natgillin/translations-raw huggingface dataset:
The company presented the results of studies carried out in 24 healthy volunteers looking at the effect of the Marvel insulins on blood sugar levels, compared with the Humulin insulins.
Podjetje je predložilo rezultate študij, izvedenih s 24 zdravimi prostovoljci, v katerih so preučevali učinek insulinov Marvel na raven sladkorja v krvi v primerjavi z insulini Humulin.
The application was at day 120 when the company withdrew.
Podjetje je vlogo umaknilo na 120. dan postopka.
• Insulin Human 30/70 Mix Marvel: 30% soluble insulin and 70% isophane insulin.
• Insulin Human 30/70 Mix Marvel: 30 % topnega insulina in 70 % insulina izofana.
• Insulin Human Rapid Marvel: soluble insulin,
• Insulin Human Rapid Marvel: topni insulin,
On 20 December 2007, Marvel LifeSciences Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its applications for marketing authorisations for Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel, for the treatment of diabetes mellitus.
Podjetje Marvel LifeSciences Ltd. je dne 20. decembra 2007 obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da se je odločilo umakniti vloge za izdajo dovoljenj za promet z zdravili Insulin Human Rapid Marvel, Insulin Human Long Marvel in Insulin Human 30/70 Mix Marvel, namenjenimi za zdravljenje sladkorne bolezni.
Therefore, at the time of the withdrawal, the CHMP's view was that Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel could not be considered as biosimilar to the reference medicinal products Humulin S, Humulin I and Humulin M3.
CHMP je bil zato v času umika mnenja, da zdravil Insulin Human Rapid Marvel, Insulin Human Long Marvel in Insulin Human 30/70 Mix Marvel ni mogoče obravnavati kot podobna referenčnim zdravilom Humulin S, Humulin I and Humulin M3.
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING AUTHORISATION APPLICATION for INSULIN HUMAN RAPID MARVEL INSULIN HUMAN LONG MARVEL INSULIN HUMAN 30/70 MIX MARVEL
VPRAŠANJA IN ODGOVORI GLEDE UMIKA VLOGE ZA DOVOLJENJE ZA PROMET za zdravila INSULIN HUMAN RAPID MARVEL INSULIN HUMAN LONG MARVEL INSULIN HUMAN 30/70 MIX MARVEL
Based on the review of the data, the CHMP had some concerns and was of the provisional opinion that Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel could not have been approved for the treatment of diabetes mellitus.
Na podlagi pregleda podatkov je imel CHMP določene zadržke in bil začasnega mnenja, da za zdravila Insulin Human Rapid Marvel, Insulin Human Long Marvel in Insulin Human 30/70 Mix Marvel ni mogoče odobriti dovoljenja za zdravljenje sladkorne bolezni.
What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with Insulin Human Rapid Marvel, Insulin Human Long Marvel or Insulin Human 30/70 Mix Marvel?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preizkušanjih/programih sočutne uporabe zdravil Insulin Human Rapid Marvel, Insulin Human Long Marvel in Insulin Human 30/70 Mix Marvel?
• Insulin Human Long Marvel: isophane insulin,
• Insulin Human Rapid Marvel: insulin izofan,
What are Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel?
Kaj so zdravila Insulin Human Rapid Marvel, Insulin Human Long Marvel in Insulin Human 30/70 Mix Marvel?
Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel were to be ‘biosimilar' medicines.
Zdravila Insulin Human Rapid Marvel, Insulin Human Long Marvel in Insulin Human 30/70 Mix Marvel naj bi bila „podobna biološka“ zdravila.
Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel are replacement insulins, which contain an active substance that is identical to the insulin made by the pancreas.
Zdravila Insulin Human Rapid Marvel, Insulin Human Long Marvel in Insulin Human 30/70 Mix Marvel so nadomestni insulini, ki vsebujejo zdravilno učinkovino, enako insulinu, ki ga tvori trebušna slinavka.
A procedure under Article 29(4) was therefore triggered in June 2012.
