natgillin/translations-raw huggingface dataset:
The most frequent side effects with Zoely (seen in more than 1 user in 10) are acne and changes to menstrual periods (e.g. absence or irregularity).
Najpogostejši neželeni učinki zdravila Zoely (opaženi pri več kot 1 uporabnici od 10) so akne in spremembe menstruacije (npr. odsotnost ali nerednost).
In women aged 18 to 35, the Pearl Index was around 0.4 with Zoely and 0.8 with the comparator medicine in the first study, and around 1.2 with Zoely and 1.9 with the comparator medicine in the second study.
Pri ženskah v starosti od 18 do 35 let je znašal Pearlov indeks v prvi študiji približno 0,4 z zdravilom Zoely in 0,8 s primerjalnim zdravilom, v drugi študiji pa približno 1,2 z zdravilom Zoely in 1,9 s primerjalnim zdravilom.
This is a summary of the European public assessment report (EPAR) for Zoely.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zoely.
What benefit has Zoely shown during the studies?
Kakšne koristi je zdravilo Zoely izkazalo med študijami?
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zoely, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
For more information about treatment with Zoely, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Zoely preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
It should not be used in women who have pancreatitis (inflammation of the pancreas), severe liver problems, liver tumours or a history of liver tumours, certain types of cancer, or abnormal bleeding from the genital area whose cause has not been diagnosed.
Ne sme se uporabljati pri ženskah s pankreatitisom (vnetjem trebušne slinavke), hudim obolenjem jeter, tumorji na jetrih ali anamnezo tumorjev na jetrih, določenimi vrstami raka ali nenormalnimi krvavitvami v genitalnem predelu, katerih vzrok še ni bil ugotovljen.
A risk management plan has been developed to ensure that Zoely is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Zoely je bil pripravljen načrt obvladovanja tveganj.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zoely.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Estradiol is the same as a hormone naturally produced by the ovaries during a menstrual cycle.
Estradiol je popolnoma enak hormonu, ki naravno nastaja v jajčnikih med menstrualnim ciklom.
Zoely must not be used when a woman has, or has had, blood clots in the veins or arteries or when a woman has some of the risk factors for blood clots.
Zdravilo Zoely se ne sme uporabljati pri ženskah, ki imajo ali so imele krvne strdke v venah ali arterijah ali ki imajo nekatere od dejavnikov tveganja za nastanek krvnih strdkov.
The CHMP decided that the benefits of Zoely are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
What is the risk associated with Zoely?
Kakšna tveganja so povezana z zdravilom Zoely?
Zoely comes in blisters containing 28 tablets (24 white tablets followed by 4 yellow tablets), which are taken in sequence using stickers to identify the days of the week for each tablet.
Zdravilo Zoely je na voljo v pretisnem omotu, ki vsebuje 28 tablet (24 belih tablet, ki jim sledijo 4 rumene tablete), ki se jemljejo zaporedno, za označevanje dneva v tednu pa se za vsako tableto uporabi nalepka z dnevno oznako.
Zoely is a medicine available as 24 white ‘active' tablets that contain the active substances nomegestrol acetate (2.5 mg) and estradiol (1.5 mg), and four yellow ‘inactive' (placebo) tablets that do not contain any active substance.
Zdravilo Zoely je na voljo v obliki 24 belih „aktivnih“ tablet, ki vsebujejo zdravilni učinkovini nomegestrolacetat (2,5 mg) in estradiol (1,5 mg), in štirih rumenih „neaktivnih“ (placebo) tablet, ki ne vsebujejo zdravilnih učinkovin.
Zoely works by changing the body's hormonal balance to prevent ovulation, by altering the cervical mucus and by thinning the endometrium (the lining of the womb).
Zdravilo Zoely deluje tako, da spremeni hormonsko ravnovesje telesa in s spremembo sluzi materničnega vratu in tanjšanjem endometrija (maternične sluznice) prepreči ovulacijo.
