natgillin/translations-raw huggingface dataset:
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals ) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (pojavijo se pri več kot 1 živali od 10 živali med enim zdravljenjem) - pogosti (pojavijo se pri več kot 1 toda manj kot pri 10 živalih od 100 živali) - občasni (pojavijo se pri več kot 1 toda manj kot pri 10 živalih od 1.000 živali) - redki (pojavijo se pri več kot 1 toda manj kot pri 10 živalih od 10.000 živali) - zelo redki (pojavijo se pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere).
No effect other than those already mentioned in section 4.6 “Adverse reactions” have been observed, except hyperthermia that may exceptionally last 5 days.
Drugi učinki, razen tistih, ki so navedeni v poglavju 4.6 »Neželeni učinki«, niso znani, razen povišane temperature , ki izjemoma lahko traja pet dni.
1 cell culture infective dose 50%
1 50% infektivni odmerek za celično kulturo
* less than 1 animal in 10,000 animals displaying adverse reaction(s) during the course of one treatment, including isolated reports.
* manj kot 1 živali od 10.000 živali kaže neželene učinke med trajanjem enega zdravljenja, vključujoč posamezne primere
EU/2/04/050/001 Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) EU/2/04/050/002 Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
EU/2/04/050/001 Liofilizat (10 stekleničk z 1 odmerkom) in vehikel (10 stekleničk po 1 ml) EU/2/04/050/002 Liofilizat (50 stekleničk z 1 odmerkom) in vehikel (50 stekleničk po 1 ml)
Revaccination: - the first revaccination must be carried out for all components one year after the primary vaccination course, - subsequent revaccinations must be carried out: every year for the chlamydiosis component and at intervals of up to three years for the rhinotracheitis, calicivirosis and panleucopenia components.
Ponovno cepljenje: - prvo ponovno cepljenje je potrebno opraviti za vse komponente eno leto po osnovnem cepljenju, - nadaljnja ponovna cepljenja je potrebno opraviti: vsako leto za komponento klamidioze in v obdobjih do 3 leta za komponente rinotraheitisa, kaliciviroze in panleukopenije.
2 egg infective dose 50%
2 50% infektivni odmerek za embrionirana kokošja jajca
Type I glass bottle containing 1 dose of lyophilisate and type I glass bottle containing 1 ml solvent, both closed with a butyl elastomer closure and sealed with an aluminium or plastic cap.
Prebodna steklenička iz stekla tipa 1, ki vsebuje 1 odmerek liofilizata, in prebodna steklenička iz stekla tipa I, ki vsebuje vehikel; obe zaprti z gumijastim zamaškom in zaščiteni z aluminijasto ali plastično zaporko.
The product was shown to reduce excretion of feline calicivirus at onset of immunity and for one year after vaccination.
Cepivo dokazano zmanjša izločanje kalici virusa mačk ob nastopu imunosti in do 1 leto po cepljenju.
Lyophilisate (10xdose) + solvent (10x1 ml) Lyophilisate (50x1 dose) + solvent (50x1 ml)
Liofilizat (10 x 1 odmerek) in vehikel (10 x 1 ml) Liofilizat (50 x 1 odmerek) in vehikel (50 x 1 ml)
Active immunisation of cats aged 8 weeks and older: - against feline viral rhinotracheitis to reduce clinical signs, - against calicivirus infection to reduce clinical signs, - against Chlamydophila felis infection to reduce clinical signs, - against feline panleucopenia to prevent mortality and clinical signs.
Aktivna imunizacija 8 tednov starih mačk in starejših: - proti kužnemu rinotraheitisu mačk, za ublažitev kliničnih znamenj, - proti okužbam s kalicivirusi, za ublažitev kliničnih znamenj,
The duration of immunity after the last re-vaccination is 3 years for the rhinotracheitis, calicivirosis and panleucopenia components, and 1 year for the Chlamydophila felis component.