Zato se je junija 2012 začel postopek na podlagi člena 29(4).
Glimepiride has been authorised in the EU since 1996.
V EU je odobren od leta 1996.
This implies that the composition of the different strengths will have the same impact on the in vivo absorption.
To pomeni, da bo imela sestava pri različnih jakostih enak učinek na absorpcijo in vivo.
• the CHMP reviewed the available data and the justifications submitted by the Applicant,
• Odbor CHMP je pregledal dostopne podatke in utemeljitve predlagatelja;
Overall summary of the scientific evaluation of Glimepirida Parke-Davis and associated names (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravila Glimepirida ParkeDavis in povezanih imen (glej Prilogo I)
The Applicant therefore only performed the required bioequivalence studies.
Torej je izvedel le zahtevane študije biološke enakovrednosti.
Finally, the Applicant stated that glimepiride exhibits linear pharmacokinetic properties.
Nazadnje je še navedel, da glimepirid kaže linearne farmakokinetične lastnosti.
Regarding the risk for incomplete dissolution, the CHMP considered that the test and reference formulations exhibited a similar performance, indicating a similar risk for all formulations.
Kar zadeva tveganje nepopolnega raztapljanja, je menil, da sta se testna in referenčna formulacija obnašali podobno, kar kaže na podobno tveganje za vse formulacije.
As a result, all tablet strengths have the same average weight (170 mg) and identical qualitative and quantitative composition in terms of functional excipients, with the exception of small differences in the quantity of the filler lactose monohydrate, which is used proportionally to compensate for the differences in the active substance content (less than 5 % of the total tablet weight) resulting from the range of tablet strengths.
Posledično imajo vse jakosti tablet enako povprečno maso (170 mg) ter enako kakovostno in količinsko sestavo z vidika funkcionalnih pomožnih snovi, razen manjših razlik v količini polnila laktoza monohidrata, ki se uporablja sorazmerno za izravnavo razlik v vsebnosti zdravilne učinkovine (manj kot 5 % skupne mase tablet), kar je posledica različnih jakosti tablet.
Regarding the drug substance particle size, the Applicant stated that a micronized grade of glimepiride is used, ensuring that 95% of the particles are below 10μm and 50% of the particles are below 4μm.
V zvezi z velikostjo delcev zdravilne učinkovine je navedel, da se uporablja mikronizirani glimepirid, kar pomeni, da je 95 % delcev manjših od 10 μm, 50 % delcev pa manjših od 4 μm.
Glimepiride is a second generation sulphonylurea anti-hyperglycaemic agent used in patients with type 2 diabetes mellitus insufficiently controlled by diet and exercise alone or in combination with insulin in patients in whom diet and exercise plus oral anti-hyperglycaemic therapy have failed to control blood glucose.
Glimepirid je druga generacija antihiperglikemičnih učinkovin iz skupine sulfonilsečnin za uporabo pri bolnikih s sladkorno boleznijo tipa 2 (diabetes mellitus tipa 2), ki ni zadostno nadzorovana samo z dieto in telesno dejavnostjo, ali za uporabo skupaj z insulinom pri bolnikih, pri katerih z dieto in telesno dejavnostjo ter terapijo s peroralnimi antihiperglikemičnimi zdravili ni bilo mogoče nadzorovati glukoze v krvi.
the CHMP has recommended the granting of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Glimepirida Parke-Davis and associated names (see Annex I).
je odbor CHMP priporočil odobritev dovoljenja za promet z zdravilom, katerega povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo ostanejo enaki kot končne različice, dogovorjene med postopkom Usklajevalne skupine, kot je navedeno v Prilogi III za zdravilo Glimepirida Parke-Davis in povezana imena (glej Prilogo I).
The Applicant submitted a marketing authorisation application for Glimepirida Parke-Davis, based on claims of essential similarity to the marketed reference product.