Nomegestrol acetate is derived from the hormone called progesterone which is also produced by the ovaries during a menstrual cycle.
Nomegestrolacetat nastane iz hormona, imenovanega progesteron, ki prav tako nastaja v jajčnikih med menstrualnim ciklom.
For the full list of all side effects reported with Zoely, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Zoely, glejte navodilo za uporabo.
Zoely is a combined contraceptive pill that contains two active substances, nomegestrol acetate (a progestogen) and estradiol (an oestrogen).
Zdravilo Zoely je kombinirana kontracepcijska tableta, ki vsebuje dve zdravilni učinkovini, nomegestrolacetat (progesteron) in estradiol (estrogen).
Why has Zoely been approved?
Zakaj je bilo zdravilo Zoely odobreno?
The participants were given either Zoely or another contraceptive pill containing drospirenone and ethinyl estradiol for one year (13 menstrual cycles).
Udeleženke študije so eno leto (13 menstrualnih ciklusov) prejemale bodisi zdravilo Zoely bodisi drugo kontracepcijsko tableto, ki je vsebovala drospirenon in etinilestradiol.
What is Zoely?
Kaj je zdravilo Zoely?
How has Zoely been studied?
Kako je bilo zdravilo Zoely raziskano?
How does Zoely work?
Kako zdravilo Zoely deluje?
How is Zoely used?
Kako se zdravilo Zoely uporablja?
What is Zoely used for?
Za kaj se zdravilo Zoely uporablja?
No guideline was given.
Smernice niso bile podane.
It may be considered appropriate that such additional measures are applied in the future in the light of any new information.
Morda bo primerno tovrstne dodatne ukrepe v luči novih informacij izvajati v prihodnje.
Low High
Nizka Visoka
The field study should fulfil the following criteria:
Terenska študija mora izpolnjevati naslednja merila:
NOEC: the concentration in the study at which no effects are observed.
NOEC: koncentracija v študiji, pri kateri ni opaženih nobenih učinkov.
However, the data provided for Tier B and C assessment do not comply with current standards.
Vendar podatki iz ocenjevanja stopnje B in C ne ustrezajo trenutnim standardom.
• Concentrations of moxidectin in the different target matrices.
• Koncentracije moksidektina v različnih ciljnih matricah.
The following findings should be reported:
Poročati je treba o naslednjih izsledkih:
Direct therapeutic benefits
Neposredne terapevtske koristi
Nevertheless, the results of this study supported the conclusion on persistence from the first study.
Kljub temu rezultati te študije podpirajo zaključek o obstojnosti iz prve študije.
In case of insufficient space on the label:
Če na nalepki ni dovolj prostora:
• The duration of the study should be three consecutive years in order to consider seasonal and annual variations.
• Trajanje študije naj bo tri leta zaporedoma, da se pri tem upoštevajo sezonska in letna nihanja.
P. promelas (early life stages)
P. promelas (zgodnje razvojne stopnje)
Quality, target animal safety, user safety, consumer safety and efficacy were not assessed in this referral procedure.
Kakovost, varnost ciljnih živalskih vrst, varnost uporabnikov in učinkovitost se v tem napotitvenem postopku niso ocenjevali.
• The study should be performed in one or more European geographical regions, representing worst case climatic and epidemiological conditions and adjacent to small water bodies.
• Študijo je treba izvesti v eni ali več evropskih geografskih regijah, ki predstavljajo najslabše klimatske in epidemiološke pogoje, v bližini majhnih vodnih teles.
The following conditions should be fulfilled by all marketing authorisation holders: Conditions
Vsi imetniki dovoljenj za promet z zdravilom morajo izpolnjevati naslednje pogoje: Pogoji
However, toxicity to sediment-dwelling organisms is still very likely.
Vendar pa je strupenost za organizme, ki živijo v sedimentu, še vedno zelo verjetna.