Trajanje imunosti je 3 leta po zadnjem ponovnem cepljenju za komponente kužnega rinotraheitisa, kaliciviroze in panleukopenije, ter 1 leto za komponento Chlamydophila felis.
Stimulates active immunity against feline rhinotracheitis herpesvirus, feline calicivirus, Chlamydophila felis and feline panleucopenia virus.
Vzpodbuja aktivno imunost proti herpesvirusu kužnega rinotraheitisa, kalicivirusu, Chlamydophila felis, ter virusu panleukopenije.
PACKAGE LEAFLET FOR: Purevax RCPCh lyophilisate and solvent for suspension for injection
NAVODILO ZA UPORABO ZA: Purevax RCPCh liofilizat in vehikel za suspenzijo za injiciranje
Purevax RCPCh lyophilisate and solvent for suspension for injection
Purevax RCPCh Liofilizat in vehikel za suspenzijo za injiciranje
Where high levels of maternal antibodies against rhinotracheitis, calicivirosis, panleucopenia or Chlamydophila components are expected to be present (e.g. in kittens of 9-12 weeks of age born from queens which were vaccinated before pregnancy and/or with known or suspected previous exposure to the pathogen(s)), the primary vaccination course should be delayed until 12 weeks of age.
Kjer je pričakovati visoke titre maternalnih protiteles proti komponentam rinotraheitisa, kaliciviroze, panleukopenije ali Chlamydophile (na primer pri mladičih starih od 9 do 12 tednov, rojenih mačkam,
Vaccine against feline viral rhinotracheitis, feline calicivirosis, chlamydiosis and feline panleucopenia.
Cepivo proti virusnemu rinotraheitisu, kalicivirusu, klamidiozi in panleukopeniji.
Purevax RCPCh Lyophilisate and solvent for suspension for injection.
Purevax RCPCh liofilizat in vehikel za suspenzijo za injiciranje
Where high levels of maternal antibodies against rhinotracheitis, calicivirosis, panleucopenia or Chlamydophila components are expected to be present (e.g. in kittens of 9-12 weeks of age borne from queens which were vaccinated before pregnancy and/or with known or suspected previous exposure to the pathogen(s)), the primary vaccination course should be delayed until 12 weeks of age.
ki so bile cepljene pred brejostjo in/ali je znano ali verjetno, da so bile predhodno izpostavljene patogenu (om)), je potrebno osnovno cepljenje odložiti do starosti 12 tednov.
Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ....................................... ≥ 104.9 CCID501 Inactivated feline calicivirus (FCV 431 and FCV G1 strains) antigens .......................... ≥ 2.0 ELISA U. Attenuated Chlamydophila felis (905 strain) ...................................................................... ≥ 103.0 EID502 Attenuated feline panleucopenia virus (PLI IV) ............................................................. ≥ 103.5 CCID501
Zdravilne učinkovine: Atenuirani herpes virus rinotraheitisa mačk (sev FHV F2) ............................................. ≥ 104,9 CCID501
Per dose of 1 ml: FHV (F2 strain) ................................................................................................................. ≥ 104.9 CCID50
Atenuirani herpes virus rinotraheitisa mačk (sev FHV F2) ............................................. ≥ 104,9 CCID501
Gentamicin, at most .......................................................................................................................... 28 µg Solvent:
Gentamicin, največ ........................................................................................................................... 28 µg
There was no toxic effect.
Toksičnega učinka ni bilo.
However, the same EFSA document also states that:
V istem dokumentu agencije EFSA je navedeno tudi:
Therefore this indication was removed.
Zato je bila ta indikacija odstranjena.
Lilly Portugal Produtos
Portugalska Lilly Portugal Produtos
A disease shall be included on the list if it has been assessed in accordance with Article 7.
Bolezen bo vključena na seznam, če je že bila ocenjena v skladu s členom 7.
The study was conducted under the principles of Good Clinical Practice.
Študija je bila opravljena v skladu z načeli dobre klinične prakse.
