natgillin/translations-raw huggingface dataset:
0.563 (0.461, 0.687), p<0.000001
0,576 (0,463; 0,718), p < 0,000001 0,563 (0,461; 0,687), p < 0,000001
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.
Pri podganah so pri odmerku ≥ 100 mg/kg/dan opazili povečano incidenco skeletnih sprememb (povečana incidenca prisotnosti rebra na sedmem vratnem vretencu).
Placebo plus letrozole (N=110)
Placebo in letrozol (n = 110)
0.653 (0.505, 0.844), p=0.000532
0,653 (0,505; 0,844), p = 0,000532 0,611 (0,485; 0,769), p = 0,000012
You should not breast-feed while taking IBRANCE.
Med zdravljenjem z zdravilom IBRANCE ne smete dojiti.
Placebo plus letrozole (N=112)
Placebo in letrozol (n = 112)
IBRANCE 75 mg hard capsules IBRANCE 100 mg hard capsules IBRANCE 125 mg hard capsules palbociclib
IBRANCE 75 mg trde kapsule IBRANCE 100 mg trde kapsule IBRANCE 125 mg trde kapsule palbociklib
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.
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.
Each hard capsule contains 56 mg of lactose (as monohydrate).
Pomožna snov z znanim učinkom: Ena trda kapsula vsebuje 56 mg laktoze (v obliki monohidrata).
No dose adjustment of IBRANCE is required for patients with mild or moderate hepatic impairment (Child-Pugh classes A and B).
Pri bolnikih z blago ali zmerno okvaro jeter (razreda A in B po klasifikaciji Child-Pugh) prilagajanje odmerka zdravila IBRANCE ni potrebno.
Dry eye
suha koža
Each hard capsule contains 74 mg of lactose (as monohydrate).
Pomožna snov z znanim učinkom: Ena trda kapsula vsebuje 74 mg laktoze (v obliki monohidrata).
EU/1/16/1147/005 (21 hard capsules) EU/1/16/1147/009 (63 hard capsules)
EU/1/16/1147/005 (21 trdih kapsul) EU/1/16/1147/009 (63 trdih kapsul)
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.
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.
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.
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.
100 mg/day
100 mg/dan drugo zmanjšanje odmerka
Tell your doctor, pharmacist or nurse if you experience signs or symptoms of an infection, such as chills or fever.
Če opazite znake ali simptome okužbe, kot sta mrzlica ali vročina, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
EU/1/16/1147/003 (21 hard capsules) EU/1/16/1147/008 (63 hard capsules)
EU/1/16/1147/003 (21 trdih kapsul) EU/1/16/1147/008 (63 trdih kapsul)
IBRANCE 125 mg hard capsules
IBRANCE 125 mg trde kapsule
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.
C] palbocikliba ljudem so glavne primarne presnovne poti za palbociklib vključevale oksidacijo in sulfonacijo, acilacija in glukoronidacija pa sta prispevali kot manj pomembni poti.
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.
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.
There were no effects on oestrous cycle (female rats) or mating and fertility in rats (male or female) in nonclinical reproductive studies.
Predklinične študije sposobnosti razmnoževanja na podganah niso pokazale nobenih učinkov na cikel estrusa (pri samicah podgan) ali parjenje in plodnost (pri samcih ali samicah).
Ibrance plus Letrozole or Fulvestrant
Zdravilo IBRANCE in letrozol ali fulvestrant
IBRANCE plus letrozole (N=230)
Zdravilo IBRANCE in letrozol (n = 230)
- IBRANCE 75 mg hard capsule: each capsule contains 75 mg palbociclib.
IBRANCE 75 mg trde kapsule: ena kapsula vsebuje 75 mg palbocikliba.
Palbociclib is considered to have the potential to impair reproductive function and fertility in male humans based on nonclinical findings in rats and dogs.
Na podlagi predkliničnih ugotovitev pri podganah in psih velja, da palbociklib potencialno lahko okvari sposobnost razmnoževanja in plodnost pri moških.
Progression-free survival (PFS) Number of events (%) Median [months (95% CI)] Hazard ratio (95% CI) and p-value
Preživetje brez napredovanja bolezni (PFS) število dogodkov (%) mediana [meseci (95 % IZ)] razmerje ogroženosti (95 % IZ) in vrednost p
Permanently discontinue IBRANCE in patients with severe ILD or pneumonitis (see section 4.2).
