natgillin/translations-raw huggingface dataset:
For cefuroxime-containing products affected by this review (Cefuroxime Alkem, Cefuroxime Krka and Cefuroxime Ingen Pharma), bioequivalence to the EU reference medicinal product was established based on an alternative bioequivalence study conducted at a different facility (study 0258-16, Lambda therapeutic Research Inc.).
Za zdravila, ki vsebujejo cefuroksim, na katera se nanaša ta pregled (Cefuroxime Alkem, Cefuroxime Krka in Cefuroxime Ingen Pharma), je bila bioekivalenca z referenčnim zdravilom, odobrenim v EU, ugotovljena z drugo študijo bioekvivalence, opravljeno v drugi ustanovi (študija 0258-16, Lambda therapeutic Research Inc.).
The arguments of the MAH were considered, including the results of the studies with the US and Australian originator medicines, the data submitted do not address the requirement to demonstrate bioequivalence vis-à-vis an EU reference medicinal product as required by Article 10 of Directive 2001/83/EC.
Argumenti imetnika dovoljenja za promet z zdravilom so bili upoštevani, vključno z rezultati študij z originalnima zdraviloma, odobrenima v ZDA in Avstraliji, vendar se predloženi rezultati ne nanašajo na zahtevo po dokazu bioekvivalence z referenčnim zdravilom, odobrenim v EU, kot zahteva člen 10 Direktive 2001/83/ES.
Where the bioequivalence is not established, safety and efficacy cannot be extrapolated from the EU reference medicinal product to the generic medicinal product as the bioavailability of the active substance between the two medicinal products may differ.
Kjer bioekvivalenca ni ugotovljena, varnosti in učinkovitosti referenčnega zdravila, odobrenega v EU, ni mogoče ekstrapolirati na generično zdravilo, saj se lahko biološka uporabnost učinkovine med zdraviloma razlikuje.
In addition, the MAH presented data to demonstrate that the US and Australian reference medicinal products are similar to the EU reference medicinal product, and that bioequivalence studies comparing the riluzole generic product under discussion to the US and Australian originators concluded in bioequivalence, therefore it is very likely that the product is also bioequivalent to the EU reference medicinal product.
Poleg tega je imetnik dovoljenja za promet z zdravilom predložil podatke, s katerimi je dokazoval, da sta referenčni zdravili, odobreni v ZDA in Avstraliji, podobni zdravilu, odobrenemu v EU, in da so z študijami bioekvivalence, s katerimi so primerjali obravnavano generično zdravilo, ki vsebuje riluzol, z originalnima zdraviloma, odobrenima v ZDA in Avstraliji, dokazali bioekvivalenco, zato je torej zelo verjetno, da je zdravilo biološko enakovredno tudi referenčnemu zdravilu, odobrenemu v EU.
Taking the above into account, the benefit-risk balance of medicinal products for which bioequivalence is not established cannot be considered positive, as the possibility of safety/tolerability or efficacy issues cannot be excluded.
Z upoštevanjem zgoraj navedenega razmerje med tveganji in koristmi zdravil, za katera bioekvivalenca ni ugotovljena, ne more veljati za pozitivno, saj ni mogoče izključiti možnosti pomislekov v zvezi z varnostjo/prenašanjem ali učinkovitostjo.
In the absence of the demonstration of bioequivalence vis-à-vis the EU reference medicinal product, the requirements of Article 10 of Directive 2001/83/EC cannot be considered fulfilled, the efficacy and safety of the concerned medicinal products cannot be established, hence the benefit-risk balance of these medicinal products cannot be considered positive.
Ker bioekvivalenca z referenčnim zdravilom, odobrenim v EU, ni bila dokazana, zahteve člena 10 Direktive 2001/83/ES niso v celoti izpolnjene, varnosti in učinkovitosti zadevnih zdravil pa ni mogoče ugotoviti, zato tudi razmerje med tveganji in koristmi teh zdravil ne more biti pozitivno.
