FrancophonIA/ELRC3.0 huggingface dataset:
English: Each hard capsule contains 93 mg of lactose (as monohydrate).
Slovenian: Pomožna snov z znanim učinkom: Ena trda kapsula vsebuje 93 mg laktoze (v obliki monohidrata).
English: Administer IBRANCE with caution to patients with moderate or severe renal impairment, with close monitoring of signs of toxicity (see sections 4.2 and 5.2).
Slovenian: Pri bolnikih z zmerno ali hudo okvaro ledvic je treba zdravilo IBRANCE uporabljati previdno in skrbno spremljati znake toksičnosti (glejte poglavji 4.2 in 5.2).
English: A reduction in the risk of disease progression or death in the palbociclib plus fulvestrant arm was observed in all individual patient subgroups defined by stratification factors and baseline characteristics.
Slovenian: V skupini s palbociklibom in fulvestrantom so pri vsaki posamezni podskupini bolnic, opredeljeni glede na stratifikacijske dejavnike in izhodiščne značilnosti, opazili zmanjšanje tveganja za napredovanje bolezni ali smrt.
English: What IBRANCE looks like and contents of the pack - IBRANCE 75 mg is supplied as opaque, hard capsules, with a light orange body (printed “PBC 75” in white) and a light orange cap (printed “Pfizer” in white).
Slovenian: Izgled zdravila IBRANCE in vsebina pakiranja Zdravilo IBRANCE 75 mg je na voljo v obliki neprozornih, trdih kapsul s svetlo oranžnim telesom (z belo natisnjeno oznako “PBC 75”) in svetlo oranžnim pokrovčkom (z belo natisnjeno oznako “Pfizer”).
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA
English: Therefore, men may consider sperm preservation before taking IBRANCE.
Slovenian: Pred jemanjem zdravila IBRANCE morajo moški zato razmisliti o shranjevanju sperme.
English: Excretion of unchanged palbociclib in faeces and urine was 2% and 7% of the administered dose, respectively.
Slovenian: V blato in urin se je v obliki nespremenjenega palbocikliba izločilo 2 % oziroma 7 % danega odmerka.
English: All Grades n (%)
Slovenian: Priporočeni izraz n (%)
English: GENERAL CLASSIFICATION FOR SUPPLY INSTRUCTIONS ON USE
Slovenian: OZNAČEVANJE IN NAVODILO ZA UPORABO
English: IBRANCE 100 mg hard capsules
Slovenian: IBRANCE 100 mg trde kapsule
English: The NOEL for palbociclib-related carcinogenicity effects was 10 mg/kg/day (approximately 2 times the human clinical exposure based on AUC) and
Slovenian: Vrednost NOEL za s palbociklibom povezane kancerogene učinke je bila pri samcih 10 mg/kg/dan (približno 2-kratnik klinične izpostavljenosti pri ljudeh na osnovi vrednosti AUC), pri samicah pa 200 mg/kg/dan (približno 4-kratnik klinične izpostavljenosti pri ljudeh na osnovi vrednosti AUC).
English: ANC=absolute neutrophil counts; CTCAE=Common Terminology Criteria for Adverse Events; LLN=lower limit of normal.
Slovenian: ANC = absolutno število nevtrofilcev; CTCAE = merila NCI za poenoteno terminologijo neželenih dogodkov (National Cancer Institute Common Terminology Criteria for Adverse Events); SMN = spodnja meja normalne vrednosti a. Preglednica velja za vse hematološke neželene učinke, z izjemo limfopenije (razen če je povezana s kliničnimi dogodki, npr. oportunističnimi okužbami).
English: 125 mg/day
Slovenian: 125 mg/dan prvo zmanjšanje odmerka
English: Infections have been reported at a higher rate in patients treated with IBRANCE in randomised clinical studies compared to patients treated in the respective comparator arm. Grade 3 and Grade 4 infections occurred respectively in 4.5% and 0.7% of patients treated with IBRANCE in any combination (see section 4.8).