Pri bolnikih s hudo ILD ali pnevmonitisom je treba zdravljenje z zdravilom IBRANCE trajno prekiniti (glejte poglavje 4.2).
- IBRANCE 100 mg hard capsule: each capsule contains 100 mg palbociclib.
IBRANCE 100 mg trde kapsule: ena kapsula vsebuje 100 mg palbocikliba.
- IBRANCE 125 mg hard capsule: each capsule contains 125 mg palbociclib.
IBRANCE 125 mg trde kapsule: ena kapsula vsebuje 125 mg palbocikliba.
Drug-drug interaction between palbociclib and letrozole
Medsebojna delovanja med palbociklibom in letrozolom
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.
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.
IBRANCE 100 mg hard capsules Each hard capsule contains 100 mg of palbociclib.
IBRANCE 100 mg trde kapsule Ena trda kapsula vsebuje 100 mg palbocikliba.
Talk to your doctor, pharmacist or nurse before taking IBRANCE.
Pred začetkom jemanja zdravila IBRANCE se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
IBRANCE 125 mg hard capsules Each hard capsule contains 125 mg of palbociclib.
IBRANCE 125 mg trde kapsule Ena trda kapsula vsebuje 125 mg palbocikliba.
IBRANCE 75 mg hard capsules Each hard capsule contains 75 mg of palbociclib.
IBRANCE 75 mg trde kapsule Ena trda kapsula vsebuje 75 mg palbocikliba.
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.
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 %.
- 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).
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”).
Opaque, hard capsule, with a light orange body (printed “PBC 75” in white) and a light orange cap (printed “Pfizer” in white).
Neprozorna, trda kapsula s svetlo oranžnim telesom (z belo natisnjeno oznako “PBC 75”) in svetlo oranžnim pokrovčkom (z belo natisnjeno oznako “Pfizer”).
IBRANCE plus letrozole (N=214)
Zdravilo IBRANCE in letrozol (n = 214)
Hazard ratio [(95% CI) and p-value]
razmerje ogroženosti [(95 % IZ) in vrednost p]
No dose adjustments are required for coadministration of palbociclib with moderate CYP3A inducers (see section 4.5).
Pri sočasni uporabi palbocikliba z zmernimi induktorji CYP3A prilagajanje odmerka ni potrebno (glejte poglavje 4.5).
f Thrombocytopenia includes the following PTs: Thrombocytopenia, Platelet count decreased.
f. Trombocitopenija vključuje naslednje PT: trombocitopenija, zmanjšanje števila trombocitov.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL - 100 MG CAPSULES
NALEPKA NA PLASTENKI - 100 MG KAPSULE
- 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).
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”).
How to store IBRANCE
Shranjevanje zdravila IBRANCE
Opaque, hard capsule, with a caramel body (printed “PBC 125” in white) and a caramel cap (printed “Pfizer” in white).
Neprozorna, trda kapsula s karamelnim telesom (z belo natisnjeno oznako “PBC 125”) in karamelnim pokrovčkom (z belo natisnjeno oznako “Pfizer”).
OR [%, (95% CI)] TTR, Median [months (range)]
TTR, mediana [meseci (razpon)]
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.
Zdravilo IBRANCE vzemite enkrat na dan, vsak dan ob približno istem času, skupaj s hrano, priporočljivo z obrokom.
Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia.
Pri bolnikih, pri katerih se razvije nevtropenija stopnje 3 ali 4, je priporočljiva prekinitev odmerjanja,
NAME OF THE MEDICINAL PRODUCT IBRANCE 100 mg hard capsules palbociclib
IBRANCE 100 mg trde kapsule palbociklib
Discuss contraception with your doctor if there is any possibility that you or your partner may become pregnant.
Če obstaja možnost, da lahko zanosite ali lahko zanosi vaša partnerka, se posvetujte z zdravnikom glede kontracepcije.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 125 MG CAPSULES
NALEPKA NA PLASTENKI - 125 MG KAPSULE
Opaque, hard capsule, with a light orange body (printed “PBC 100” in white) and a caramel cap (printed “Pfizer” in white).
Neprozorna, trda kapsula s svetlo oranžnim telesom (z belo natisnjeno oznako “PBC 100”) in karamelnim pokrovčkom (z belo natisnjeno oznako “Pfizer”).