Average daily water intake (l/animal)
Povprečni dnevni vnos vode (l/žival)
• The restriction of the indications to those that are adequately substantiated by efficacy data;
• zaradi omejitve indikacij na tiste, ki so ustrezno utemeljene s podatki o učinkovitosti;
This is stated in the Regulation (EC) No 2160/20039 and based on the EFSA Opinion (2004)11.
To je navedeno v Uredbi (ES) št. 2160/20039 in temelji na mnenju agencije EFSA (2004)11.
in poultry has little justification.
pri perutnini le šibko utemeljena.
National control programmes should be followed where available.‘
Upoštevati je treba nacionalne programe nadzora, kadar so ti na voljo.“
MIC90 was 8 μg/ml or less.
MIK90 je bila 8 μg/ml ali manj.
Those measures may cover, for example, prohibitions and restrictions on the use of veterinary medicinal products.
Ti ukrepi lahko na primer vključujejo prepovedi in omejitve uporabe zdravil za uporabo v veterinarski medicini.
and Campylobacter spp.
in Campylobacter spp.
Additionally, the shelf life has been reduced to 18 months.
Poleg tega je bil rok uporabnosti skrajšan na 18 mesecev.
Therefore, the CVMP concluded that the proposed indication was justified.
Zato je odbor CVMP zaključil, da je predlagana indikacija utemeljena.
ATCvet code: QA07AA92.
Oznaka ATC vet: QA07AA92.
Absorption: Absorption may be high in new-born animals but rapidly decreases in the first weeks of life.
Absorpcija: Absorpcija pri novorojenih živalih je lahko velika, vendar se v prvih tednih življenja hitro zmanjšuje.
Swelling of the face, lips and eyes or difficult breathing are more serious symptoms and require urgent medical assistance.
Otekanje obraza, ustnic in oči ali težave z dihanjem so resnejši simptomi, ki zahtevajo nujno zdravniško pomoč.
Mortality was the principal criteria for efficacy.
Glavno merilo učinkovitosti je bila umrljivost.
This evaluation focuses on issues with regard to the harmonisation that may change the benefit-risk balance.
Ta ocena se osredotoča na vprašanja v zvezi z usklajevanjem, ki lahko spremenijo razmerje med koristmi in tveganjem.
Any use in exceptional circumstances on animal health and welfare grounds must recognize the consequences for public health.
Vsakršna uporaba v izjemnih okoliščinah zaradi živalskega zdravja in dobrega počutja mora upoštevati posledice za javno zdravje.
Medicated water must be renewed every 24 hours.
Vodo z dodanim zdravilom je treba zamenjati vsakih 24 ur.
Animals with acute or severe clinical conditions that cannot drink, should receive adequate parenteral treatment.
Živali z akutnim ali resnim kliničnim stanjem, ki ne morejo piti, morajo prejeti ustrezno parenteralno zdravljenje.
The scope of the re-examination was the shelf life of the product prior to first opening which was reduced from 3 years to 18 months.
Obseg ponovnega pregleda je bil rok uporabnosti zdravila pred prvim odprtjem, ki se je skrajšal s treh let na 18 mesecev.
Following the CVMP opinion of 5 October 2017 on this referral procedure, the marketing authorisation holders requested a re-examination of the CVMP opinion.
Na podlagi mnenja odbora CVMP z dne 5. oktobra 2017 o tem napotitvenem postopku so imetniki dovoljenj za promet z zdravilom zahtevali ponovni pregled mnenja odbora CVMP.
If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.
Če to ni mogoče, mora zdravljenje temeljiti na lokalnih (regionalnih, na ravni kmetije) epidemioloških informacijah o občutljivosti ciljnih bakterij.
The harmonisation of withdrawal periods was based on the better conducted and most reliable studies.
Uskladitev karenc je temeljila na bolje izvedenih in najzanesljivejših študijah.
