natgillin/translations-raw huggingface dataset:
It is recommended that a booster dose is given at least 2 months after the second dose, during the child's second year of life.
Priporočljivo je, da se obnovitveni odmerek injicira najmanj dva meseca po drugem odmerku v drugem letu otrokovega življenja.
Synflorix contains small amounts of polysaccharides (a type of sugar) extracted from the ‘capsule' that surrounds the S. pneumoniae bacterium.
Zdravilo Synflorix vsebuje majhne količine polisaharidov (vrste sladkorja), pridobljenih iz „ovojnice“, ki obdaja bakterijo S. pneumoniae.
The study involved almost 5,000 infants aged 3 months and compared an investigational vaccine that contains the same polysaccharides as Synflorix with another vaccine that is not active against S. pneumoniae (in this case, a vaccine against hepatitis A virus).
Študija je vključevala skoraj 5 000 dojenčkov, starih tri mesece, in v njej so cepivo v preskušanju, ki vsebuje enake polisaharide kot zdravilo Synflorix, primerjali z drugim cepivom, ki ni aktivno proti bakteriji S. pneumoniae (v tem primeru cepivo proti virusu hepatitisa A).
Why is Synflorix approved?
Zakaj je bilo zdravilo Synflorix odobreno?
The children in this study were given either Synflorix or a comparator vaccine which was not active against S. pneumoniae and were followed up for an average of 30 months.
Otroci v tej študiji so prejemali zdravilo Synflorix ali primerjalno cepivo, ki ni bilo aktivno proti bakteriji S. pneumoniae; spremljali so jih v povprečju 30 mesecev.
The European Medicines Agency noted that the immune system's response to Synflorix was comparable to its response to another vaccine, which is also authorised for the protection of children against S. pneumoniae in the EU.
Evropska agencija za zdravila je ugotovila, da je bil imunski odziv na zdravilo Synflorix primerljiv z imunskim odzivom na drugo cepivo, ki je prav tako odobreno v EU za zaščito otrok pred okužbo z bakterijo S. pneumoniae.
Synflorix is a vaccine that contains parts of the bacterium Streptococcus pneumoniae (S. pneumoniae, also called pneumococcus).
Zdravilo Synflorix je cepivo, ki vsebuje dele bakterije Streptococcus pneumoniae (S. pneumoniae, imenovane tudi pnevmokoki).
The study compared the immunogenicity of Synflorix with that of another vaccine that is authorised in the EU to protect children against S. pneumoniae infection, and which contains seven of the ten polysaccharides in Synflorix.
V študiji so primerjali imunogenost zdravila Synflorix in drugega cepiva, ki je odobreno v EU za zaščito otrok pred okužbo z bakterijo S. pneumoniae in vsebuje sedem od desetih polisaharidov iz zdravila Synflorix.
It is recommended that a booster dose be given at least 6 months after the third dose.
Priporočljivo je, da se obnovitveni odmerek injicira najmanj šest mesecev po tretjem odmerku.
Based on a comparison of the immune response of Synflorix with the investigational vaccine used in the study, Synflorix is expected to provide similar protection against acute otitis media caused by S. pneumoniae.
Na podlagi primerjave imunskega odziva zdravila Synflorix s cepivom v preskušanju, ki se je uporabljalo v študiji, je pričakovati, da zdravilo Synflorix zagotavlja podobno zaščito pred akutnim vnetjem srednjega ušesa, ki ga povzroča bakterija S. pneumoniae.
Synflorix is a vaccine that protects against infections caused by S. pneumoniae.
Zdravilo Synflorix je cepivo, ki ščiti pred okužbami z bakterijo S. pneumoniae.
Synflorix was evaluated in a large study involving over 30,000 infants below 7 months of age who were given either Synflorix or a comparator vaccine which was not active against S. pneumoniae.
Zdravilo Synflorix so ocenjevali v večji študiji z več kot 30 000 dojenčki, mlajšimi od sedem mesecev, ki so prejemali zdravilo Synflorix ali primerjalno cepivo, ki ni bilo aktivno proti bakteriji S. pneumoniae.