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL - 75 MG CAPSULES
NALEPKA NA PLASTENKI - 75 MG KAPSULE
NAME OF THE MEDICINAL PRODUCT IBRANCE 125 mg hard capsules palbociclib
IBRANCE 125 mg trde kapsule palbociklib
Appropriate monitoring should be performed (see sections 4.2 and 4.8).
zmanjšanje odmerka ali odložitev začetka ciklov zdravljenja, bolnike pa je treba ustrezno spremljati (glejte poglavji 4.2 in 4.8).
Palbociclib did not prolong the QTc to any clinically relevant extent at the recommended dose of 125 mg daily (Schedule 3/1).
Ob priporočenem odmerku 125 mg na dan (shema 3/1) palbociklib ni podaljšal intervala QTc v klinično pomembnem obsegu.
The majority of the material was excreted as metabolites.
Učinkovina se je večinoma izločila v obliki presnovkov.
In particular, the following may increase the risk of side effects with IBRANCE:
Tveganje za pojav neželenih učinkov zdravila IBRANCE lahko še zlasti povečajo naslednja zdravila:
NAME OF THE MEDICINAL PRODUCT IBRANCE 75 mg hard capsules palbociclib
IBRANCE 75 mg trde kapsule palbociklib
- use of preparations containing St. John's Wort should be avoided while you are taking IBRANCE.
-v času jemanja zdravila IBRANCE ne jemljite pripravkov, ki vsebujejo šentjanževko.
Dry skin General disorders and administration site conditions
Bolezni kože in podkožja zelo pogosti izpuščaj alopecija
• chest pain
• bolečina v prsnem košu.
You should avoid becoming pregnant while taking IBRANCE.
Med jemanjem zdravila IBRANCE se izogibajte zanositvi.
Palbociclib is a weak, time-dependent inhibitor of CYP3A following daily 125 mg dosing at steady state.
Po dnevnem odmerjanju 125 mg je palbociklib v stanju dinamičnega ravnovesja šibek, časovnoodvisen zaviralec CYP3A.
* Adverse Drug Reaction (ADR) identified post-marketing.
Neželeni učinek, ugotovljen v obdobju trženja zdravila.
Patients were well matched for baseline demographics and prognostic characteristics between the palbociclib plus letrozole arm and the placebo plus letrozole arm.
Bolnice skupine s palbociklibom in letrozolom in skupine s placebom in letrozolom so bile precej enakovredne glede izhodiščnih demografskih podatkov in prognostičnih značilnosti.
EU/1/16/1147/007 (63 hard capsules)
EU/1/16/1147/001 (21 trdih kapsul) EU/1/16/1147/007 (63 trdih kapsul)
Patients were well matched for baseline demographics and prognostic characteristics between the palbociclib plus fulvestrant arm and the placebo plus fulvestrant arm.
Bolnice skupine s palbociklibom in fulvestrantom in skupine s placebom in fulvestrantom so bile precej enakovredne glede izhodiščnih demografskih podatkov in prognostičnih značilnosti.
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 125 mg palbociclib.
Ena kapsula vsebuje 125 mg palbocikliba.
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 100 mg palbociclib.
Ena kapsula vsebuje 100 mg palbocikliba.
Decreased appetite Nervous system disorders
Bolezni prebavil zelo pogosti stomatitis navzea diareja bruhanje
Netherlands, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Norway, Poland, Portugal and Spain.
Nizozemska, Avstrija, Belgija, Danska, Finska, Francija, Nemčija, Grčija, Madžarska, Irska, Italija, Luksemburg, Norveška, Poljska, Portugalska in Španija.
The indication proposed cannot be accepted.
Predlagane indikacije ni mogoče sprejeti.
The youngest horse included in the field trial was 16 months old.
Najmlajši konj, ki je bil vključen v terensko raziskavo, je bil star 16 mesecev.
Product invented name
Izmišljeno ime izdelka
The test procedure did not follow the methods for a controlled or critical test.
Postopek testiranja ni upošteval metod za kontrolirano ali kritično raziskavo.
Retreatment should be done according to the epidemiological situation, but not at less than 30 days interval
Ponovno zdravljenje se naj izvaja v skladu z epidemiološko situacijo, vendar ne v intervalu, ki je krajši od 30 dni.
Efficacy should have been investigated at the lowest dose recommended.
Učinkovitost bi morala biti preučena pri najmanjšem priporočenem odmerku.
Thus the proposal from the MAH, although scientifically justified, remains practically very questionable.