Predlagatelj je predložil vlogo za pridobitev dovoljenja za promet z zdravilom Glimepirida Parke-Davis na podlagi trditev o bistveni podobnosti z referenčnim zdravilom na trgu.
In addition, the fraction of absorbed glimepiride is consistently described as being non dose-dependent and close to 100%, as evidenced from the rapid and complete absorption from the gastro-intestinal tract with linear increase in Cmax and AUC.
Poleg tega se frakcija absorbiranega glimepirida dosledno opisuje kot neodvisna od odmerka in skoraj 100-odstotna, kar se kaže v hitri in popolni absorpciji v prebavnem traktu z linearnim povečevanjem največje koncentracije (Cmax) in površine pod krivuljo (AUC).
The Applicant also stated that the proposed tablets are developed as look-alike formulations.
Navedel je še, da so predlagane tablete zasnovane na podlagi „dvojniških formulacij“.
The CHMP considered that the dissolution studies confirmed that the low dissolution of glimepiride is related to the drug substance rather than to the formulation and that all strengths of the proposed product have similar qualitative and quantitative compositions, leading to similar in vivo absorption.
Pri tem je menil, da so študije v zvezi z raztapljanjem potrdile, da se slaba topnost glimepirida navezuje na zdravilno učinkovino in ne na formulacijo ter da imajo vse jakosti predlaganega zdravila enako kakovostno in količinsko sestavo, kar vodi do podobne absorpcije in vivo.
The CHMP was therefore of the opinion that the benefit-risk ratio of Glimepirida Parke-Davis and associated names is favourable.
Zato je po njegovem mnenju razmerje med koristmi in tveganji zdravila Glimepirida Parke-Davis in povezanih imen ugodno.
• the CHMP considered the conducted bioequivalence study to be adequate to demonstrate bioequivalence between the proposed and the reference products,
• Menil je, da je bila izvedena študija biološke enakovrednosti primerna kot dokaz biološke enakovrednosti med predlaganim in referenčnim zdravilom;
However, concerns were raised regarding the evidence of bioequivalence, considering the study conducted with the 1 mg tablet to be insufficient to provide evidence of bioequivalence for the higher strengths, as bioequivalence studies for substances with low solubility should be conducted at the highest strength according to the CHMP Guideline on the Investigation of Bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1/ Corr), unless the active substance is highly soluble or if there are safety/tolerability reasons.
Vendar so bili v zvezi s študijo, opravljeno z 1-miligramsko tableto, izraženi pomisleki, da za večje jakosti ni dovolj dokazov o biološki enakovrednosti, saj bi bilo treba študije biološke enakovrednosti za slabo topne snovi opraviti pri največji jakosti, kot je to določeno v Smernicah Odbora za zdravila za uporabo v humani medicini (CHMP) o raziskavah biološke enakovrednosti („CHMP Guideline on the Investigation of Bioequivalence“, CPMP/EWP/QWP/1401/98 Rev. 1/Corr), razen če je zdravilna učinkovina dobro topna ali za to obstajajo varnostni/tolerančni razlogi.
The CHMP also reviewed the biopharmaceutical data and agreed that the proposed and the reference products have similar dissolution profiles, when comparing the 1 mg and the 4 mg strengths separately.
Proučil je tudi biofarmacevtske podatke in se strinjal, da imata predlagano in referenčno zdravilo podoben profil raztapljanja, kadar ločeno primerjamo 1-miligramsko in 4-miligramsko jakost.
With such a low rate of dissolution, the Applicant considered that even the 1 mg strength possesses enough sensitivity to detect formulation differences.
Menil je, da je ob tako nizki stopnji raztapljanja že 1-miligramska jakost dovolj občutljiva, da omogoča zaznavanje razlik v formulaciji.
The CHMP assessed the Applicant justifications and agreed that glimepiride is associated with a risk of hypoglycaemic reactions, in particular in healthy subjects, including at the lowest 1 mg dose.