The immune system will then be able to produce antibodies more quickly when it comes into contact with the bacterium again.
Ob ponovni izpostavitvi bakteriji bo imunski sistem tako lahko hitreje tvoril protitelesa.
Pneumococcal polysaccharide conjugate vaccine (adsorbed)
Synflorix cepivo proti pnevmokokom, polisaharidno, konjugirano (adsorbirano)
For the full list of side effects with Synflorix, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Synflorix, glejte navodilo za uporabo.
Synflorix must not be used in children who have a high fever, but it can be given in children who have a mild infection such as a cold. For the full list of restrictions, see the package leaflet.
Zdravilo Synflorix se ne sme uporabljati pri otrocih, ki imajo povišano telesno temperaturo, lahko pa ga jemljejo otroci, ki imajo blago okužbo, na primer prehlad.
Another main study looked at whether Synflorix prevents acute otitis media.
V drugi glavni študiji so proučevali, ali zdravilo Synflorix preprečuje akutno vnetje srednjega ušesa.
It is not intended to provide practical advice on how to use Synflorix.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
How does Synflorix work?
Kako zdravilo Synflorix deluje?
• Premature babies (born between 27 and 36 weeks gestation) are given a course of three doses with an interval of at least one month between each dose, with the first dose given at 2 months of age.
• Nedonošenčki (rojeni med 27. in 36. tednom nosečnosti) prejmejo sklop treh odmerkov v razmaku najmanj enega meseca med posameznimi odmerki, pri čemer se prvi odmerek injicira pri starosti dveh mesecev.
• Infants aged between 6 weeks and 6 months are given a course of three doses with an interval of at least one month between each dose, with the first dose usually given at 2 months of age.
• Dojenčki, stari od šest tednov do šest mesecev, prejmejo sklop treh odmerkov v razmaku najmanj enega meseca med posameznima odmerkoma, pri čemer se prvi odmerek običajno injicira pri starosti dveh mesecev.
How is Synflorix used?
Kako se zdravilo Synflorix uporablja?
• Children aged between 12 months and 5 years are given a course of two doses with an interval of at least 2 months between them.
• Otroci, stari od 12 mesecev do pet let, prejmejo sklop dveh odmerkov v razmaku najmanj dveh mesecev.
• Infants aged between 7 and 11 months are given a course of two doses with an interval of at least one month between them.
• Dojenčki, stari od sedem do enajst mesecev, prejmejo sklop dveh odmerkov v razmaku najmanj enega meseca.
However, these effects have only been observed during early treatment.
Vendar so bili ti učinki opaženi le pri zgodnjem zdravljenju.
This linear extrapolation is questionable, since the processes involved are not linear.
Ta linearna ekstrapolacija je vprašljiva, saj vključeni procesi niso linearni.
Determination of specific conditions
Določitev specifičnih pogojev
requested a re-examination of the CVMP opinion.
zahtevalo ponovno preučitev mnenja odbora CVMP.
However, more studies are required to fill remaining data gaps in this area and to confirm these effects.
Vendar bo potrebnih še več študij, ki bodo zapolnile vrzeli v podatkih s tega področja in potrdile te učinke.
Reduction of global use of antibiotics
Zmanjšanje vsesplošne uporabe antibiotikov
The administration period was 14 or 21 days immediately after weaning.
Obdobje dajanja je bilo 14 ali 21 dni takoj po odstavitvi.
The margin of safety for the target animals at the dose stated above is relatively small but acceptable.
Meja varnosti za ciljne živali pri navedenem odmerku je razmeroma nizka, vendar sprejemljiva.
Risks of (co-)selection of resistant bacteria
Tveganja za (ko)selekcijo odpornih bakterij
However, the importance of these findings to animal and public health remains unclear due to gaps in the available knowledge.
Vendar pa pomen teh ugotovitev za živali in javno zdravje zaradi vrzeli v razpoložljivem znanju še ni jasen.
The CVMP concluded that when using the added risk approach, then:
Odbor CVMP je zaključil, da je pri uporabi pristopa dodanega tveganja:
The margin of safety can be considered as lower than 3 times the recommended dose.