The applicant for the ibuprofen-containing medicinal product affected by the review (Ibuprofen Orion) did not submit alternative data to establish bioequivalence vis-à-vis an EU reference medicinal product.
Predlagatelj za zdravilo, ki vsebuje ibuprofen, na katerega se nanaša ta pregled (Ibuprofen Orion) ni predložil drugih podatkov za ugotavljanje bioekvivalence z referenčnim zdravilom, odobrenim v EU.
For the riluzole-containing medicinal product affected by the review (Riluzole Alkem), the MAH provided some comparative dissolution data to claim that, as the multi-media dissolution profiles of cefuroxime and riluzole are similar to those of the reference products, the probability of the products being bioequivalent is high.
Za zdravilo, ki vsebujejo riluzol, na katero se nanaša ta pregled (Riluzole Alkem), je imetnik dovoljenja za promet z zdravilom predložil nekaj primerjalnih podatkov o raztapljanju in na podlagi tega trdil, da je zaradi podobnosti profilov raztapljanja cefuroksima in riluzola v več medijih profilom raztapljanja referenčnih zdravil verjetnost, da sta zdravili biološko enakovredni, velika.
− Marketing authorisation applications for which no alternative bioequivalence data or a justification was submitted (annex IB).
− vloge za pridobitev dovoljenja za promet z zdravilom, za katere niso bili predloženi alternativni podatki o bioekvivalenci ali utemeljitev (Priloga IB);
− Authorised medicinal products for which alternative bioequivalence data or a justification was submitted but considered insufficient by the CHMP to establish bioequivalence vis-à-vis the EU reference medicinal product (annex IB);
− odobrena zdravila, za katera so bili predloženi alternativni podatki o bioekvivalenci ali utemeljitev, ki pa so bili za odbor CHMP nezadostni, da bi lahko ugotovili bioekvivalenco z referenčnim zdravilom, odobrenim v EU (Priloga IB);
As regards the marketing authorisation application for Ibuprofen Orion, the CHMP considers that the applicant did not establish bioequivalence to the EU reference medicinal product and therefore the marketing authorisation application does not currently fulfil the criteria for authorisation.
Kar zadeva vlogo za pridobitev dovoljenja za promet z zdravilom za zdravilo Ibuprofen Orion, je odbor CHMP menil, da predlagatelj ni dokazal bioekvivalence z referenčnim zdravilom, odobrenim v EU, zato trenutno vloga za pridobitev dovoljenja za promet z zdravilom ne izpolnjuje meril za pridobitev dovoljenja.
This was neither avoided nor detected by the quality management system, which was in place at the site during this time period.
Sistem vodenja kakovosti, vzpostavljen na lokaciji v tem obdobju, tega ni ne preprečil ne zaznal.
If the bioavailability of the generic product is lower than the bioavailability of the reference medicinal product, this may result in a lower than intended exposure to the active substance, leading potentially to a decrease in efficacy, a delay or even a lack of therapeutic effect.
V primeru, da je biološka uporabnost zdravila manjša od biološke uporabnosti referenčnega zdravila, bi to pomenilo, da so bolniki učinkovini izpostavljeni v manjši meri od načrtovane, kar bi lahko povzročilo manjšo učinkovitost, zapoznelo terapevtsko učinkovitost ali celo njeno odsotnost.
If the bioavailability of the generic product is higher than the bioavailability of the reference medicinal product, this may result in a higher than intended exposure of patients to the active substance, leading potentially to an increase in the incidence or severity of adverse effects.