Odbor CHMP se je po oceni predlagateljevih utemeljitev strinjal, da je glimepirid povezan s tveganjem hipoglikemičnih reakcij, še zlasti pri zdravih preskušancih, in sicer tudi pri najnižjem 1-miligramskem odmerku.
The Applicant also considered that the observed decrease in drug dissolution could be solely attributed to the inherent characteristics of glimepiride and not to formulation differences.
Hkrati je še menil, da je mogoče ugotovljeno manjše raztapljanje zdravilne učinkovine pripisati le temeljnim značilnostim glimepirida, ne pa razlikam v formulaciji.
The CHMP considered that a further bioequivalence study using the 4 mg dose is not anticipated to provide significantly better discriminatory power between the different formulations, given the biopharmaceutical features of this glimepiride formulation and that such a study would therefore be unnecessary and ethically unacceptable, given the risk of hypoglycaemia.
Odbor je menil, da nadaljnja študija biološke enakovrednosti s 4miligramskim odmerkom - ob upoštevanju biofarmacevtskih lastnosti te formulacije glimepiridaverjetno ne bi zagotovila bistveno boljše diskriminacijske moči med posameznimi formulacijami, zato bi bila taka študija nepotrebna, zaradi tveganja hipoglikemične reakcije pa bi bila tudi etično nesprejemljiva.
The Applicant subsequently explored the acceptability of conducting a study using the 1 mg tablet in order to waive studies using the higher strengths.
Zato je proučil dopustnost izvedbe študije z uporabo 1-miligramske tablete, da bi se tako izognil študijam z uporabo večjih jakosti.
The Applicant investigated the solubility of drug substance across the physiological pH range and confirmed the very low solubility of glimepiride.
Proučil je topnost zdravilne učinkovine v razponu fiziološkega pH in potrdil ugotovitev, da je glimepirid zelo slabo topen.
The CHMP therefore considered that the conducted fasting bioequivalence study using the 1 mg strength was acceptable and adequate to demonstrate bioequivalence between test and reference formulations, while ensuring the safety of the study subjects.
Zato je menil, da je bila izvedena študija biološke enakovrednosti z uporabo 1-miligramske jakosti na tešče sprejemljiva in primerna kot dokaz biološke enakovrednosti med testno in referenčno formulacijo, z njo pa je bila zagotovljena tudi varnost sodelujočih v študiji.
The CHMP also considered that the presented biopharmaceutical and pharmacokinetic data confirmed the adequate sensitivity of the bio-analytical method and further supported the acceptability of the requested biowaiver for the 2, 3 and 4 mg strengths.
Poleg tega je še menil, da predloženi biofarmacevtski in farmakokinetični podatki potrjujejo primerno občutljivost bioanalitične metode ter dodatno dokazujejo, da je zahtevano izvzetje iz obveznosti izvedbe študij biološke enakovrednosti za 2-, 3- in 4miligramsko jakost dopustno.
The CHMP assessed the open label, randomized, comparative bioavailability study of glimepiride 1 mg tablets under fasting conditions and the Applicant justifications for the design of the study.
Odbor CHMP je ocenil odprto klinično randomizirano primerjalno študijo biološke uporabnosti 1-miligramskih tablet glimepirida pri uporabi na tešče in utemeljitve predlagatelja v zvezi z zasnovo študije.
Having reviewed the available literature, the Applicant concluded that fasting studies involving glimepiride appeared to be associated with a considerable risk of hypoglycaemia, even with the 1 mg dose.
Ob pregledu dostopne literature je ugotovil, da je mogoče študije, ki so bile opravljene na tešče in so vključevale glimepirid, očitno povezati s precejšnjim tveganjem hipoglikemične reakcije, in sicer tudi pri uporabi 1-miligramskega odmerka.
The CHMP was therefore of the view that absorption is not dependent or limited by in vivo drug dissolution and that the low solubility of glimepiride does not prevent granting a biowaiver for the 2, 3 and 4 mg strengths.