Solutions in milk and reconstituted milk replacer should be prepared immediately before use.
Raztopine v mleku in rekonstituiranem mlečnem nadomestku je treba pripraviti tik pred uporabo.
Furthermore, in this sense, the European Commission shall adopt delegated acts in accordance with Article 264 concerning amendments to the list referred.
Nadalje bo v tem smislu Evropska komisija sprejela delegirane akte v skladu s členom 264 v zvezi s spremembami in dopolnitvami zadevnega seznama.
Drinking systems should be clean and free of rust to avoid reduction of activity.
Sistemi za napajanje morajo biti čisti in nezarjaveli, da se aktivnost ne zmanjša.
National control programmes should be followed where available.
Treba je upoštevati nacionalne programe nadzora, kjer so na voljo.
• The harmonised product information of Girolan contains the necessary information to ensure the safe and effective use of the product.
• ker usklajene informacije o zdravilu Girolan vsebujejo potrebne informacije za zagotavljanje varne in učinkovite uporabe zdravila.
The amount of product (mg) to be incorporated per 1 l of water or milk should be established according to the following formula:
Količina zdravila (mg), ki jo je treba dodati 1 litru vode ali mleka, se določi po naslednji formuli:
The potential risk of resistance development, which might impact product efficacy, and overall animal and human health, is limited through:
Tveganje za razvoj odpornosti, ki bi lahko vplivalo na učinkovitost zdravila in splošno zdravje živali in ljudi, je omejeno:
A pivotal recently-conducted clinical field trial was provided.
Predložili so nedavno opravljeno ključno klinično terensko preskušanje.
Furthermore, the European Commission shall adopt delegated acts concerning amendments to the list referred.
Nadalje bo Evropska komisija sprejela delegirane akte v zvezi s spremembami in dopolnitvami zadevnega seznama.
All calves were subjected to a full clinical examination daily for at least the first week of each trial.
Vsa teleta so vsaj prvi teden vsakega preskušanja vsak dan celovito klinično pregledali.
Whenever possible, susceptibility testing and serotyping of bacterial isolates were carried out.
Kadar je bilo mogoče, so opravili teste občutljivosti in serotipizacijo bakterijskih izolatov.
In this respect, it is to be noted that colibacillosis in chickens is essentially a systemic infection, involving a variety of organs, and its main entry route is the respiratory system.
V zvezi s tem je treba opozoriti, da je kolibaciloza pri piščancih predvsem sistemska okužba, ki vključuje različne organe, glavna pot vstopa pa so dihala.
All studies have been performed with the maximal dose proposed in the product information.
Vse študije so bile opravljene z največjim odmerkom, predlaganim v informacijah o zdravilu.
This lack of storage precautions for the product is based on historical data, and was already approved in the individual Member States prior to the referral.
Odsotnost navodil za shranjevanje zdravila temelji na starih podatkih in je bila v posameznih državah članicah odobrena že pred napotitvijo.
Sachets are packed in cardboard boxes containing 50 sachets.
Vrečke so zapakirane v kartonske škatle, ki vsebujejo 50 vrečk.
The treatment period was initiated two weeks after weaning, when the signs of colibacillosis were clearly established.
Obdobje zdravljenja se je začelo dva tedna po odstavitvi, ko so bili znaki kolibaciloze jasno ugotovljeni.
Once opened, use within 28 days.
Odprto uporabite v 28 dneh.
In this sense, it should be taken into account that the efficacy of the product was supported by various studies, where the veterinary medicinal product was administered for treatment and not for prevention.
V tem smislu je treba upoštevati, da učinkovitost zdravila podpirajo različne študije, pri katerih je bilo zdravilo namenjeno zdravljenju in ne preprečevanju.
According to the assessment performed, Salmonella can be considered eligible to be listed for Union intervention as laid down in Article 5(3) of the Animal Health Law.