V primeru, da je biološka uporabnost zdravila večja od biološke uporabnosti referenčnega zdravila, bi to pomenilo, da so bolniki učinkovini izpostavljeni v večji meri od načrtovane, kar bi lahko povzročilo večjo pogostnost ali resnost neželenih učinkov.
c. Marketing authorisations for medicinal products for which the bioequivalence vis-à-vis the EU reference medicinal product has been established (annex IA) should be maintained, as the benefit risk balance of these marketing authorisation is considered favourable.
c. Dovoljenja za promet z zdravili, za katera je bila ugotovljena bioekvivalenca z referenčnim zdravilom, odobrenim v EU (Priloga IA), naj se ohranijo, saj je razmerje med tveganji in koristmi za ta dovoljenja za promet z zdravilom ugodno.
d. Bioequivalence vis-à-vis the EU reference medicinal product has been established for marketing authorisation applications listed in annex IA.
d. Bioekvivalenca z referenčnim zdravilom, odobrenim v EU, je bila ugotovljena za vloge za pridobitev dovoljenja za promet z zdravilom, navedene v Prilogi IA.
• The Committee concluded that, for both marketing authorisations and marketing authorisation applications referred to in annex IA, there was alternative data to establish bioequivalence vis-àvis the EU reference medicinal product.
• Odbor je zaključil, da so bili za dovoljenja za promet z zdravilom in vloge za pridobitev dovoljenja za promet z zdravilom iz Priloge IA predloženi alternativni podatki za dokaz bioekvivalenci z referenčnim zdravilom, odobrenim v EU.
The data generated at the site can therefore not be relied upon to establish bioequivalence of products to the EU reference medicinal product.
Ni se torej mogoče zanašati, da bi s podatki, pridobljenimi na lokaciji, ugotovili bioekvivalenco loško enakovrednost zdravil z referenčnim zdravilom, odobrenim v EU.
Therefore CHMP concluded that bioequivalence to the EU reference medicinal product is not established for Riluzole Alkem.
Zato je odbor CHMP zaključil, da za zdravilo Riluzole Alkem bioekvivalenca z referenčnim zdravilom, odobrenim v EU, ni ugotovljena.
b. Marketing authorisation applications for which bioequivalence data or justification were not submitted or considered insufficient by the CHMP to establish bioequivalence vis-à-vis the EU reference medicinal product (annex IB) do not satisfy the criteria for authorisation, as the particulars supporting the marketing authorisations are incorrect and the benefit-risk balance of these marketing authorisation is considered not favourable pursuant to Article 26 of Directive 2001/83/EC.
b. Vloge za pridobitev dovoljenja za promet z zdravili, za katere podatki o bioekvivalenci ali njena utemeljitev niso bili predloženi oziroma za katera je odbor CHMP menil, da zadevni podatki ne zadostujejo za ugotovitev bioekvivalence z referenčnim zdravilom, odobrenim v EU (Priloga IB), ne izpolnjujejo meril za pridobitev dovoljenja, saj podatki v podporo dovoljenjem za promet niso ustrezni in razmerje med tveganji in koristmi za ta dovoljenja za promet z zdravili v skladu s členom 26 Direktive 2001/83/ES ni ugodno.
a. Marketing authorisations for medicinal products for which bioequivalence data or justification were not submitted or considered insufficient by the CHMP to establish bioequivalence vis-à-vis the EU reference medicinal product (annex IB) should be suspended, as the particulars supporting the marketing authorisations are incorrect and the benefit-risk balance of these marketing authorisation is considered not favourable pursuant to Article 116 of Directive 2001/83/EC.
a. Dovoljenja za promet z zdravili, za katera niso bili predloženi podatki o bioekvivalenci ali njena utemeljitev oziroma za katera je odbor CHMP menil, da zadevni podatki ne zadostujejo za ugotovitev bioekvivalence z referenčnim zdravilom, odobrenim v EU (Priloga IB), naj se začasno umaknejo, saj podatki v podporo dovoljenjem za promet niso ustrezni in razmerje med tveganji in koristmi za ta dovoljenja za promet z zdravili v skladu s členom 116 Direktive 2001/83/ES ni ugodno.
Therefore BfArM considered that this affects the trustworthiness of the data generated by the site (clinical and bioanalytical) in the time period from the beginning of the first study in March 2013 until the date when the inspection took place in March 2015, as it must be assumed that critical deficiencies could not be detected by the quality management system at the site in the meantime, because corrective actions and preventive actions (CAPAs) were only implemented after the inspection.
