015 base were followed up in an extension study.
Žene cijepljene cjepivom Gardasil u dobi od 16 do 23 godina u temeljnom ispitivanju prema Protokolu 015 praćene su u produžetku ispitivanja.
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).
U PPE populaciji nije bio opažen nijedan slučaj HPV bolesti (vanjske genitalne lezije povezane s HPV tipovima 6/11/16/18) tijekom 10,6 godina (medijan praćenja od 9,9 godina).
Ten years after vaccination, 79%, 85%, 94%, and 36% were anti-HPV 6, antiHPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the cLIA, respectively, and 86%, 79%, 100% and 83% were anti-HPV 6, anti-HPV 11, anti-HPV 16 and anti-HPV 18 seropositive in the IgG LIA, respectively.
Deset godina nakon cijepljenja, 79% bilo je seropozitivno na tip 6 HPV-a, 85% na tip 11, 94% na tip 16 i 36% na tip 18, na temelju nalaza cLIA testa, a na temelju nalaza IgG LIA testa 86% bilo je seropozitivno na tip 6 HPV-a, 79% na tip 11, 100% na tip 16 i 83% na tip 18.
Efficacy in Men naïve to the relevant vaccine HPV types
Djelotvornost u muškaraca koji do sada nisu bili u kontaktu s relevantnim tipovima HPV-a sadržanim u cjepivu
cases cases
slučajevi slučajevi
• the efficacy of Gardasil against HPV 6-, 11-, 16-, 18-related CIN (1, 2, 3) or AIS was 96.0%
• djelotvornost cjepiva Gardasil protiv CIN-a (1, 2, 3) ili AIS-a povezanih s HPV-om tipova 6, 11, 16 i 18 iznosila je 96,0% (95% CI: 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.
U kliničkim ispitivanjima u žena u dobi od 16 do 26 godina, 99,8% postalo ih je seropozitivno na HPV 6, 99,8% na HPV 11, 99,8% na HPV 16 te 99,5% na HPV 18 mjesec dana nakon 3. doze.
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,
• djelotvornost cjepiva Gardasil protiv CIN-a 1 povezanog s HPV-om tipova 6, 11, 16 i 18 iznosila je 95,9 % (95% CI: 91,4; 98,4),
Gardasil, suspension for injection - single dose vial, pack of 1, 10, 20
Gardasil, suspenzija za injekciju - jednodozna bočica, pakiranje od 1, 10, 20
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 godina nakon cijepljenja, 79% bilo je seropozitivno na tip 6 HPV-a, 80% na tip 11; 95% na tip 16 i 40% na tip 18, na temelju nalaza cLIA testa, a na temelju nalaza IgG LIA testa 92% bilo je seropozitivno na tip 6 HPV-a, 92% na tip 11; 100% na tip 16 i 92% na tip 18.
Sodium chloride L-histidine Polysorbate 80
6.1 Popis pomoćnih tvari natrijev klorid L-histidin polisorbat 80 natrijev tetraborat voda za injekcije
Gardasil may be administered concomitantly with a combined booster vaccine containing diphtheria (d) and tetanus (T) with either pertussis [acellular, component] (ap) and/or poliomyelitis [inactivated] (IPV) (dTap, dT-IPV, dTap-IPV vaccines) with no significant interference with antibody response to any of the components of either vaccine.
Gardasil se može primijeniti istodobno s kombiniranim cjepivom docjepljivanja koje sadrži difteriju (d) i tetanus (T) zajedno s pertusisom [acelularni, komponentni] (ap) i/ili poliomijelitisom
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).
Djelotvornost cjepiva Gardasil s obzirom na kombiniranu incidenciju perzistentne infekcije, genitalnih bradavica, vulvarnih i vaginalnih lezija, CIN-a bilo kojeg stupnja, AIS-a i karcinoma vrata maternice povezanih s HPV-om 16 ili 18 iznosila je 41,6% (95% CI: 24,3; 55,2).
Gardasil, suspension for injection - pre-filled syringe without needle, pack of 1, 10, 20
Gardasil, suspenzija za injekciju- napunjena štrcaljka bez igle, pakiranje od 1, 10, 20
The efficacy of Gardasil against CIN (any grade) and CIN 2/3 or AIS caused by 10 non-vaccine HPV types (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59) structurally related to HPV 16 or HPV 18 was evaluated in the combined Phase III efficacy database (N = 17,599) after a median follow-up of 3.7 years (at end of study).