Zato je menil, da absorpcija ni niti odvisna od raztapljanja zdravilne učinkovine in vivo niti ni zaradi tega omejena ter da je mogoče kljub slabi topnosti glimepirida odobriti izvzetje iz obveznosti izvedbe študij biološke enakovrednosti („biowaiver“) za 2-, 3- in 4-miligramsko jakost.
• the CHMP considered the requested biowaiver for the 2, 3 and 4 mg strengths to be acceptable,
• Prav tako je menil, da je zahtevano izvzetje iz obveznosti izvedbe študij biološke enakovrednosti za 2-, 3- in 4-miligramsko jakost dopustno,
The Applicant stated that it considered the ethical concerns linked to the risk of hypoglycaemia in healthy adults when designing the bioequivalence study.
Predlagatelj je navedel, da je ob zasnovi študije biološke enakovrednosti upošteval etične pomisleke v zvezi s tveganjem hipoglikemične reakcije pri zdravih odraslih osebah.
The CHMP was therefore of the view that differences between the different strengths with regard to the in vivo rate of drug release are very unlikely.
Zato po njegovem mnenju ni zelo verjetno, da bi razlike med posameznimi jakostmi vplivale na sproščanje zdravilne učinkovine in vivo.
The CHMP also considered the fact that the particle size of the active substance is controlled to be reassuring.
Menil je še, da k večji gotovosti pripomore tudi dejstvo, da je zagotovljen nadzor nad velikostjo delcev zdravilne učinkovine.
In conclusion, the CHMP was of the opinion that the exceptional conditions relating to safety referred to in the Guideline on the Investigation of Bioequivalence are applicable to this particular application, despite the recommendation that bio-equivalence studies should be performed with the highest strength for substances with low solubility.
Odbor CHMP je zato menil, da se v tem posebnem primeru kljub priporočilu, da je treba študije biološke enakovrednosti za slabo topne snovi opraviti pri največji jakosti, uporabljajo posebni pogoji v zvezi z varnostjo iz Smernic CHMP o raziskavah biološke enakovrednosti.
Packaging Content (concentration)
Farmacevtska oblika Pot uporabe Ovojnina Vsebina (koncentracija)
Package size l t o r
3 mg/ml
Strength Pharmaceutical Form
Velikost pakiranja
Duration of immunity: six months.
Trajanje imunosti: šest mesecev.
ATCvet code: QI09AB03.
Oznaka ATC vet: QI09AB03.
Onset of immunity: three weeks after completion of the basic vaccination scheme.
Nastop imunosti: tri tedne po zaključku osnovne sheme cepljenja.
LABORATORIOS HIPRA, S.A. Carretera C-63, km 48.300, Polígono Industrial El Rieral 17170 Amer (Gerona) SPAIN
LABORATORIOS HIPRA, S.A. Carretera C-63, km 48.300, Polígono Industrial El Rieral 17170 Amer (Gerona) ŠPANIJA
Pigs from 6 months of age which have not been previously vaccinated with the product should be given two injections with an interval of 3-4 weeks.
Pri prašičih, starih 6 mesecev ali več, ki še niso bili cepljeni s tem zdravilom, je treba dati dve injekciji z razmikom 3-4 tednov.
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 or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
SPC tabela 1 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.
Special warnings for each target species: Vaccinate only healthy animals.
Posebna opozorila za vsako ciljno živalsko vrsto: Cepite le zdrave živali.
For the active immunisation of male and female pigs to reduce clinical signs (skin lesions and fever) of swine erysipelas caused by Erysipelothrix rhusiopathiae, serotype 1 and serotype 2.
Za aktivno imunizacijo prašičjih samcev in samic za zmanjšanje kliničnih znakov (kožnih lezij in vročice) svinjske rdečice, ki jo povzroča bakterija Erysipelothrix rhusiopathiae, serotip 1 in serotip 2.