Slovenian: Okužbe stopnje 3 oz. 4 so se pojavile pri 4,5 % oziroma 0,7 % bolnikov, zdravljenih z zdravilom IBRANCE v katerikoli kombinaciji (glejte poglavje 4.8).
English: Concomitant use of strong CYP3A inhibitors during treatment with palbociclib should be avoided.
Slovenian: Med zdravljenjem s palbociklibom se je treba izogibati sočasni uporabi močnih zaviralcev CYP3A.
English: Thus, men may consider sperm preservation prior to beginning therapy with IBRANCE.
Slovenian: Pred začetkom zdravljenja z zdravilom IBRANCE naj moški zato razmislijo o hrambi sperme.
English: OR* [% (95% CI)] OR* measurable disease [% (95% CI)] CBR* [% (95% CI)] N=number of patients; CI=confidence interval; NE=not estimable; OR=objective response; CBR=clinical benefit response; PFS=progression-free survival.
Slovenian: OR* [% (95 % IZ)] OR* merljiva bolezen [% (95 % IZ)] 60,7 (55,2; 65,9) 49,1 (41,4; 56,9) 62,4 (57,0; 67,6) 49,7 (42,0; 57,4) CBR* [% (95 % IZ)] n = število bolnic; IZ = interval zaupanja; NE = ni mogoče oceniti; OR = objektivni odziv; CBR = odziv klinične koristi; PFS = preživetje brez napredovanja bolezni.
English: IBRANCE 75 mg hard capsules
Slovenian: IBRANCE 75 mg trde kapsule
English: Rashh Alopecia
Slovenian: • suh kašelj,
English: Interstitial Lung Disease (narrow).
Slovenian: poizvedbe za intersticijsko bolezen pljuč (ozko iskanje).
English: 0.563 (0.461, 0.687), p<0.000001
Slovenian: 0,576 (0,463; 0,718), p < 0,000001 0,563 (0,461; 0,687), p < 0,000001
English: An increased incidence of a skeletal variation (increased incidence of a rib present at the seventh cervical vertebra) at ≥100 mg/kg/day was observed in rats.
Slovenian: Pri podganah so pri odmerku ≥ 100 mg/kg/dan opazili povečano incidenco skeletnih sprememb (povečana incidenca prisotnosti rebra na sedmem vratnem vretencu).
English: Placebo plus letrozole (N=110)
Slovenian: Placebo in letrozol (n = 110)
English: 0.653 (0.505, 0.844), p=0.000532
Slovenian: 0,653 (0,505; 0,844), p = 0,000532 0,611 (0,485; 0,769), p = 0,000012
English: You should not breast-feed while taking IBRANCE.
Slovenian: Med zdravljenjem z zdravilom IBRANCE ne smete dojiti.
English: Placebo plus letrozole (N=112)
Slovenian: Placebo in letrozol (n = 112)
English: IBRANCE 75 mg hard capsules IBRANCE 100 mg hard capsules IBRANCE 125 mg hard capsules palbociclib
Slovenian: IBRANCE 75 mg trde kapsule IBRANCE 100 mg trde kapsule IBRANCE 125 mg trde kapsule palbociklib
English: Coadministration of multiple 400 mg daily doses of modafinil, a moderate CYP3A inducer, with a single 125 mg IBRANCE dose decreased palbociclib AUCinf and Cmax by 32% and 11%, respectively, relative to a single 125 mg IBRANCE dose given alone.
Slovenian: Sočasna uporaba večkratnih dnevnih odmerkov 400 mg modafinila, zmernega induktorja CYP3A, skupaj z enkratnim odmerkom 125 mg zdravila IBRANCE je zmanjšala AUCinf in cmax palbocikliba za 32 % oziroma 11 % v primerjavi s samostojno uporabo enkratnega odmerka 125 mg palbocikliba.
English: Each hard capsule contains 56 mg of lactose (as monohydrate).