Nakon medijana trajanja praćenja od 3,7 godine (na kraju ispitivanja), analizirani su objedinjeni podaci ispitivanja faze III (N = 17 599) u kojima je ispitana djelotvornost cjepiva Gardasil protiv CINa (bez obzira na stupanj) i CIN-a 2/3 ili AIS-a uzrokovanih s 10 HPV tipova koji nisu sadržani u cjepivu (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59) strukturno povezanih s HPV-om 16 odnosno 18.
Longer term follow-up studies were conducted to determine the duration of protection.
Provedena su ispitivanja s dugotrajnim praćenjem kako bi se odredilo trajanje zaštite (vidjeti dio 5.1).
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).
Djelotvornost cjepiva Gardasil s obzirom na kombiniranu incidenciju perzistentne infekcije, genitalnih bradavica, vulvarnih i vaginalnih lezija, CIN-a bilo kojeg stupnja, AIS-a i karcinoma vrata maternice povezanih s tipovima HPV-a 6, 11, 16 ili 18 iznosila je 88,7% (95% CI: 78,1; 94,8).
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.
U kliničkom ispitivanju u muškaraca u dobi od 16 do 26 godina, 98,9% postalo je seropozitivno na HPV 6, 99,2% na HPV 11, 98,8% na HPV 16 te 97,4% na HPV 18 mjesec dana nakon 3. doze.
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).
Djelotvornost cjepiva Gardasil s obzirom na kombiniranu incidenciju perzistentne infekcije, genitalnih bradavica, vulvarnih i vaginalnih lezija, CIN-a bilo kojeg stupnja, AIS-a i karcinoma vrata maternice povezanih s tipovima HPV-a 16 ili 18 iznosila je 84,7% (95% CI: 67,5; 93,7).
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).
U PPE populaciji nije bio opažen nijedan slučaj HPV bolesti (bilo koji stupanj CIN-a povezan s HPV tipovima 6/11/16/18 i genitalne bradavice) tijekom 10,7 godina (medijana praćenja od 10,0 godina).
On the basis of this immunogenicity bridging, the efficacy of Gardasil in 9- to 15-year-old boys is inferred.
Djelotvornost cjepiva Gardasil u dječaka u dobi od 9 do 15 godina pokazana je na temelju ove ekstenzije podataka imunogenosti.
On the basis of this immunogenicity bridging, the efficacy of Gardasil in 9- to 15-year-old girls is inferred.
Djelotvornost cjepiva Gardasil u djevojčica u dobi od 9 do 15 godina pokazana je na temelju ove ekstenzije podataka imunogenosti.
1 Type 16 L1 protein
40 mikrograma humani papilomavirus 1 tip 16 L1 protein
Gardasil, suspension for injection - pre-filled syringe with 2 needles, pack of 1, 10, 20
Gardasil, suspenzija za injekciju- napunjena štrcaljka s 2 igle, pakiranje od 1, 10, 20
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).
Djelotvornost cjepiva Gardasil obzirom na kombiniranu incidenciju perzistentne infekcije, genitalnih bradavica, vulvarnih i vaginalnih lezija, CIN-a bilo kojeg stupnja, AIS-a i karcinoma vrata maternice povezanih s HPV-om 6, 11, 16 ili 18 iznosila je 47,2% (95% CI: 33,5; 58,2).
Gardasil suspension for injection in a pre-filled syringe
Gardasil suspenzija za injekciju u napunjenoj štrcaljki i.m. primjena
Gardasil can be administered according to a 2-dose schedule: - First injection: at chosen date - Second injection: 6 months after first injection If the second vaccine dose is administered earlier than 6 months after the first dose, a third dose should always be administered.
Gardasil se također može primijeniti i prema rasporedu za 3 doze: Prva injekcija: na odabrani datum
Gardasil, suspension for injection Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
Gardasil, suspenzija za injekciju cjepivo protiv humanog papilomavirusa [tipova 6, 11, 16, 18] (rekombinantno, adsorbirano)
20 single dose vials, 0.5 ml each.
10 jednodoznih bočica, svaka 0,5 ml. 20 jednodoznih bočica, svaka 0,5 ml.