Not determined
Ni določeno
The aforementioned internal and external parasites are recognised as causing significant loss of production and negatively impacting on animal welfare.
Priznava se, da prej omenjeni notranji in zunanji paraziti povzročajo velike izgube pri prireji in negativno vplivajo na dobro počutje živali.
However, it has to be noted that the use of QSAR values as a substitute for experimental data for pharmaceuticals is not supported as no validated models are available for pharmaceuticals.
Treba pa je poudariti, da uporaba vrednosti QSAR kot nadomestka eksperimentalnih podatkov za zdravila ni podprta, saj za zdravila ni na voljo validiranih modelov.
Do not contaminate watercourses with the product.
Z zdravilom ne onesnažite vodotokov.
Other precautions regarding impact on the environment
Drugi previdnostni ukrepi v zvezi z vplivom na okolje
The conditions imposed on the marketing authorisations are described in Annex IV.
Pogoji, ki veljajo za dovoljenja za promet z zdravilom, so navedeni v Prilogi IV.
Add, to all products:
Vsem zdravilom dodajte:
A risk to the environment has been identified which can be partially mitigated by appropriate risk mitigation measures.
Ugotovljeno je bilo tveganje za okolje, ki ga je mogoče delno ublažiti s primernimi ukrepi za zmanjšanje tveganja.
Mineralisation (evolution of 14CO2) accounted for up to 5% of the applied radioactivity.
Mineralizacija (nastajanje 14CO2) je zajemala do 5 % dodane radioaktivnosti.
Daphnia magna (reproduction)
Daphnia magna (razmnoževanje)
Risk to the environment
Tveganje za okolje
The final study report should be submitted to the CVMP for assessment.
Končno poročilo o študiji se predloži odboru CVMP v oceno.
To mitigate this risk, all precautions for use and disposal must be adhered to.
Za zmanjšanje tega tveganja je treba upoštevati vse previdnostne ukrepe za uporabo in odstranjevanje.
The CVMP considered that such warning is not in line with good agricultural practice and therefore should be deleted from the product information.
Odbor CVMP je presodil, da tako opozorilo ni v skladu z dobro kmetijsko prakso, zato ga je treba izbrisati iz informacij o zdravilu.
If the study is conducted in one geographical region, the marketing authorisation holders should justify that this is truly the worst case.
Če se študija izvaja samo v eni geografski regiji, morajo imetniki dovoljenj za promet z zdravilom utemeljiti, da je tam res najslabši možni primer.
A terrestrial plant study with 12 weed species was also provided which was considered not relevant for the current assessment.
Predložena je bila tudi študija s kopenskimi rastlinami z 12 vrstami plevela, ki za trenutno oceno ni bila relevantna.
It can be concluded that there is a negligible risk for secondary poisoning from moxidectin.
Zaključiti je mogoče, da obstaja zanemarljivo tveganje za sekundarno zastrupitev zaradi moksidektina.
Within 12 months of Commission Decision for this procedure
V 12 mesecih po odločbi Komisije glede tega postopka
Environmental profile of alternatives
Okoljski profil drugih možnosti
6100 (horse, oral)
6 100 (konji, peroralno)
The subsequent evaluation of data generated further to the fulfilment of these conditions should be undertaken by the CVMP due to the complexity of the data thus generated and in the interest of maintaining the harmonised EU approach achieved by this referral procedure.
Odbor CVMP mora nadalje ovrednotiti podatke, pridobljene v zvezi z izpolnjevanjem teh pogojev, in sicer zaradi kompleksnosti tako pridobljenih podatkov in v interesu ohranitve usklajenega pristopa EU, doseženega s tem napotitvenim postopkom.
The abovementioned data should be provided to the CVMP for assessment not later than 5 years after the Commission Decision on this referral procedure.
Zgornje podatke je treba predložiti odboru CVMP v oceno najpozneje v 5 letih po odločbi Komisije glede tega postopka.