Zato je inštitut BfArM ocenil, da to vpliva na zanesljivost podatkov, pridobljenih na tej lokaciji (kliničnih in bioanalitskih) v obdobju od začetka prve študije marca 2013 do dneva inšpekcijskega pregleda marca 2015.
Alternative data were submitted to demonstrate the bioequivalence of Cefuroxime Alkem, Cefuroxime Krka and Cefuroxime Ingen Pharma to an EU reference medicinal product.
Za dokaz bioekvivalence zdravil Cefuroxime Alkem, Cefuroxime Krka in Cefuroxime Ingen Pharma z referenčnim zdravilom, odobrenim v EU, so bili predloženi alternativni podatki.
The bioequivalence to the EU reference medicinal product is therefore not established.
Bioekvivalenca z referenčnim zdravilom, odobrenim v EU, torej ni ugotovljena.
Having assessed the alternative data, the CHMP recommends the maintenance of the marketing authorisations for Cefuroxime Alkem and Cefuroxime Krka and concludes that, with regards to the Cefuroxime Ingen Pharma marketing authorisation application, bioequivalence has been demonstrated vis-à-vis the EU reference medicinal product using alternative data.
Kar zadeva vlogo za pridobitev dovoljenja za promet z zdravilom za zdravilo Cefuroxime Ingen Pharma, zaključuje, da je bila bioekvivalenca z referenčnim zdravilom, odobrenim v EU, z alternativnimi podatki dokazana.
(as hydroxide)
(kot hidroksid)
• Revaccination Annual.
• Ponovno cepljenje Letno.
• Primary vaccination
• Osnovno cepljenje
Detailed information of this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).
Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/).
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Če opazite kakršne koli stranske učinke, tudi tiste ki niso navedeni v tem navodilu za uporabo ali mislite, da zdravilo ni delovalo, obvestite svojega veterinarja.
Apply usual aseptic procedures.
Ravnajte v skladu z običajnimi načeli asepse.
a) the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
a) bi uporaba zdravila ovirala izvajanje nacionalnega programa za diagnozo, nadzor ali zatiranje živalskih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti pri živih živalih ali živilih ali drugih proizvodih, pridobljenih iz zdravljenih živali.
The level of efficacy for other species may differ from that observed in sheep and cattle.
Učinkovitost pri drugih vrstah se lahko razlikuje od dokazane učinkovitosti pri ovcah in govedu.
(**)Strain-specific pass levels
(**)Sev-specifični nivo
Vaccinate healthy animals only.
Cepite le zdrave živali.
Any person intending to manufacture, import, possess, sell, supply and use of BTVPUR containing serotypes 1, 2, 4 and 8 must first consult the relevant Member State's competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Vsakdo, ki namerava proizvajati, uvažati oziroma vnašati, posedovati, prodajati, oskrbovati in uporabljati to zdravilo s serotipi 1, 2, 4 in 8, se mora najprej posvetovati s pristojnimi organi posamezne države članice o veljavnih programih cepljenja, saj so lahko te dejavnosti prepovedane v državi članici na njenem celotnem ozemlju ali delu ozemlja v skladu z nacionalno zakonodajo.
The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of Bluetongue.
Uporaba tega zdravila za uporabo v veterinarski medicini je dovoljena samo pod posebnimi pogoji, ki jih za nadzor nad boleznijo modrikastega jezika predpisuje zakonodaja Evropske skupnosti.
BOEHRINGER INGELHEIM Animal Health UK Limited Biological Laboratory, Ash Road, Pirbright, Woking, Surrey GU24 0NQ United Kingdom
BOEHRINGER INGELHEIM Animal Health UK Limited Biological Laboratory, Ash Road, Pirbright, Woking, Surrey GU24 0NQ Združeno Kraljestvo
Date of first authorisation: 17/12/2010 Date of last renewal: 08/09/2015
Datum zadnjega podaljšanja dovoljenja za promet: 08/09/2015
The type of strain(s) (two strains at most) included in the final product will be selected based on the epidemiological situation at the time of manufacturing and will be stated on the label.