Gardasil, suspension for injection - pre-filled syringe with 1 needle, pack of 1, 10, 20
Gardasil, suspenzija za injekciju- napunjena štrcaljka s 1 iglom, pakiranje od 1, 10, 20
Gardasil, suspension for injection in a pre-filled syringe Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
Gardasil, suspenzija za injekciju u napunjenoj štrcaljki cjepivo protiv humanog papilomavirusa [tipova 6, 11, 16, 18] (rekombinantno, adsorbirano)
- Gardasil is available in a pre-filled syringe ready to use for intramuscular injection (IM), preferably in the deltoid area of the upper arm. - If 2 needles of different lengths are provided in the pack, choose the appropriate needle to ensure an IM administration depending on your patient's size and weight.
- Gardasil je dostupan u napunjenoj štrcaljki spremnoj za primjenu u mišić (i.m.), poželjno u deltoidno područje nadlaktice.
Patients were followed for up to 4 years (median 3.6 years).
Bolesnici su bili praćeni do 4 godine (medijan = 3,6 godina) Napomena: Točke procjene i intervali pouzdanosti prilagođeni su osobi-vremenu praćenja.
Gardasil suspension for injection Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
Gardasil suspenzija za injekciju cjepivo protiv humanog papilomavirusa [tipova 6, 11, 16, 18] (rekombinantno, adsorbirano)
Among women with an abnormal Pap test at Day 1 who were already infected with the relevant vaccine HPV types at Day 1, no vaccine efficacy was observed.
Nije zamijećeno zaštitno djelovanje cjepiva među ženama s patološkim nalazima Papa testa prvoga dana ispitivanja koje su pri ulasku u ispitivanje već bile inficirane odgovarajućim tipovima HPV-a sadržanim u cjepivu.
• the efficacy of Gardasil against HPV 6-, 11-, 16-, 18-related genital warts was 99.0% (95% CI:
• djelotvornost cjepiva Gardasil protiv genitalnih bradavica povezanih s HPV-om tipova 6, 11, 16 i 18 iznosila je 99,0% (95% CI: 96,2; 99,9).
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 od 1 EU/1/06/357/008 - pakiranje od 10 EU/1/06/357/021 - pakiranje od 20
adsorbed on amorphous aluminium hydroxyphosphate sulphate adjuvant (0.225 milligrams Al).
L1 protein u obliku čestica nalik virusu proizvedenih u stanicama kvasca (Saccharomyces cerevisiae CANADE 3C-5 (soj 1895)) tehnologijom rekombinantne DNA. adsorbiran na amorfni aluminijev hidroksifosfat sulfat adjuvans (0,225 miligrama Al).
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 od 1 EU/1/06/357/004 - pakiranje od 10 EU/1/06/357/019 - pakiranje od 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 od 1 EU/1/06/357/002- pakiranje od 10 EU/1/06/357/018- pakiranje od 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 od 1 EU/1/06/357/006 - pakiranje od 10 EU/1/06/357/020 - pakiranje od 20
Gardasil suspension for injection in a pre-filled syringe Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
Gardasil suspenzija za injekciju u napunjenoj štrcaljki cjepivo protiv humanog papilomavirusa [tipova 6, 11, 16, 18] (rekombinantno, adsorbirano)
Note: point estimates and confidence intervals are adjusted for person-time of follow-up.
***Bolesnici su bili praćeni do 4 godine (medijan 3,6 godina) Napomena: Točke procjene i intervali pouzdanosti prilagođeni su osobi-vremenu praćenja.
1 dose vial, 0.5 ml.
Jednodozna bočica, 0,5 ml.
Not known Hypersensitivity reactions including anaphylactic/anaphylactoid reactions*
Infekcije i infestacije nepoznato celulitis na mjestu injiciranja * Poremećaji krvi i limfnog sustava nepoznato idiopatska trombocitopenična purpura*, limfadenopatija* Poremećaji imunološkog sustava nepoznato reakcije preosjetljivosti uključujući anafilaktičke/anafilaktoidne reakcije*
The reasoning being that:
Razlog je sljedeći:
Qualitative and quantitative composition
Kvalitativni i kvantitativni sastav
Meat and offal: 107 days.
Meso i iznutrice: 107 dana.
Finally, consideration has been given to the analytical methods that were used.
Naposljetku, razmotrene su primijenjene analitičke metode.
The differences between the two residues studies have been considered.
Razmatrane su razlike između dvaju ispitivanja o reziduima.
Animal species
Vrsta životinj
Information was received regarding the composition of the affected products (n = 5).