Levels of radioactivity recovered in the organic soil extracts at the end of the study at day 63 ranged between 74-82%.
Ravni radioaktivnosti v organskih talnih ekstraktih ob koncu študije na 63. dan so bile med 74 in 82 %.
The Committee was also asked to recommend whether the marketing authorisations for the aforementioned veterinary medicinal products should be maintained, varied, suspended or withdrawn.
Odbor je zaprosila tudi, naj priporoči, ali naj se dovoljenja za promet z zgoraj navedenimi zdravili za uporabo v veterinarski medicini ohranijo, spremenijo, začasno umaknejo ali odvzamejo.
Within 60 months of Commission Decision for this procedure
V 60 mesecih po odločbi Komisije glede tega postopka
As exposure of aquatic organism is unlikely to occur, the toxicity will be reduced significantly.
Ker je izpostavljenost vodnih organizmov malo verjetna, se strupenost bistveno zmanjša.
On the other hand, there is evidence from literature (Prichard et al., 2012)18 that the resistance against avermectins and moxidectin is not always genetically identical, which implies that avermectin resistant parasite strains can be successfully treated with moxidectin.
Po drugi strani v literaturi obstajajo dokazi (Prichard idr., 2012),18 da odpornost proti avermektinom in moksidektinu ni vedno genetsko enaka, kar pomeni, da seve parazitov, ki so odporni proti avermektinom, lahko uspešno zdravimo z moksidektinom.
Detailed information on the field study design (protocol), including proposals for timelines for the provision of interim reports, should be submitted to the CVMP.
Odboru CVMP je treba predložiti podrobne informacije o zasnovi terenske študije (protokolu), vključno s predlogi za časovnice za predložitev vmesnih poročil.
Residues in dung were toxic to dung flies for more than 7 days or for more than 28 days after treatment, depending on study duration, species and formulation.
Ostanki v gnoju so bili za jesensko muho strupeni več kot 7 dni ali več kot 28 dni po zdravljenju, odvisno od trajanja študije, vrste in formulacije.
PBT substances pose a hazard where the fate and behaviour in the environment and its toxicity in the long-term cannot be predicted.
Snovi PBT so nevarne, kadar njihovega končnega stanja in obnašanja v okolju ter njihove dolgoročne strupenosti ni mogoče napovedati.
When considering persistence under field conditions, the Committee acknowledged that degradation mechanisms exist and that a soil temperature of 12 °C might not be representative for all European regions.
Pri ocenjevanju obstojnosti v terenskih pogojih je odbor priznal, da obstajajo mehanizmi razgradnje in da temperatura tal 12 °C morda ni reprezentativna za vse evropske regije.
So far, no criteria for bioaccumulation assessment in sediment or soil organisms have been established and the classification is based on the standard bioaccumulation study in fish.
Do zdaj še ni uveljavljenih meril za ocenjevanje kopičenja v organizmih sedimenta ali tal, razvrstitev pa temelji na standardnih študijah kopičenja v ribah.
This implies that when allowing moxidectin to enter water bodies, this may have a severe and lasting impact on aquatic life.
To pomeni, da vnos moksidektina v vodna telesa lahko povzroči resne in dolgotrajne učinke na vodno življenje.
It was concluded that moxidectin degrades in soil with a dissipation half-life (DT50) of approximately 2 months and slowly mineralises.
Zaključili so, da moksidektin v tleh razpada z razpolovno dobo razkroja (DT50) približno 2 meseca in se počasi mineralizira.
Both studies were performed with Chironomus riparius exposed via spiked sediment.
Obe študiji so opravili na organizmu Chironomus riparius, izpostavljenem prek sedimenta z dodano učinkovino.
Material balance, calculated as the percent of applied radioactivity, was maintained within guideline specification (90-110% of applied radioactivity) for all four soils.
Materialno ravnovesje, izračunano kot odstotek dodane radioaktivnosti, so pri vseh štirih vrstah tal vzdrževali znotraj specifikacij v smernici (90-110 % dodane radioaktivnosti).