Zato ostaja predlog imetnika dovoljenja za promet, čeprav je znanstveno utemeljen, v praksi dejansko zelo vprašljiv.
The wording of the proposal for Section 4.2 of the SPC is not supported.
Predlagano besedilo poglavja 4.2 SPC ni utemeljeno.
Frequency and route of administration
Pogostost in način uporabe
Based on the critical test performed, the efficacy against Parascaris was 100%.
Na podlagi opravljene kritične raziskave je bila učinkovitost proti rodu Parascaris 100 %.
The WAAVP guidelines state that, for a field trial, data from at least 100 horses should be obtained in each of 3 different areas.
Smernice združenja WAAVP navajajo, da je treba pri terenskih raziskavah zbrati podatke za najmanj 100 konj za vsako od 3 različnih področij.
A single field study was submitted in support of the efficacy of the product.
Predložena je bila ena terenska raziskava, ki je utemeljevala učinkovitost izdelka.
The relative egg reductions calculations do not reflect these findings, particularly regarding P. equorum.
Izračuni relativnega zmanjšanja števila jajčec ne odražajo teh izsledkov, še zlasti ne pri vrsti P. equorum.
The results for efficacy of Eqvalan measured this way were also below 90%.
Tudi rezultati učinkovitosti zdravila Eqvalan, ki so bili izmerjeni na ta način, so bili pod 90 %.
ANNEX III CONDITION FOR THE LIFTING OF THE SUSPENSION
DODATEK III POGOJ ZA PREKLIC UMIKA
Recommended dose
Priporočen odmerek
- This was not a multicentric trial.
- Nobena raziskava ni bila multicentrična.
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.
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.
Parascaris equorum should have been selected as the dose limiting parasite.
Vrsto Parascaris equorum bi morali izbrati kot zajedavca, ki omejujejo odmerek.
- The mean dose of test product administered was consistently and significantly more (40%, 0.278mg/kg) than the recommended treatment dose.
- Povprečen odmerek testnega izdelka je bil stalno in značilno večji (40 %, 0,278 mg/kg) od priporočenega odmerka za zdravljenje.
Therefore the relevance of the bibliographical data regarding Eqvalan to the test product cannot be confirmed.
Zato ustreznosti bibliografskih podatkov o zdravilu Eqvalan za testni izdelek ni mogoče potrditi.
It is known that there is a potential resistance build up to ivermectin in Parascaris equorum, however the highest number of P. equorum may be found in grazing horses 3-18 months old.
Znano je, da obstaja možnost razvoja odpornosti pri vrsti Parascaris equorum na ivermektin, vendar pa je največje število P. equorum mogoče najti pri konjih, starih med 3 in 18 meseci, ki se pasejo.
If it is assumed that the tables submitted in the response dossier refer to the results from the field study submitted in the original dossier, then these data are inadequate and therefore irrelevant due to the following reasons:
Če predpostavimo, da se tabele, ki so bile predložene v dokumentaciji odgovora, nanašajo na rezultate terenske raziskave, ki so bili predloženi v izvirni dokumentaciji, so ti podatki neustrezni in jih posledično ni mogoče upoštevati iz naslednjih razlogov:
For Parascaris type eggs, the results were 50% by day 3 and 65.2% by day 8.
Za jajčeca rodu Parascaris je bilo 3. dne zmanjšanje 50 %, 8. dan pa 65,2 %.
ANNEX I NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER
DODATEK I IME, FARMACEVTSKA OBLIKA, JAKOST ZDRAVILA, ŽIVALSKE VRSTE, NAČINI UPORABE IN IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
CONDITION FOR THE LIFTING OF THE SUSPENSION
POGOJ ZA PREKLICA UMIKA
For dose confirmation studies, ‘at least two controlled or, where appropriate, critical dose confirmation studies ….. are recommended.'
Za raziskave za določitev odmerka velja, da »sta priporočljivi vsaj dve kontrolirani ali, kjer ustreza, kritični raziskavi za določitev odmerka«.
The number of horses with an adequate infection pretreatment is impossible to determine as no negative control group was included.
Nemogoče je določiti število konjev z ustreznim predhodnim zdravljenjem okužb, saj raziskava ni vsebovala negativne kontrolne skupine.
- Although non-inferiority was demonstrated to Eqvalan, this is not a recognised measure of efficacy of a new product.
- Čeprav je bila dokazana enakovrednost zdravilu Eqvalan, to ni priznano merilo učinkovitosti novega izdelka.