Šteje se, da je meja varnosti nižja od trikratnega priporočenega odmerka.
Every active substance in a fixed combination should be indicated for use at the moment of treatment and administered in the correct dose.'
Vsaka zdravilna učinkovina v fiksni kombinaciji mora biti indicirana za uporabo v času zdravljenja in dana v pravilnem odmerku.“
The fact that LAMRSA CC398 has currently a low impact on human populations does not negate the public health concerns.
Dejstvo, da ima LA-MRSA CC398 trenutno majhen vpliv na človeško populacijo, ne pomeni, da ni tveganja za javno zdravje.
The bioavailable fraction of zinc in soils is small (<1%).
Biološko uporabni delež cinka v tleh je majhen (< 1 %).
No synergy was demonstrated and the potential antagonism was not tested.
Sinergijski učinek ni bil dokazan in morebitnega antagonizma niso preskušali.
This restricts the focus to the findings of Poulsen (1995), and Holm (1990)27.
Tako se lahko osredotočimo samo na ugotovitve Poulsena (1995) in Holma (1990)27.
It has to be noted that the PNECs used in this study is adapted to Danish situations and may be lower (more worst-case) in other parts of Europe with different soil types.
Opozoriti je treba, da so bile vrednosti PNEC, uporabljene v tej študiji, prilagojene danskim razmeram in so morda nižje (slabši primer) kot v drugih delih Evrope z drugačnimi vrstami tal.
It should be noted that the CVMP is a scientific Committee and that while it operates within the framework of the Union legislation regulating veterinary medicinal products, it cannot discuss the specific merits of procedural and legal aspects of administrative procedures laid down in the legislation.
Opozoriti je treba, da je CVMP znanstveni odbor in da kljub temu, da deluje v okviru zakonodaje Unije, ki ureja zdravila za uporabo v veterinarski medicini, ne more razpravljati o konkretni vsebini postopkovnih in pravnih vidikov upravnih postopkov, ki jih predvideva zakonodaja.
Re-examination procedure
Postopek ponovne preučitve
Risks for the environment
Tveganja za okolje
It appears that one-week of administration is not sufficiently efficacious and a duration longer than 14 days is not justified either.
Zdi se, da enotedensko dajanje ni dovolj učinkovito, več kot 14-dnevno trajanje pa ni utemeljeno.
Shorter or longer treatment durations were considered not supported by sufficient data.
Ocenjeno je bilo, da krajše ali daljše trajanje zdravljenja ni podprto z zadostnimi podatki.
For this 30% contribution alone a risk is already identified for Danish soils.
Za danska tla je bilo tveganje ugotovljeno že pri tem 30-odstotnem prispevku.
This is not only applicable on farms where dilution of manure is not possible, but also for farms that are able to dilute manure.
To ne velja le za kmetije, na katerih redčenje gnoja ni mogoče, temveč tudi za kmetije, na katerih je to mogoče.
List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, route of administration, applicants and marketing authorisation holders in the Member States
Seznam imen, farmacevtskih oblik, jakosti zdravil za uporabo v veterinarski medicini, živalskih vrst, poti uporabe, predlagateljev in imetnikov dovoljenj za promet z zdravilom v državah članicah
In sandy soils, PNECs were exceeded in 66% of all cases.
V peščenih tleh so bile vrednosti PNEC presežene pri 66 % primerov.
CVMP overall conclusions after re-examination
Končni zaključki odbora CVMP po ponovni preučitvi
In 45% of all soil samples, PNECs were already exceeded.
Pri 45 % vseh vzorcev prsti so bile vrednosti PNEC že presežene.
At present it is uncertain as to what represents a reasonable worst case exposure scenario for the manure application rate.
Trenutno ni jasno, kaj pomeni razumen najslabši možen scenarij izpostavljenosti glede odmerka gnoja.
At higher dose (x3 during 28 days) significant side effects (impact on growth rate, clinical signs) have been observed.
Pri večjem odmerku (x3 v obdobju 28 dni) so bili opaženi pomembni neželeni učinki (vpliv na hitrost rasti, klinične znake).