Slovenian: Pomožna snov z znanim učinkom: Ena trda kapsula vsebuje 56 mg laktoze (v obliki monohidrata).
English: No dose adjustment of IBRANCE is required for patients with mild or moderate hepatic impairment (Child-Pugh classes A and B).
Slovenian: Pri bolnikih z blago ali zmerno okvaro jeter (razreda A in B po klasifikaciji Child-Pugh) prilagajanje odmerka zdravila IBRANCE ni potrebno.
English: Dry eye
Slovenian: suha koža
English: Each hard capsule contains 74 mg of lactose (as monohydrate).
Slovenian: Pomožna snov z znanim učinkom: Ena trda kapsula vsebuje 74 mg laktoze (v obliki monohidrata).
English: EU/1/16/1147/005 (21 hard capsules) EU/1/16/1147/009 (63 hard capsules)
Slovenian: EU/1/16/1147/005 (21 trdih kapsul) EU/1/16/1147/009 (63 trdih kapsul)
English: Palbociclib induced micronuclei via an aneugenic mechanism in Chinese Hamster Ovary cells in vitro and in the bone marrow of male rats at doses ≥100 mg/kg/day.
Slovenian: Pri odmerkih ≥ 100 mg/kg/dan je palbociklib izzval nastajanje mikrojeder preko anevgenega mehanizma v ovarijskih celicah kitajskega hrčka in vitro in v kostnem mozgu samcev podgan.
English: Ovarian ablation or suppression with an LHRH agonist is mandatory when pre/perimenopausal women are administered IBRANCE in combination with an aromatase inhibitor, due to the mechanism of action of aromatase inhibitors.
Slovenian: Kadar zdravilo IBRANCE uporabljamo v kombinaciji z zaviralcem aromataze pri ženskah v predoziroma perimenopavzi, je zaradi mehanizma delovanja zaviralca aromataze obvezna ovarijska ablacija ali supresija z agonistom LHRH.
English: 100 mg/day
Slovenian: 100 mg/dan drugo zmanjšanje odmerka
English: Tell your doctor, pharmacist or nurse if you experience signs or symptoms of an infection, such as chills or fever.
Slovenian: Če opazite znake ali simptome okužbe, kot sta mrzlica ali vročina, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: EU/1/16/1147/003 (21 hard capsules) EU/1/16/1147/008 (63 hard capsules)
Slovenian: EU/1/16/1147/003 (21 trdih kapsul) EU/1/16/1147/008 (63 trdih kapsul)
English: IBRANCE 125 mg hard capsules
Slovenian: IBRANCE 125 mg trde kapsule
English: Following oral administration of a single 125 mg dose of [14C]palbociclib to humans, the major primary metabolic pathways for palbociclib involved oxidation and sulphonation, with acylation and glucuronidation contributing as minor pathways.
Slovenian: C] palbocikliba ljudem so glavne primarne presnovne poti za palbociklib vključevale oksidacijo in sulfonacijo, acilacija in glukoronidacija pa sta prispevali kot manj pomembni poti.
English: Coadministration of multiple 200 mg doses of itraconazole with a single 125 mg palbociclib dose increased palbociclib total exposure (AUCinf) and the peak concentration (Cmax) by approximately 87% and 34%, respectively, relative to a single 125 mg palbociclib dose given alone.
Slovenian: Sočasna uporaba večkratnih odmerkov 200 mg itrakonazola skupaj z enkratnim odmerkom 125 mg palbocikliba je povečala skupno izpostavljenost palbociklibu (AUCinf) in največjo koncentracijo (cmax) za približno 87 % oziroma 34 % v primerjavi s samostojno uporabo enkratnega odmerka 125 mg palbocikliba.
English: There were no effects on oestrous cycle (female rats) or mating and fertility in rats (male or female) in nonclinical reproductive studies.
Slovenian: Predklinične študije sposobnosti razmnoževanja na podganah niso pokazale nobenih učinkov na cikel estrusa (pri samicah podgan) ali parjenje in plodnost (pri samcih ali samicah).