Tip seva (največ dva seva) vključen v končno zdravilo, bo izbran glede na epidemiološko situacijo ob času proizvodnje cepiva in bo naveden na ovojnini.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini, po EXP.
The duration of immunity for cattle and sheep is 1 year after primary vaccination course.
Trajanje imunosti: pri govedu in ovcah 1 leto po osnovnem cepljenju.
No other adverse reactions except those mentioned in section 4.6 were observed.
Drugi neželeni učinki, razen tistih, ki so navedeni v poglavju 4.6, niso bili opaženi.
Appearance: homogeneous milky white.
Videz: homogen mlečno bel.
For viral culture, inactivation and concentration steps only: MERIAL
Samo za postopke kultivacije virusa, inaktivacije in koncentracije: MERIAL
Avoid multiple vial broaching.
Izogibajte se večkratnemu prebadanju stekleničke.
If used in other domestic and wild ruminant species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of animals prior to mass vaccination.
Ob uporabi cepiva pri drugih domačih in divjih vrstah prežvekovalcev, ki jih ogroža okužba, je potrebna previdnost; priporočljivo je testno cepljenje manjšega števila živali pred masovnim cepljenjem.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Ni podatkov o varnosti ter učinkovitosti tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
- Second injection: after 3-4 weeks.
- Drugi odmerek: po 3-4 tednih.
Store and transport refrigerated (2 ºC - 8 ºC).
Shranjujte in prevažajte v hladilniku (2C - 8C).
Pregnancy and lactation: Can be used during pregnancy and lactation.
Brejost in laktacija: Lahko se uporablja v obdobju brejosti in laktacije.
Laboratory of Lyon Porte des Alpes Rue de l'Aviation, 69800 Saint-Priest France
Laboratory of Lyon Porte des Alpes Rue de l'Aviation, 69800 Saint-Priest Francija
(**) Antigen content (VP2 protein) by immuno-assay
(**) Vsebnost antigena (VP2 protein) z imunološkimi metodami
Incompatibilities: Do not mix with any other veterinary medicinal product.
Inkompatibilnosti: Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini.
The safety and the efficacy of the vaccine have not been established in breeding males.
Varnost in učinkovitost cepiva nista bili ugotovljeni pri plemenjakih.
No other adverse reactions except those mentioned in section ‘Adverse Reactions' were observed.
Drugi neželeni učinki, razen tistih, ki so navedeni v poglavju ‘Neželeni učinki', niso bili opaženi.
Sheep and cattle.
Ovce in govedo.
2.7 mg
2,7 mg saponin
*below the level of detection by the validated RT-PCR method at 3.68 log10 RNA copies/ml, indicating no infectious virus transmission
*pod stopnjo detekcije z validirano metodo RT-PCR pri 3,68 log10 RNA kopijah/ml, ni prenosa virusa
Manufacturer responsible for batch release: MERIAL
Proizvajalec, odgovoren za sproščanje serij: MERIAL
In very rare cases it has been observed a small local swelling at the injection site (at most 32 cm² in cattle and 24 cm² in sheep) which becomes residual 35 days later (≤ 1 cm In very rare cases a transient increase in body temperature, normally not exceeding an average of 1.1 ºC, may occur within 24 hours after vaccination.
V zelo redkih primerih se po cepljenju lahko na mestu dajanja pojavi manjša lokalizirana oteklina (največ 32 cm pri govedu in 24 cm pri ovcah), ki postane rezidualna 35 dni pozneje (≤ 1 cm V zelo redkih primerih se lahko v 24 urah po cepljenju pojavi prehodno povišanje telesne temperature, ki navadno ne preseže povprečja 1,1°C .