The bioconcentration factor was also calculated as the ratio between uptake rate constant (k1) and depuration rate constant (k2).
Biokoncentracijski faktor so izračunali tudi kot razmerje med konstanto stopnje absorpcije (k1) in konstanto stopnje očiščenja (k2).
Moxidectin, Clostridium septicum, Clostridium perfringens D, Clostridium tetani,
moksidektin, Clostridium septicum, Clostridium perfringens D, Clostridium tetani,
That is, the marketing authorisation holders argued that mean land surface temperatures during spring/summer in predominant agricultural regions in Europe are likely to be higher leading to a faster degradation.
Imetniki dovoljenj za promet z zdravilom so torej trdili, da so povprečne temperature površin zemljišč spomladi/poleti v glavnih kmetijskih regijah v Evropi verjetno višje, kar pomeni hitrejšo razgradnjo.
Consequently, risk mitigation measures tempering a quantitative risk are considered suitable neither to eliminate the hazard nor to prevent emission into the environment.
Zato ukrepi za zmanjšanje tveganja, ki omilijo kvantitativno tveganje, niso primerni ne za odpravo nevarnosti ne za preprečevanje emisij v okolju.
Nevertheless, in case of repeated treatments with moxidectin (as with products of the same anthelmintic class) it is advisable not to treat animals every time on the same pasture to allow dung fauna populations to recover.
Kljub temu je v primeru ponavljajočega se zdravljenja z moksidektinom (kot velja tudi za druga zdravila iz istega razreda antihelmintikov) priporočljivo, da se ne zdravijo vsakič živali na istem pašniku, s čimer omogočimo okrevanje populacij organizmov v gnoju.
Zoetis Portugal, Lda.
Portugalska Zoetis Portugal, Lda.
• Evidence of a trend i.e. increasing/decreasing concentrations or plateau.
• Dokaz za trend, tj. naraščajoče/padajoče koncentracije, ali konstantno vrednost.
The bioconcentration factors were also determined as a function of lipid content of the fish following normalisation for a lipid content of 5%.
Biokoncentracijske faktorje so določali tudi kot funkcijo vsebnosti maščob v ribah po normalizaciji na 5-odstotno vsebnost maščob.
As the mean recovery of moxidectin at the end of the study (63 days) was less than 50%, a value of 63 days is used as half-life value of moxidectin.
Ker je bil povprečen izplen moksidektina na koncu študije (63 dni) manj kot 50 %, se kot razpolovna vrednost moksidektina uporablja vrednost 63 dni.
Emission and risk assessment
Ocena emisij in tveganja
Non-extractable residues accounted for 4-10% of the radioactivity applied to the soil.
Neizločljivi ostanki so obsegali 4-10 % radioaktivnosti, dodane v tla.
Based on the [3H]-residues as [3H]-moxidectin in the test media, the bioconcentration factors for whole fish tissue were as follows:
Na osnovi [3H]-ostankov v obliki [3H]-moksidektina v testnem mediju so bili biokoncentracijski faktorji za celotno tkivo ribe naslednji:
It was argued that laboratory conditions, as used for the determination of the PBT properties, may not reflect the real world situation.
Trdili so, da laboratorijski pogoji, kakršni so se uporabljali pri določanju lastnosti PBT, morda ne odražajo realnih razmer.
However, when considering PBT status, the established criteria are based on evaluation of persistence at a soil temperature of 12 °C and this is accepted as mean European temperature.
Vendar pri ocenjevanju PBT uveljavljena merila temeljijo na vrednotenju obstojnosti pri temperaturi tal 12 °C, ki je sprejeta kot povprečna evropska temperatura.
Environmental risks have been identified for this product and special precautions apply.
Za to zdravilo so bila ugotovljena tveganja za okolje, zato veljajo posebni previdnostni ukrepi.