Huvepharma N.V.
Družba Huvepharma N.V.
A, Animal Sci. 45: 159-167.
A, Animal Sci. 45: 159-167. 1995. 9 Lima GJM,
The marketing authorisation holders' grounds for the re-examination were submitted before 6 February
Imetniki dovoljenj za promet z zdravilom so razloge za ponovno preučitev predložili pred 6. februarjem 2017.
In the absence of relevant diagnostic data it was not possible to identify the pathogens involved.
Ker ni bilo na voljo ustreznih diagnostičnih podatkov, ni bilo mogoče določiti vključenih patogenov.
No dose determination study or justification of the selected dose is given, neither confirmatory data supporting an optimal duration of administration of 14 days.
Prav tako ni bila predložena nobena študija za določitev odmerka ali utemeljitev izbranega odmerka niti potrditveni podatki, ki bi podpirali optimalno trajanje dajanja 14 dni.
Diarrhoea was observed only during the first two weeks after weaning.
Drisko so opazili le v prvih dveh tednih po odstavitvi.
Contamination of soil and water systems by heavy metals, such as zinc, is currently difficult to remedy with existing technologies.
Onesnaženje tal in vode s težkimi kovinami, kot je cink, je trenutno z obstoječimi tehnologijami težko odpraviti.
No study was conducted with the combination in the proposed indication and thus the clinical benefit of the association was not demonstrated.
S kombinacijo pri predlagani indikaciji ni bila izvedena nobena študija, zato klinična korist kombinacije ni bila dokazana.
The efficacy in piglets weaned later is not documented neither in less intensive breeding conditions.
Učinkovitost pri pozneje odstavljenih prašičkih tudi v manj intenzivnih vzrejnih pogojih ni dokumentirana.
This duration of treatment differs from all other products containing zinc oxide (i.e. 14 consecutive days).
To trajanje zdravljenja se razlikuje od trajanja pri vseh drugih zdravilih, ki vsebujejo cinkov oksid (tj. 14 dni zapored).
Therefore, in the absence of more data, it is not possible to further characterise the risk posed to both public and animal health.
Zaradi pomanjkanja podatkov zato ni mogoče nadalje opredeliti tveganja za javno zdravje in zdravje živali.
And when using the bioavailability correction, then:
Pri uporabi popravka zaradi biološke uporabnosti bo:
The CVMP considers that four out of five environmental risk assessments have a number of deficiencies on their risk assessment and consequently cannot be used in support of the benefit-risk assessment.
Odbor CVMP meni, da imajo štiri od petih ocen tveganja za okolje številne pomanjkljivosti glede ocene tveganja in jih zato ni mogoče uporabiti v podporo oceni razmerja med tveganji in koristmi.
Colistin alone is sufficiently effective for the metaphylaxis and treatment of gastrointestinal infections caused by non-invasive E. coli (see procedure EMEA/V/A/106)10.
Kolistin je sam po sebi dovolj učinkovit za metafilakso in zdravljenje prebavnih okužb, ki jih povzroča neinvazivna E. coli (glejte postopek EMEA/V/A/106)10.
All data provided for zinc oxide only refer to a prevention claim.
Vsi predloženi podatki za cinkov oksid se nanašajo samo na trditev o preprečevanju.
The data presented identify a hazard for human and animal health but, at the present time, that risk is not quantifiable.
Predstavljeni podatki kažejo na nevarnost za zdravje ljudi in živali, vendar trenutno tveganja ni mogoče količinsko opredeliti.
No clinical data was identified to support the claimed indication ‘prevention and treatment of various types of diarrhoea occurring at the weaning'.
Predloženi niso bili nobeni klinični podatki, ki bi podpirali navedeno indikacijo „preprečevanje in zdravljenje različnih vrst driske, ki se pojavi ob odstavitvi“.
Potential additional exposure concentrations, e.g., from feed additives containing zinc or other industrial sources, have not been taken into account for this environmental risk assessment.