Zaprimljene su informacije o sastavu predmetnih lijekova (n = 5).
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.
Kvaliteta, sigurnost ciljane životinje, sigurnost korisnika, rizik za okoliš i otpornost na parazite za predmetne veterinarsko-medicinske proizvode nije procijenjena u ovom arbitražnom postupku.
A 41-day withdrawal period was determined, following statistical evaluation of the residues depletion data using the WT1.4 software.
Određeno je razdoblje karencije u trajanju od 41 dan, nakon statističke ocjene podataka o izlučivanju rezidua s pomoću softvera WT1.4.
There were no residues depletion data provided for the last two products mentioned.
Nije bilo podataka o izlučivanju rezidua za posljednja dva navedena lijeka.
Do not use within 1 year prior to the first lambing in ewes intended to produce milk for human consumption.
Ne primjenjivati unutar jedne godine prije prvog janjenja u ovaca namijenjenih za proizvodnju mlijeka za prehranu ljudi.
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.
Sporo se oslobađa iz plazme i vrlo se sporo metabolizira te se stoga dugo zadržava u cirkulaciji; vrijeme polueliminacije iz plazme u ovaca iznosi 22,7 dana.
The limit of detection for muscle was also lower in Study 1 (<2 µg/kg) than in Study 2 (492 µg/kg).
Granica detekcije u mišiću ujedno je bila niža u 1. ispitivanju (<2 µg/kg) nego u 2. ispitivanju (492 µg/kg).
The last product is formulated with a large percentage of glycerol formal.
Posljednji lijek formuliran je s velikim postotkom glicerol formala.
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 nositelja odobrenja za stavljanje u promet dostavila su izvješća s detaljima o potvrđivanju primijenjene analitičke metode, a karakteristike učinkovitosti ponajprije su opisane u skladu s postojećim standardima.
Not authorised for use in ewes producing milk for human consumption including during the dry period.
Nije odobrena primjena u ovaca koje proizvode mlijeko za prehranu ljudi, uključujući tijekom suhostaja.
The two products used in the studies include almost the same excipients, but in different quantities.
Dva lijeka primijenjena u ispitivanjima sadržavaju gotovo iste pomoćne tvari, ali u različitim količinama.
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.
Većina (90 %) doze klozantela izlučuje se u nepromijenjenom stanju u žuči/fecesu nakon intramuskularne primjene, od čega samo 10 % unutar 48 sati, nakon čega se brzina dalje smanjuje tako da se svaki dan eliminira 1 % - 2 % doze.
This is considered to be an important parameter affecting the residues at the injection site.
Smatra se da je to važan parametar koji utječe na rezidue na mjestu primjene injekcije.
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.
Druga (nacionalno odobrena) verzija otopine za injekciju Flukiver odobrena je u Francuskoj od 1981.; odobrenje za stavljanje u promet ovog lijeka izmijenjeno je 2016., a razdoblje karencije za ovce (meso i iznutrice) povećano je sa 77 dana na 107 dana zbog podataka dobivenih tijekom postupka izmjene.
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 anthelmintik, sintetski antiparazitski agens djelotvoran protiv jetrenih parazita, hematofagnih nematoda i stadija ličinaka nekih člankonožaca u ovaca i goveda.
List of the names, pharmaceutical form, strengths of the veterinary medicinal products, animal species, route of administration and marketing authorisation holders in the Member States
Popis naziva, farmaceutskih oblika, jačina veterinarskomedicinskih proizvoda, vrsta životinja, putova primjene i nositelja odobrenja za stavljanje lijeka u promet u državama članicama
However, there are some significant differences between this and the other product formulations that are in the scope of this referral procedure.
Međutim, postoje znatne razlike između te formulacije i drugih formulacija lijeka obuhvaćenih ovim arbitražnim postupkom.
• with regard to the need for a maximum injection volume to be recommended in case of any difference in depletion on injection site residues, the CVMP does not consider it necessary to restrict the use of these products in this way.
• s obzirom na potrebu za preporukom najvećeg dopuštenog volumena injekcije u slučaju bilo kakve razlike u izlučivanju rezidua na mjestu primjene injekcije, CVMP ne smatra da je potrebno ograničiti primjenu tih lijekova na taj način.
The UK therefore considered that it is necessary to refer the matter to the CVMP in the interests of protecting consumer safety in the Union and requested the Committee to review all available residue depletion data and recommend withdrawal periods for sheep (meat and offal).