The duration of the uptake (exposure) and depuration phases were 28 and 49 days, respectively.
Faza absorpcije (izpostavljenosti) je trajala 28 dni, faza očiščenja pa 49 dni.
The second study was performed in accordance with the US FDA Environmental Assessment Technical Assistance Document no. 4.087 which is comparable to the current OECD methods.
Druga študija je bila opravljena v skladu z dokumentom za tehnično pomoč pri ocenjevanju vpliva na okolje ameriške agencije FDA št. 4.087, ki je primerljiv s trenutnimi metodami OECD.
It appeared that the therapeutic alternatives to moxidectin do not necessarily have more favourable environmental profiles, in particular in terms of toxicity to aquatic and dung insects.
Izkazalo se je, da terapevtske alternative moksidektinu nimajo nujno ugodnejših okoljskih profilov, zlasti v smislu strupenosti za vodne insekte in insekte v gnoju.
• Moxidectin is inherently toxic to aquatic organisms including fish.
• Moksidektin je inherentno strupen za vodne organizme, vključno z ribami.
Most of these laboratory studies and field studies using incurred residues examined the duration after treatment that did impact dung fauna, rather than attempting to derive effect concentrations.
V večini teh laboratorijskih in terenskih študij, v katerih so uporabljali nakopičene ostanke, so preučevali čas po zdravljenju, v katerem je prišlo do vpliva na organizme v gnoju, niso pa skušali izpeljati koncentracij z učinkom.
The respective risk quotient for moxidectin is 0.01 which is below the trigger value of 1.
Ustrezni količnik tveganja za moksidektin je 0,01, kar je pod sprožitveno vrednostjo 1.
These exclusion times are based on refined risk quotients with refined PEC values.
Ti časi izključenosti temeljijo na natančneje določenih količnikih tveganja z natančneje določenimi vrednostmi PEC.
However, any consideration of risk to the environment must take into account knowledge on the aspects of the specific product and its use that contribute to the actual emission in the environment, e.g. route of administration (pour-on, injectable, oral), husbandry conditions (indoor/outdoor/confined), terrestrial/aquaculture, closed/open water systems, individual animal treatment/flock treatment, control of environmental release, waste management, metabolism in the target animal, etc.
Vendar mora vsaka preučitev tveganja za okolje upoštevati poznavanje vidikov določenega zdravila in njegove uporabe, ki prispevajo k dejanskim emisijam v okolje, npr. pot uporabe (kožni poliv, z injekcijo, peroralno), pogoji reje (v zaprtem prostoru/na odprtem/v omejenem prostoru), kmetijstvo/ribogojstvo, zaprti/odprti vodni sistemi, zdravljenje posameznih živali/črede, nadzor sproščanja v okolje, ravnanje z odpadki, presnova v ciljnih živalih itd.
Data were provided for laboratory (Tier A), extended laboratory with incurred residues (Tier B) and field studies (Tier C).
Predložili so podatke za laboratorijske študije (stopnja A), razširjene laboratorijske študije z nakopičenimi ostanki (stopnja B) in terenske študije (stopnja C).
Altogether, the marketing authorisation holders concluded that the likelihood of moxidectin to bioaccumulate in fish is rather low.
V celoti so imetniki dovoljenj za promet z zdravilom zaključili, da je verjetnost za kopičenje moksidektina v ribah precej majhna.
0.025 (cattle, pour-on)
0,025 (govedo, kožni poliv)
In case of insufficient space on the label: SPECIAL WARNING(S), IF NECESSARY
Če na nalepki ni dovolj prostora: POSEBNO(A) OPOZORILO(A), ČE JE/SO POTREBNO(A)
The LC50 for mortality was established as 37.2 mg/kg; the corresponding NOEC was 20 mg/kg.
Vrednost LC50 za umrljivost je bila določena kot 37,2 mg/kg, ustrezna vrednost NOEC pa je bila 20 mg/kg.