Morebitna dodatna izpostavljenost, npr. iz dodatkov krmi, ki vsebujejo cink, ali drugih industrijskih virov, v tej oceni tveganja za okolje ni bila upoštevana.
The marketing authorisation holders informed the EMA that they had not received the official notification of the inclusion of their products (Pigzin and ZincoTec) in this Article 35 referral procedure.
Imetnika dovoljenja za promet z zdravilom sta obvestila agencijo EMA, da nista prejela uradnega obvestila o vključitvi njunih zdravil (Pigzin in ZinvoTec) v ta napotitveni postopek v skladu s členom 35.
As a result, procedural and legal considerations are not within the remit of the CVMP; therefore during the re-examination of the present referral procedure the CVMP considered only the marketing authorisation holders' scientific grounds for reexamination.
Postopkovni in pravni vidiki torej niso v pristojnosti odbora CVMP, zato je ta pri ponovni preučitvi tega napotitvenega postopka upošteval samo znanstvene razloge imetnikov dovoljenj za promet z zdravilom za preučitev.
The exposure assessment should ideally have addressed this and considered a realistic worst-case situation with respect to the respective receiving environmental compartments.
Ocena izpostavljenosti bi morala to v idealnem primeru upoštevati in obravnavati realno najslabše možno stanje glede na ustrezne sprejemne ekosisteme.
It has to be noted that bioavailability was not considered but the PNECs used in this study were higher (less worst-case) than those reported in the EU RAR and that the annual application of manure was based on 140 kg/N/ha/year which is less worst-case than the European limit for sensitive soils of 170 kg/N/ha/year.
Treba je omeniti, da biološka uporabnost ni bila upoštevana, vendar so bile vrednosti PNEC, uporabljene v tej študiji, večje (nenajslabši primer) od vrednosti, navedenih v poročilu EU RAR, in da je letni vnos gnoja temeljil na odmerku 140 kg/N/ha/leto, kar je boljši primer kot evropska mejna vrednost za občutljiva tla z odmerkom, ki znaša 170 kg/N/ha/leto.
Huvepharma's scientific grounds for re-examination focused on risks for the environment.
Znanstveni razlogi družbe Huvepharma za ponovno preučitev so se osredotočali na tveganja za okolje.
To conclude on this point, the marketing authorisation holders did not provide any additional data that will change the original CVMP conclusion with regard to efficacy.
Zaključiti je mogoče, da imetnika dovoljenja za promet z zdravilom nista predložila dodatnih podatkov, ki bi spremenili prvotni zaključek odbora CVMP glede učinkovitosti.
However, it is noted that the level of uncertainty in the risk characterisation for sediment is considerably greater than for soil or surface waters given that bioavailability considerations were harder to take into account.
Treba pa je opozoriti, da je stopnja negotovosti bistveno večja pri opredelitvi tveganja za sedimente kot za tla ali površinske vode, saj je bilo biološko uporabnost težje upoštevati.
It is still difficult at present time to define the situations in which the zinc oxide containing products will be beneficial or not beneficial.
Trenutno je še vedno težko opredeliti primere, v katerih so zdravila, ki vsebujejo cink, koristna, oziroma v katerih niso koristna.
To manage the risks and determine adequate risk mitigation measures, the marketing authorisation holders suggest adding a number of statements on the product information regarding the mixing and/or spreading of manure to land.
Za obvladovanje tveganj in določitev ustreznih ukrepov za zmanjšanje tveganja imetnika dovoljenj za promet z zdravilom predlagata, da se v informacije o zdravilu doda več izjav o mešanju in/ali vnosu gnoja na zemljišča.
Moreover the data provided only concern separate use of colistin and zinc oxide and not the clinical use of the
Poleg tega se predloženi podatki nanašajo samo na ločeno uporabo kolistina in cinkovega oksida in ne na klinično uporabo
In the trials with only seven days of zinc oxide supplementation at the recommended dose no significant effect was shown.
Pri preskušanjih s samo sedemdnevnim dodajanjem cinkovega oksida v priporočenem odmerku ni bil dokazan pomemben učinek.
Actually, the use of veterinary medicinal products containing zinc oxide contributes to about 30% of the total zinc present in manure.