Ujedinjena Kraljevina stoga je smatrala da je potrebno uputiti predmet CVMP-u u interesu zaštite sigurnosti potrošača u Uniji te je zatražila od Odbora da preispita sve dostupne podatke o izlučivanju rezidua i preporuči razdoblje karencije za ovce (meso i iznutrice).
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.
Preporučene doze jesu 2,5 mg ili 5 mg klozantela po kg tjelesne težine za goveda i ovce, ovisno o vrstama parazita i/ili životnom stadiju parazita u vrijeme liječenja.
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).
Podatcima o izlučivanju rezidua za markersko tkivo, odnosno jetru, ne omogućuje se statističko određivanje razdoblja karencije (nije ispunjena pretpostavka normalne razdiobe pogrešaka).
When administered parenterally, closantel is absorbed relatively quickly into the systemic circulation (Tmax = 8 - 24 h) and is highly bound to albumin in the plasma.
Kad se primjenjuje parenteralno, klozantel se relativno brzo apsorbira u sistemsku cirkulaciju (Tmax = 8 - 24 h) i ima visok postotak vezanja za albumin u plazmi.
The proposed sheep meat withdrawal period for the generic product, Santiola, was 77 days, in line with the Irish reference product (although the target species ‘sheep' was removed from the reference product during the application procedure for Santiola), but not in accordance with the data provided by France during the procedure.
Predloženo razdoblje karencije ovčjeg mesa za generički lijek Santiola iznosilo je 77 dana, u skladu s irskim referentnim lijekom (iako je ciljna vrsta „ovca” uklonjena iz referentnog lijeka tijekom postupka podnošenja zahtjeva za lijek Santiola), ali ne u skladu s podatcima koje je dostavila Francuska tijekom postupka.
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.
Budući da djelotvornost predmetnih lijekova u ovaca nije posebno procijenjena u okviru ovog arbitražnog postupka, lijekovi koji se procjenjuju smatraju se djelotvornima u liječenju i prevenciji infestacija navedenim parazitima.
The CVMP considered whether it would be necessary to restrict the volume of injection, to mitigate any uncertainties around the effect of formulation differences at the injection sites.
CVMP je razmotrio bi li trebalo ograničiti volumen injekcije kako bi se ublažile bilo kakve nesigurnosti u pogledu učinka razlike u formulaciji na mjestu primjene injekcije.
However, considering the results of this pilot study, and the limited information that they provide, this conclusion might not be adequate, as the residue concentrations in the sampled tissues did not fall below the respective MRLs; therefore, it was not possible to know which would be the withdrawal period determining tissue from these data.
Međutim, uzimajući u obzir rezultate tog pilotispitivanja i ograničene informacije koje ta ispitivanja pružaju, ovaj zaključak možda nije prikladan s obzirom na to da koncentracije rezidua u uzorkovanim tkivima nisu bile ispod najvećih dopuštenih količina rezidua; stoga iz tih podataka nije bilo moguće utvrditi s pomoću kojeg se tkiva određuje razdoblje karencije.
The reference product is Flukiver 50 mg/ml Solution for Injection, which has been authorised in various Member States since 1989.
Referentni lijek je otopina za injekciju Flukiver 50 mg/ml, odobren u raznim državama članicama od 1989.
An additional risk mitigation measure of restricting the maximum injection volumes was considered by the CVMP, but ultimately it was decided that this was not required to ensure consumer safety.
CVMP je razmatrao dodatnu mjeru ublažavanja rizika u smislu ograničavanja najvećih dopuštenih volumena injekcije, ali je na kraju odlučeno da to nije potrebno kako bi se zajamčila sigurnost potrošača.
In addition, different breeds of sheep were used in each of the studies provided.
Osim toga, svako od navedenih ispitivanja provedeno je na različitim vrstama ovaca.
One of these products (‘Flukiver 5%') was used in the pivotal residues study, Study 1.
Jedan od tih lijekova („Flukiver 5 %”) primijenjen je u glavnom ispitivanju o reziduima, odnosno 1. ispitivanju.
The study was conducted in 2016 with 20 treated animals (five mixed-sex groups of four animals) and a control group consisting of two untreated animals.
Ispitivanje je provedeno 2016. na 20 liječenih životinja (pet skupina od četiri životinje obaju spolova) i kontrolnoj skupini koja se sastojala od dvije neliječene životinje.