English: Ibrance plus Letrozole or Fulvestrant
Slovenian: Zdravilo IBRANCE in letrozol ali fulvestrant
English: IBRANCE plus letrozole (N=230)
Slovenian: Zdravilo IBRANCE in letrozol (n = 230)
English: - IBRANCE 75 mg hard capsule: each capsule contains 75 mg palbociclib.
Slovenian: IBRANCE 75 mg trde kapsule: ena kapsula vsebuje 75 mg palbocikliba.
English: Palbociclib is considered to have the potential to impair reproductive function and fertility in male humans based on nonclinical findings in rats and dogs.
Slovenian: Na podlagi predkliničnih ugotovitev pri podganah in psih velja, da palbociklib potencialno lahko okvari sposobnost razmnoževanja in plodnost pri moških.
English: Progression-free survival (PFS) Number of events (%) Median [months (95% CI)] Hazard ratio (95% CI) and p-value
Slovenian: Preživetje brez napredovanja bolezni (PFS) število dogodkov (%) mediana [meseci (95 % IZ)] razmerje ogroženosti (95 % IZ) in vrednost p
English: Permanently discontinue IBRANCE in patients with severe ILD or pneumonitis (see section 4.2).
Slovenian: Pri bolnikih s hudo ILD ali pnevmonitisom je treba zdravljenje z zdravilom IBRANCE trajno prekiniti (glejte poglavje 4.2).
English: - IBRANCE 100 mg hard capsule: each capsule contains 100 mg palbociclib.
Slovenian: IBRANCE 100 mg trde kapsule: ena kapsula vsebuje 100 mg palbocikliba.
English: - IBRANCE 125 mg hard capsule: each capsule contains 125 mg palbociclib.
Slovenian: IBRANCE 125 mg trde kapsule: ena kapsula vsebuje 125 mg palbocikliba.
English: Drug-drug interaction between palbociclib and letrozole
Slovenian: Medsebojna delovanja med palbociklibom in letrozolom
English: Coadministration of multiple 600 mg doses of rifampin with a single 125 mg palbociclib dose decreased palbociclib AUCinf and Cmax by 85% and 70%, respectively, relative to a single 125 mg palbociclib dose given alone.
Slovenian: Sočasna uporaba večkratnih odmerkov 600 mg rifampicina skupaj z enkratnim odmerkom 125 mg palbocikliba je zmanjšala AUCinf in cmax palbocikliba za 85 % oziroma 70 % v primerjavi s samostojno uporabo enkratnega odmerka 125 mg palbocikliba.
English: IBRANCE 100 mg hard capsules Each hard capsule contains 100 mg of palbociclib.
Slovenian: IBRANCE 100 mg trde kapsule Ena trda kapsula vsebuje 100 mg palbocikliba.
English: Talk to your doctor, pharmacist or nurse before taking IBRANCE.
Slovenian: Pred začetkom jemanja zdravila IBRANCE se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: IBRANCE 125 mg hard capsules Each hard capsule contains 125 mg of palbociclib.
Slovenian: IBRANCE 125 mg trde kapsule Ena trda kapsula vsebuje 125 mg palbocikliba.
English: IBRANCE 75 mg hard capsules Each hard capsule contains 75 mg of palbociclib.
Slovenian: IBRANCE 75 mg trde kapsule Ena trda kapsula vsebuje 75 mg palbocikliba.
English: Under fasting conditions, the coadministration of multiple doses of the proton pump inhibitor (PPI) rabeprazole with a single dose of 125 mg IBRANCE decreased palbociclib AUCinf and Cmax by 62% and 80%, respectively.
Slovenian: Na tešče je sočasna uporaba večkratnih odmerkov PPI, rabeprazola, skupaj z enkratnim odmerkom 125 mg zdravila IBRANCE zmanjšala AUCinf in cmax palbocikliba za 62 % oziroma 80 %.