Dejansko uporaba zdravil za uporabo v veterinarski medicini, ki vsebujejo cinkov oksid, prispeva k približno 30 % skupnega cinka, prisotnega v gnoju.
Consequently an ‘ageing' factor of 3 has been established and is used in calculating site-specific PNECs.
Zato je bil določen faktor „staranja“ v vrednosti 3, ki se uporablja za izračun vrednosti PNEC, specifičnih za posamezno mesto.
A reduction in the use of antimicrobials to treat post-weaning diarrhoea in piglets is likely to reduce the selective pressure for antimicrobial resistance development.
Z manjšo uporabo protimikrobnih učinkovin za zdravljenje driske po odstavitvi pri prašičkih se bo verjetno zmanjšal selektivni pritisk za razvoj protimikrobne odpornosti.
Also, piglets are weaned between 3-4 weeks of age (i.e. 7-8 kg), but the claim for the aforementioned products is for pigs up to 40 kg bw.
Poleg tega so bili prašički odstavljeni v starosti 3-4 tedne (tj. pri 78 kg), navedba za navedeni zdravili pa velja za prašiče do 40 kg telesne mase.
For each compartment (soil, water and sediment), zinc bioavailability is dependent on various biotic and abiotic factors.
V vsakem ekosistemu (tleh, vodi in sedimentih) je biološka uporabnost cinka odvisna od različnih biotskih in abiotskih dejavnikov.
No studies were submitted to support the treatment indication.
Študije, ki bi podpirale indikacijo zdravljenja, niso bile predložene.
A critical consideration in relation to assessing environmental risk of metals is determining their bioavailability.
Ključni vidik pri ocenjevanju tveganja, ki ga za okolje predstavljajo kovine, je določanje njihove biološke uporabnosti.
Some of the grounds for re-examination raised by the marketing authorisation holders related to considerations of a procedural and legal nature.
Nekateri razlogi za ponovno preučitev, ki so jih navedli imetniki dovoljenj za promet z zdravilom, so se nanašali na pomisleke postopkovne in pravne narave.
However, after the cessation of zinc oxide supplementation at day 14, acids were added in the feed and consequently the effects of each component could not be evaluated during the follow-up period.
Po prenehanju dodajanja cinkovega oksida po 14 dneh so v krmo dodali kisline, zato v obdobju spremljanja ni bilo mogoče oceniti učinkov posamezne komponente.
Nevertheless there remains the potential risk of overuse of zinc oxide, as it is not possible to predict which animals will develop diarrhoea, as some cases of diarrhoea at weaning are only transitory and slight and without impact on general health of the animals.
Kljub temu še vedno obstaja morebitno tveganje za čezmerno uporabo cinkovega oksida, saj ni mogoče napovedati, pri katerih živalih se bo driska pojavila, ker so nekateri primeri driske ob odstavitvi le prehodne in blage narave ter ne vplivajo na splošno zdravstveno stanje živali.
Given that the VICH and CVMP guidelines16,17,18 on the Phase II environmental risk assessment of veterinary medicinal products are not primarily developed for inorganic molecules, many of the assumptions and exposure models described in the guidelines are unsuitable for a substance such as zinc.
Ker smernice odbora VICH in odbora CVMP16,17,18 o oceni tveganja za okolje faze II zdravil za uporabo v veterinarski medicini predvsem niso bile pripravljene za anorganske molekule, številne predpostavke in modeli izpostavljenosti, opisani v smernicah, niso primerni za snov, kot je cink.
The clinical relevance of zinc oxide in reducing the level of E. coli diarrhoea for these heavier pigs is unknown.
Klinični pomen cinkovega oksida pri zmanjševanju stopnje driske zaradi E. coli pri teh težjih prašičih ni znana.
However, the only authorised indications are for the treatment and control of diarrhoea in piglets.
Vendar sta edini odobreni indikaciji zdravljenje in obvladovanje driske pri prašičkih.
AVS is produced by bacteria in anoxic sediments.
AVS proizvajajo bakterije v anoksičnih sedimentih.