Administer one dose of 2 ml by intramuscular injection in the neck muscles according to the following schedule:
En 2-mililitrski odmerek aplicirajte z intramuskularno injekcijo v vratno mišičevje po naslednjem razporedu: Osnovno cepljenje:
Do not use in case of hypersensitivity to the active substance, to the adjuvants or to any of the excipients.
Ne uporabite v primerih preobčutljivosti na učinkovino, na dodatke ali na katero koli pomožno snov.
Marketing authorisation holder and manufacturer responsible for batch release: LABORATORIOS HIPRA, S.A.
Imetnik dovoljenja za promet z zdravilom in proizvajalec, odgovoren za sproščanje serij: LABORATORIOS HIPRA, S.A.
Store and transport refrigerated Do not freeze.
Shranjujte in prevažajte v hladilniku Ne zamrzujte.
To stimulate active immunisation against swine erysipelas.
Za stimulacijo aktivne imunizacije proti svinjski rdečici.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
V primeru nenamernega samo-injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino.
Date of first authorisation: 4/07/2014 Date of latest renewal:
Datum pridobitve dovoljenja za promet: 04/07/2014.
Store and transport refrigerated (2 ºC - 8 ºC).
Shranjujte in prevažajte pri temperaturi (2 °C - 8 °C).
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALCI BIOLOŠKIH UČINKOVIN IN PROIZVAJALCI ZDRAVILA, ODGOVORNI ZA SPROŠČANJE SERIJ
ERYSENG suspension for injection for pigs
ERYSENG suspenzija za injiciranje za prašiče
4.6 Adverse reactions (frequency and seriousness)
4.6 Neželeni učinki (pogostost in resnost) Zelo pogosti neželeni učinki:
Name and address of the manufacturers of the biological active substance
Ime in naslov proizvajalcev biološke učinkovine.
Special precautions for use in animals None.
Posebni previdnostni ukrepi za uporabo pri živalih Jih ni.
Cardboard box, (20 ml, 50 ml, 100ml, and 250ml) bottles (100 ml and 250 ml) and vials (100 ml)
KARTONSKA ŠKATLA, (20 ml, 50 ml, 100ml in 250ml) plastenke (100 ml, 250 ml) in viale (100 ml)
No adverse reactions other than those mentioned in section 4.6 were observed after the administration of a 2-fold vaccine dose.
Po dajanju dvojnega odmerka cepiva neželenih učinkov razen tistih, ki so navedeni v poglavju 4.6, ni bilo opaziti.
Pharmacotherapeutic group: Immunologicals for suidae, Inactivated bacterial vaccines, erysipelothrix.
Inaktivirana bakterijska cepiva, erysipelothrix.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND
PROIZVAJALCI BIOLOŠKE UČINKOVINE IN PROIZVAJALCI
Potassium chloride Potassium dihydrogen phosphate Simethicone
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi aluminijev hidroksid DEAE-dekstran dinatrijev fosfat dodekahidrat korenina pravega ženšena (ginsenga) kalijev klorid kalijev dihidrogen fosfat simetikon natrijev klorid natrijev hidroksid voda za injekcije
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovina biološkega izvora namenjena vzbujanju aktivne imunosti, ne spada v področje uporabe
No adverse reactions other than already mentioned under section “Adverse reactions” can be expected after the administration of a 2-fold vaccine dose.
Po dajanju dvojnega odmerka cepiva neželeni učinki razen tistih, ki so navedeni v poglavju »Neželeni učinki«, niso pričakovani.
Very rare adverse reactions: - Anaphylactic-type reactions have been reported in spontaneous reports and appropriate symptomatic treatment is recommended.
- Spontano se poročali o primerih reakcij anafilaktičnega tipa.
Inactivated Erysipelothrix rhusiopathiae, strain R32E11, ....................... ELISA > 3.34 log2 IE50 %* * IE50% - Inhibition ELISA 50%.
inaktivirana bakterija Erysipelothrix rhusiopathiae, sev R32E11 .. ELISA > 3,34 log2 IE50 % * * IE50 % - inhibicija ELISA 50%