Glede na izvedeno oceno velja bakterija Salmonella kot primerna za uvrstitev na seznam ukrepov Unije, kot določa člen 5(3) pravil o zdravju živali.
With regard to Salmonella, a series of twenty-seven further experiments were conducted in calves, 15 of which therapeutic and 12 prophylactic.
Kar zadeva bakterijo Salmonella, so pri teletih opravili nadaljnjih 27 poskusov, od katerih je bilo 15 terapevtskih in 12 profilaktičnih.
• No specific advantages were identified for the use of antimicrobials in the case of meat-producing flocks.
• Konkretnih prednosti uporabe protimikrobnih zdravil pri jatah za proizvodnjo mesa niso ugotovili.
Thus the data provided includes a sufficient number of batches in each of the container types for the full duration of the proposed shelf life.
Predloženi podatki torej vključujejo zadostno število serij za vsako vrsto vsebnika za celotno trajanje predlaganega roka uporabnosti.
Although it is acknowledged that Salmonella Dublin is an uncommon cause of salmonellosis in man, infection can be severe.
Čeprav se priznava, da Salmonella Dublin ni pogost vzrok salmoneloze pri človeku, je okužba lahko resna.
Data for 36 months was presented for 3 batches of finished product packaged in the final containers (bottles, bags and two different size sachets).
Podatki za 36 mesecev so bili predloženi za tri serije končnega zdravila, zapakiranega v končne vsebnike (plastenke, vrečke in vrečice dveh velikosti).
This benefit-risk evaluation is performed in the context of Article 34 of Directive 2001/82/EC, which in the present procedure has the purpose of obtaining harmonisation within the EU of the conditions of authorisation for the veterinary medicinal product Girolan.
Ta ocena razmerja med tveganji in koristmi je bila opravljena v okviru člena 34 Direktive 2001/82/ES, ki je v tem postopku namenjen uskladitvi pogojev za izdajo dovoljenja za zdravilo Girolan za uporabo veterinarski medicini v EU.
These were conducted in Greece, Italy and Jordan, and involved 27-29 days old broilers from commercial farms with natural E. coli infection.
Preskušanja so izvajali v Grčiji, Italiji in Jordaniji, vključevala pa so 27-29 dni stare pitovne piščance iz komercialnih kmetij, naravno okužene z E. coli.
In addition use of apramycin was considered preferable to the potential use of more critical antimicrobials such as fluoroquinolones.
Poleg tega so presodili, da je uporaba apramicina boljša kot morebitna uporaba bolj kritičnih protimikrobnih zdravil, kot so fluorokinoloni.
Germany Lilly Deutschland GmbH
Lilly Deutschland GmbH
These data are consistent with the published literature.
Ti podatki so skladni z objavljeno literaturo.
Although the respiratory route is considered a significant mode of entry, antimicrobials are expected to act at the site of infection.
Čeprav pot prek dihal velja za pomemben način vstopa, naj bi protimikrobna zdravila delovala na mestu okužbe.
The main animal species to be listed are all species of domestic poultry and wild species of mainly Anseriformes and Galliformes.
Glavne živalske vrste, ki bodo uvrščene, so vse vrste domače perutnine in divje vrste, predvsem vrste plojkokljunov in kur.
Zoonotic Salmonella is listed in this Regulation.
V tej uredbi je navedena tudi zoonotska Salmonella.
Once opened, use immediately.
Odprto uporabite takoj.
No accelerated data have been provided during the referral procedure.
Med napotitvenim postopkom ni bilo predloženih podatkov o pospešenih testih.
It should be noted that in some Member States Girolan was also authorised for use against Salmonella in pigs, however the marketing authorisation holder decided to remove this indication, as it could not be supported.
Treba je opozoriti, da je bilo zdravilo Girolan v nekaterih državah članicah pri prašičih odobreno tudi za uporabo proti bakteriji Salmonella, vendar se je imetnik dovoljenja za promet z zdravilom odločil, da bo to indikacijo odstranil, saj je ni bilo mogoče podpreti.