English: - IBRANCE 125 mg is supplied as opaque, hard capsules, with a caramel body (printed “PBC 125” in white) and a caramel cap (printed “Pfizer” in white).
Slovenian: Zdravilo IBRANCE 125 mg je na voljo v obliki neprozornih, trdih kapsul s karamelnim telesom (z belo natisnjeno oznako “PBC 125”) in karamelnim pokrovčkom (z belo natisnjeno oznako “Pfizer”).
English: Opaque, hard capsule, with a light orange body (printed “PBC 75” in white) and a light orange cap (printed “Pfizer” in white).
Slovenian: Neprozorna, trda kapsula s svetlo oranžnim telesom (z belo natisnjeno oznako “PBC 75”) in svetlo oranžnim pokrovčkom (z belo natisnjeno oznako “Pfizer”).
English: IBRANCE plus letrozole (N=214)
Slovenian: Zdravilo IBRANCE in letrozol (n = 214)
English: Hazard ratio [(95% CI) and p-value]
Slovenian: razmerje ogroženosti [(95 % IZ) in vrednost p]
English: No dose adjustments are required for coadministration of palbociclib with moderate CYP3A inducers (see section 4.5).
Slovenian: Pri sočasni uporabi palbocikliba z zmernimi induktorji CYP3A prilagajanje odmerka ni potrebno (glejte poglavje 4.5).
English: f Thrombocytopenia includes the following PTs: Thrombocytopenia, Platelet count decreased.
Slovenian: f. Trombocitopenija vključuje naslednje PT: trombocitopenija, zmanjšanje števila trombocitov.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL - 100 MG CAPSULES
Slovenian: NALEPKA NA PLASTENKI - 100 MG KAPSULE
English: - IBRANCE 100 mg is supplied as opaque, hard capsules, with a light orange body (printed “PBC 100” in white) and a caramel cap (printed “Pfizer” in white).
Slovenian: Zdravilo IBRANCE 100 mg je na voljo v obliki neprozornih, trdih kapsul s svetlo oranžnim telesom (z belo natisnjeno oznako “PBC 100”) in karamelnim pokrovčkom (z belo natisnjeno oznako “Pfizer”).
English: How to store IBRANCE
Slovenian: Shranjevanje zdravila IBRANCE
English: Opaque, hard capsule, with a caramel body (printed “PBC 125” in white) and a caramel cap (printed “Pfizer” in white).
Slovenian: Neprozorna, trda kapsula s karamelnim telesom (z belo natisnjeno oznako “PBC 125”) in karamelnim pokrovčkom (z belo natisnjeno oznako “Pfizer”).
English: OR [%, (95% CI)] TTR, Median [months (range)]
Slovenian: TTR, mediana [meseci (razpon)]
English: The dose may be lowered to one of the other available strengths 100 mg or 75 mg. Take IBRANCE once a day at about the same time every day with food, preferably a meal.
Slovenian: Zdravilo IBRANCE vzemite enkrat na dan, vsak dan ob približno istem času, skupaj s hrano, priporočljivo z obrokom.
English: Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia.
Slovenian: Pri bolnikih, pri katerih se razvije nevtropenija stopnje 3 ali 4, je priporočljiva prekinitev odmerjanja,
English: NAME OF THE MEDICINAL PRODUCT IBRANCE 100 mg hard capsules palbociclib
Slovenian: IBRANCE 100 mg trde kapsule palbociklib
English: Discuss contraception with your doctor if there is any possibility that you or your partner may become pregnant.
Slovenian: Če obstaja možnost, da lahko zanosite ali lahko zanosi vaša partnerka, se posvetujte z zdravnikom glede kontracepcije.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 125 MG CAPSULES
Slovenian: NALEPKA NA PLASTENKI - 125 MG KAPSULE
English: Opaque, hard capsule, with a light orange body (printed “PBC 100” in white) and a caramel cap (printed “Pfizer” in white).