Therefore, this product would not be considered interchangable with other ivermectin containing products already on the market.
Posledično tega izdelka ne bi bilo mogoče obravnavati kot medsebojno zamenljivega z drugimi izdelki, ki vsebujejo ivermektin in so že na trgu.
The current application cannot be considered satisfactory as there is no scientific basis on which to grant an authorisation with the proposed SPC.
Sedanje vloge ni mogoče oceniti kot zadovoljive, saj ni znanstvene osnove, na podlagi katere bi bilo mogoče odobriti dovoljenje s predlaganim Povzetkom glavnih značilnosti zdravila (SPC).
The bioequivalence with the originator product should be demonstrated by appropriate bioavailability study or adequate data should be provided with regard to residues and efficacy for this kind of application and the results of such study or such data should be submitted to the relevant national authority for further assessment.
Bioekvivalenco z originatorskim izdelkom mora potrditi ustrezna raziskava biološke uporabnosti oziroma predložiti je treba ustrezne podatke o ostankih in učinkovitosti za tovrstno uporabo, rezultate takšne raziskave ali takšne podatke pa je treba predložiti ustreznemu državnemu organu v nadaljnjo presojo.
The Marketing Authorisation Holder reexamined the data from this study and stated that on day 6 after treatment no small nor large strongyle larvae were detected in a minimum amount of 25 gram faeces indicating 100% efficacy for all animals, and the recalculated effectiveness against Strongylides is >> 90% on 2 and 7 days after treatment.
Imetnik dovoljenja za promet je znova preučil podatke iz te raziskave in izjavil, da 6. dan po zdravljenju v minimalni količini blata 25 gramov ni bilo več ličink ne malih ne velikih strongilidov, kar kaže na 100 % učinkovitost za vse živali, preračunana učinkovitost proti strongilidom za 2. in 7. dan po zdravljenju pa je >> 90 %.
Based on the following, interchangeability with other ivermectin containing products cannot be accepted:
Na podlagi naslednjega ni mogoče sprejeti medsebojne zamenljivosti z drugimi izdelki, ki vsebujejo ivermektin:
The statement ‘The treatment of gastrointestinal endoparasite infections in horses' implies that all gastrointestinal endoparasite infections in horses are treated with this product; ‘particularly' implies that the product has a specific action against those species listed.
Iz navedbe „Zdravljenje gastrointestinalnih endoparazitskih okužb pri konjih“ sledi, da se s tem zdravilom zdravijo vse gastrointestinalne endoparazitske okužbe pri konjih; „še zlasti“ izraža, da ima izdelek poseben učinek proti navedenim vrstam.
Even the amended indication for the treatment of gastrointestinal endoparasitic infections in horses has not been demonstrated by the data provided.
Tudi spremenjene indikacije za zdravljenje gastrointestinalnih endoparazitskih okužb pri konjih predloženi podatki ne dokazujejo.
Without necropsy or a large sample size, it is impossible to draw any meaningful conclusions from this study regarding the efficacy of Equimectin.
Brez nekropsije ali velikega vzorca ni mogoče priti do merodajnih zaključkov iz te raziskave glede učinkovitosti zdravila Equimectin.
- The dose-limiting parasite had not been specified or selected.
- Zajedavci, ki omejujejo uporabo odmerka, niso bili določeni ali izbrani.
Relative reductions for the number of eggs per gram of faeces for the test product were calculated as 88.2% against Strongylus type eggs on day 3, and 88.2% at day 8.
Relativno zmanjšanje števila jajčec rodu Strongylus v gramu iztrebkov za testni izdelek je bilo 3. dan 88,2 % in 8. dan 88,2 %.
This does not comply with the recommendations of the current guidance document (CVMP/VICH/832/99), ‘where pharmacokinetic parameters cannot demonstrate a relationship with effectiveness, two dose confirmation studies using the dose limiting parasite for therapeutic claims ….. will be needed.'
To ni v skladu s priporočili veljavne smernice (CVMP/VICH/832/99), po kateri sta »v primeru, da farmakokinetični parametri ne morejo dokazati povezave z učinkovitostjo, za uveljavljani terapevtski učinek potrebni dve raziskavi za določitev odmerka na zajedavcih, ki omejujejo odmerek«.
A single administration of 0.2 mg ivermectin per kg of bodyweight.
En odmerek 0,2 mg ivermektina na kg telesne mase.