In all trials, the animals were examined to confirm the diagnosis prior of to the initiation of treatment.
V vseh preskušanjih so živali pred začetkom zdravljenja pregledali in potrdili diagnozo.
From the study it could be concluded that Salmonella Pullorum infections could be controlled with apramycin.
Iz študije je mogoče zaključiti, da se okužbe z bakterijo Salmonella Pullorum lahko nadzorujejo z apramicinom.
The testing timepoints for these batches are not all in accordance with current guidelines but in all cases, data is provided for at last 5 time-points over the course of the stability study and trending of data is therefore possible.
Časovne točke testiranja teh serij niso bile vse v skladu s trenutnimi smernicami, vendar so bili v vsakem primeru predloženi podatki za vsaj pet časovnih točk v obdobju študije stabilnosti, zato je mogoče ugotavljanje spreminjanja podatkov.
All references to ‘g of apramycin activity' or measuring devices have been removed from the product information.
Vse navedbe „gramov apramicinske dejavnosti“ ali merilnih pripomočkov so bile odstranjene iz informacij o zdravilu.
On 24 June 2016 Spain submitted a referral notification in accordance with Article 34 of Directive 2001/82/EC to the European Medicines Agency (the Agency) for Girolan and its associated name Apralan.
Španija je 24. junija 2016 Evropski agenciji za zdravila (agenciji) v skladu s členom 34 Direktive 2001/82/ES predložila obvestilo o napotitvi za zdravilo Girolan in povezano ime Apralan.
However, no storage conditions are provided for these stability studies and it is therefore not clear if they have been conducted at 25 °C/60% RH in accordance with the requirements of the ‘Guideline on stability testing of existing active substances and related finished products (EMEA/CVMP/846/99-Rev.1)'15.
Vendar pa za te študije stabilnosti niso predložili pogojev shranjevanja in zato ni jasno, ali so bile opravljene pri 25 °C/60% relativne vlažnosti, v skladu z zahtevami „Smernic o preskušanju stabilnosti obstoječih zdravilnih učinkovin in povezanih končnih zdravil (EMEA/CVMP/846/99-Rev.1)“15.
This was also not considered acceptable, as dosing by product weight was considered the most appropriate in terms of reproducibility of the dose and therefore any reference to the measuring device was deleted from the product information.
To prav tako ni bilo ocenjeno kot sprejemljivo, saj odmerjanje po teži zdravila velja za najprimernejšega v smislu ponovljivosti odmerka, zato so bile vse navedbe merilnega pripomočka izbrisane iz informacij o zdravilu.
Medicated water should be the only source of drinking.
Voda z dodanim zdravilom mora biti edini pitni vir.
Overall summary of the scientific evaluation of Girolan and its associated name Apralan (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravila Girolan in povezanega imena Apralan (glejte Prilogo I)
The results obtained showed statistically significant difference on mortality between all the apramycin medicated groups and the unmedicated control groups.
Dobljeni rezultati so pokazali statistično značilno razliko v umrljivosti med skupinami, zdravljenimi z apramicinom, in nezdravljenimi kontrolnimi skupinami.
CVMP overall conclusions after re-examination
Končni zaključki odbora CVMP po ponovnem pregledu
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Pigs: Pigs have been given up to nine times the recommended use level in their drinking water for 28 days with no untoward reaction.
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi), (če je potrebno) Prašiči: prašiči so z vodo za pitje 28 dni prejemali do devetkrat večji odmerek od priporočenega, ne da bi se pojavile neželene reakcije.
as well as resistant commensal bacteria, which may also transfer resistance genes to other bacteria.
ter odpornimi komenzalnimi bakterijami, ki gene za odpornost lahko prenesejo tudi na druge bakterije.
The assay results are presented as % of a target value of 552,000 IU/g.
Rezultate testov so predložili v obliki % ciljne vrednosti 552 000 i.e./g.