Slovenian: Neprozorna, trda kapsula s svetlo oranžnim telesom (z belo natisnjeno oznako “PBC 100”) in karamelnim pokrovčkom (z belo natisnjeno oznako “Pfizer”).
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL - 75 MG CAPSULES
Slovenian: NALEPKA NA PLASTENKI - 75 MG KAPSULE
English: NAME OF THE MEDICINAL PRODUCT IBRANCE 125 mg hard capsules palbociclib
Slovenian: IBRANCE 125 mg trde kapsule palbociklib
English: Appropriate monitoring should be performed (see sections 4.2 and 4.8).
Slovenian: zmanjšanje odmerka ali odložitev začetka ciklov zdravljenja, bolnike pa je treba ustrezno spremljati (glejte poglavji 4.2 in 4.8).
English: Palbociclib did not prolong the QTc to any clinically relevant extent at the recommended dose of 125 mg daily (Schedule 3/1).
Slovenian: Ob priporočenem odmerku 125 mg na dan (shema 3/1) palbociklib ni podaljšal intervala QTc v klinično pomembnem obsegu.
English: The majority of the material was excreted as metabolites.
Slovenian: Učinkovina se je večinoma izločila v obliki presnovkov.
English: In particular, the following may increase the risk of side effects with IBRANCE:
Slovenian: Tveganje za pojav neželenih učinkov zdravila IBRANCE lahko še zlasti povečajo naslednja zdravila:
English: NAME OF THE MEDICINAL PRODUCT IBRANCE 75 mg hard capsules palbociclib
Slovenian: IBRANCE 75 mg trde kapsule palbociklib
English: - use of preparations containing St. John's Wort should be avoided while you are taking IBRANCE.
Slovenian: -v času jemanja zdravila IBRANCE ne jemljite pripravkov, ki vsebujejo šentjanževko.
English: Dry skin General disorders and administration site conditions
Slovenian: Bolezni kože in podkožja zelo pogosti izpuščaj alopecija
English: • chest pain
Slovenian: • bolečina v prsnem košu.
English: You should avoid becoming pregnant while taking IBRANCE.
Slovenian: Med jemanjem zdravila IBRANCE se izogibajte zanositvi.
English: Palbociclib is a weak, time-dependent inhibitor of CYP3A following daily 125 mg dosing at steady state.
Slovenian: Po dnevnem odmerjanju 125 mg je palbociklib v stanju dinamičnega ravnovesja šibek, časovnoodvisen zaviralec CYP3A.
English: * Adverse Drug Reaction (ADR) identified post-marketing.
Slovenian: Neželeni učinek, ugotovljen v obdobju trženja zdravila.
English: Patients were well matched for baseline demographics and prognostic characteristics between the palbociclib plus letrozole arm and the placebo plus letrozole arm.
Slovenian: Bolnice skupine s palbociklibom in letrozolom in skupine s placebom in letrozolom so bile precej enakovredne glede izhodiščnih demografskih podatkov in prognostičnih značilnosti.
English: EU/1/16/1147/007 (63 hard capsules)
Slovenian: EU/1/16/1147/001 (21 trdih kapsul) EU/1/16/1147/007 (63 trdih kapsul)
English: Patients were well matched for baseline demographics and prognostic characteristics between the palbociclib plus fulvestrant arm and the placebo plus fulvestrant arm.
Slovenian: Bolnice skupine s palbociklibom in fulvestrantom in skupine s placebom in fulvestrantom so bile precej enakovredne glede izhodiščnih demografskih podatkov in prognostičnih značilnosti.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 125 mg palbociclib.
Slovenian: Ena kapsula vsebuje 125 mg palbocikliba.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 100 mg palbociclib.
Slovenian: Ena kapsula vsebuje 100 mg palbocikliba.
English: Decreased appetite Nervous system disorders
Slovenian: Bolezni prebavil zelo pogosti stomatitis navzea diareja bruhanje
English: Netherlands, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Norway, Poland, Portugal and Spain.