In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/ or national Competent Authorities on the current vaccination policies against Bluetongue Virus (BTV).
Pri tej kategoriji živali je potrebno cepivo uporabljati glede na presojo razmerja korist/tveganje odgovornega veterinarja oziroma v skladu z veljavnimi smernicami pristojnih nacionalnih organov glede cepljenja proti bolezni modrikastega jezika (BT).
Sheep and cattle
Ovce in govedo
The vaccine contains inactivated Bluetongue Virus with aluminium hydroxide and saponin adjuvants.
Cepivo vsebuje inaktiviran virus bolezni modrikastega jezika z aluminijevim hidroksidom in saponini kot adjuvansoma.
A confirmatory final potency test by seroneutralisation in rats is conducted when a batch is released.
Končni potrditveni test jakosti je seronevtralizacijski test pri podganah ob sprostitvi serije.
Haemolytic units
Hemolizne enote
Bottle of 10 and 50 ml
Steklenička z 10 in 50 ml
Avoid bubble formation, as this can be irritating at the site of injection.
Izogibajte se nastanku zračnih mehurčkov saj le-ti lahko povzročijo draženje na mestu dajanja.
EXP {month/year} Once broached, use immediately.
EXP {mesec/leto} Odprto zdravilo uporabite takoj.
For purification and bottling steps only: MERIAL Laboratory of Lyon Porte des Alpes Rue de l'Aviation,
Samo za postopke purifikacije in polnjenja: MERIAL Laboratory of Lyon Porte des Alpes Rue de l'Aviation,
Silicon antifoam Phosphate buffer Glycine buffer Aluminium hydroxide Saponin
6.1 Seznam pomožnih snovi silikon (proti penjenju) fosfatni pufer glicerinski pufer aluminijev hidroksid saponin
The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.
SPC, so bodisi dovoljene snovi, za katere tabela 1 priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa ne spadajo v področje uporabe Uredbe (ES) št. 470/2009, kadar so uporabljene tako kot v tem zdravilu za uporabo v veterinarski medicini.
Pharmacotherapeutic group: bluetongue virus vaccine, ATC vet code QI04AA02 (sheep) and QI02AA08 (cattle).
Oznaka ATC vet: QI04AA02 (ovce) in QI02AA08 (govedo).
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Jih ni.
nd injection: after 3-4 weeks
- Drugi odmerek: po 3-4 tednih
10 doses (10 ml) 50 doses (50 ml)
10 odmerkov (10 ml) 50 odmerkov (50 ml)
100 doses (100 ml)
100 odmerkov (100 ml)
Administer one dose of 1 ml subcutaneously according to the following vaccination scheme:
Injicirajte 1 ml v podkožje po naslednjem razporedu:
Polypropylene bottle of 50 or 100 ml with butyl elastomer closure.
50 ali 100 ml polipropilenska plastenka z butil elastomerno zaporko.
Active substance*:
Zdravilne učinkovine*:
10 doses (10 ml) 50 doses (50 ml) 10 x 50 doses (10 x 50 ml) 100 doses (100 ml) 10 x 100 doses (10 x100 ml)
10 odmerkov (10 ml) 50 odmerkov (50 ml) 10 x 50 odmerkov (10 x 50 ml) 100 odmerkov (100 ml) 10 x 100 odmerkov (10 x 100 ml)
Very rare and transient apathy can be observed after the administration of a double-dose of the vaccine.
Zelo redko se lahko po dajanju dvakratnega odmerka cepiva pojavi prehodna apatija.
Type I glass bottle of 10 ml with butyl elastomer closure.
10 ml steklenička (steklo tipa I) z butil elastomerno zaporko.
BTVPUR suspension for injection for sheep and cattle
BTVPUR suspenzija za injiciranje za ovce in govedo
The entire content of the bottle should be used immediately after broaching and during the same procedure.
Takoj po odpiranju porabite celotno vsebino stekleničke.