Slovenian: Nizozemska, Avstrija, Belgija, Danska, Finska, Francija, Nemčija, Grčija, Madžarska, Irska, Italija, Luksemburg, Norveška, Poljska, Portugalska in Španija.
English: The indication proposed cannot be accepted.
Slovenian: Predlagane indikacije ni mogoče sprejeti.
English: The youngest horse included in the field trial was 16 months old.
Slovenian: Najmlajši konj, ki je bil vključen v terensko raziskavo, je bil star 16 mesecev.
English: Product invented name
Slovenian: Izmišljeno ime izdelka
English: The test procedure did not follow the methods for a controlled or critical test.
Slovenian: Postopek testiranja ni upošteval metod za kontrolirano ali kritično raziskavo.
English: Retreatment should be done according to the epidemiological situation, but not at less than 30 days interval
Slovenian: Ponovno zdravljenje se naj izvaja v skladu z epidemiološko situacijo, vendar ne v intervalu, ki je krajši od 30 dni.
English: Efficacy should have been investigated at the lowest dose recommended.
Slovenian: Učinkovitost bi morala biti preučena pri najmanjšem priporočenem odmerku.
English: Thus the proposal from the MAH, although scientifically justified, remains practically very questionable.
Slovenian: Zato ostaja predlog imetnika dovoljenja za promet, čeprav je znanstveno utemeljen, v praksi dejansko zelo vprašljiv.
English: The wording of the proposal for Section 4.2 of the SPC is not supported.
Slovenian: Predlagano besedilo poglavja 4.2 SPC ni utemeljeno.
English: Frequency and route of administration
Slovenian: Pogostost in način uporabe
English: Based on the critical test performed, the efficacy against Parascaris was 100%.
Slovenian: Na podlagi opravljene kritične raziskave je bila učinkovitost proti rodu Parascaris 100 %.
English: The WAAVP guidelines state that, for a field trial, data from at least 100 horses should be obtained in each of 3 different areas.
Slovenian: Smernice združenja WAAVP navajajo, da je treba pri terenskih raziskavah zbrati podatke za najmanj 100 konj za vsako od 3 različnih področij.
English: A single field study was submitted in support of the efficacy of the product.
Slovenian: Predložena je bila ena terenska raziskava, ki je utemeljevala učinkovitost izdelka.
English: The relative egg reductions calculations do not reflect these findings, particularly regarding P. equorum.
Slovenian: Izračuni relativnega zmanjšanja števila jajčec ne odražajo teh izsledkov, še zlasti ne pri vrsti P. equorum.
English: The results for efficacy of Eqvalan measured this way were also below 90%.
Slovenian: Tudi rezultati učinkovitosti zdravila Eqvalan, ki so bili izmerjeni na ta način, so bili pod 90 %.
English: ANNEX III CONDITION FOR THE LIFTING OF THE SUSPENSION
Slovenian: DODATEK III POGOJ ZA PREKLIC UMIKA
English: Recommended dose
Slovenian: Priporočen odmerek
English: - This was not a multicentric trial.
Slovenian: - Nobena raziskava ni bila multicentrična.
English: This has not been shown, and in fact the indication is so restricted that the product could not be used for routine deworming in the horse.
Slovenian: To ni bilo dokazano, pa tudi dejansko je indikacija tako omejena, da izdelka ne bi bilo mogoče uporabljati za rutinsko zatiranje notranjih zajedavcev pri konjih.
English: Parascaris equorum should have been selected as the dose limiting parasite.
Slovenian: Vrsto Parascaris equorum bi morali izbrati kot zajedavca, ki omejujejo odmerek.
English: - The mean dose of test product administered was consistently and significantly more (40%, 0.278mg/kg) than the recommended treatment dose.
Slovenian: - Povprečen odmerek testnega izdelka je bil stalno in značilno večji (40 %, 0,278 mg/kg) od priporočenega odmerka za zdravljenje.