natgillin/translations-raw huggingface dataset:
CVMP have noted the inconsistencies (with regard to extraneous agents testing) in the Ph. Eur. monographs for inactivated bovine vaccines and have written to the EDQM and asked them to address this.
Odbor CVMP je ugotovil neskladnosti (pri testiranju na prisotnost tujih snovi) v monografijah evropske farmakopeje v primeru neaktiviranih cepiv za govedo, o katerih je EDQM (Evropskemu direktoratu za kakovost zdravil) podal pisno prošnjo za odgovor na vprašanje.
The CVMP has concluded that the risk/ benefit for Bovilis BVD is favourable.
CVMP je zaključil, da je razmerje med koristmi in tveganji za zdravilo Bovilis BVD ugodno.
10/ 12 ANNEX III
10/ 12 DODATEK III
SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE INSERT
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJE IN NAVODILO ZA UPORABO
11/ 12 The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
11/ 12 Veljavni Povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so zadnje različice, ki so bile pripravljene v postopku koordinacijske skupine.
London, June 2008 EMEA/ 532090/ 2007– Rev.1
London, junij 2008 EMEA/ 532090/ 2007 – Rev. 1
OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR BOVILIS BVD/ BOVILIS BVD-MD
MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 33( 4) ZA ZDRAVILO BOVILIS BVD/ BOVILIS BVD- MD
Bovilis BVD/ Bovilis BVD-MD is an inactivated virus vaccine containing the inactivated antigen of cytopathic BVD virus strain C-86.
Zdravilo Bovilis BVD/ Bovilis BVD- MD je cepivo z inaktiviranim virusom, ki vsebuje inaktiviran antigen virusnega seva citopatske goveje virusne diareje (GVD) C- 86.
Bovilis BVD was first authorised in Germany as Bovilis BVD-MD.
Zdravilo Bovilis BVD je dovoljenje za promet najprej pridobilo v Nemčiji kot Bovilis BVD- MD.
Denmark could not agree with the granting of the marketing authorisation and the matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures, CMD(v) and subsequently the Committee for Medicinal Products for Veterinary Use (CVMP).
Danska se z odobritvijo dovoljenja za promet z zdravilom ni mogla strinjati in zadevo napotila na Koordinacijsko skupino za medsebojno priznavanje in decentralizirane postopke (CMD( v)) in naknadno na Odbor za zdravila za uporabo v veterinarski medicini (CVMP).
Denmark considered that the proposed testing regime to demonstrate freedom from extraneous agents was insufficient to ensure that Bovilis BVD/ Bovilis BVD-MD would not interfere with their national eradication campaigns for certain animal diseases and that, therefore, the benefit/ risk assessment for Bovilis BVD/ Bovilis BVD-MD was unfavourable, authorisation of the product representing a potential serious risk to animal health.
Danska je menila, da predlagani režim testiranja za predstavitev odsotnosti tujih snovi v zadostni meri ne zagotavlja, da zdravilo Bovilis BVD/ Bovilis BVD- MD ne bi oviralo nacionalnih programov za izkoreninjenje določenih bolezni živali ter da razmerje med koristmi in tveganji za zdravilo Bovilis BVD/ Bovilis BVD- MD ni ugodno, tako da bi morebitna odobritev dovoljenja za promet z zdravilom lahko pomenila možno resno tveganje za zdravje živali.
During its meeting of November 2006, the CVMP started a referral procedure under Article 33(4) of Directive 2001/ 82/ EC as amended for Bovilis BVD/ Bovilis BVD-MD.
Odbor za zdravila za uporabo v veterinarski medicini je na zasedanju novembra 2006 sprožil napotitveni postopek v skladu s členom 33( 4) Direktive 2001/ 82/ ES, kakor je bila spremenjena, za zdravilo Bovilis BVD/ Bovilis BVD- MD.
The Marketing Authorisation Holder was requested to provide all supporting data to justify a positive benefit-risk ratio for the treated animal.
Imetnik dovoljenja za promet je bil naprošen za predložitev vseh podpornih podatkov, ki bi upravičili pozitivno razmerje med koristmi in tveganji za zdravljenje živali.
Extraneous agents testing of batches of finished product, if required.
Odbor za zdravila za uporabo v veterinarski medicini je menil, da se lahko na splošno odsotnost tujih snovi pri cepivih lahko zagotovi z:
The production and testing of Bovilis BVD vaccine are in accordance with the relevant requirements of Directive 2001/ 82/ EC, the relevant EU guidelines and the relevant monographs of the Ph. Eur.
1. upoštevanjem dobre proizvodne prakse v proizvodnem sistemu 2. testiranje surovin na tuje snovi 3. po potrebi testiranjem serij končnega zdravila na tuje snovi.
CVMP have noted the inconsistencies (with regard to extraneous agents testing) in the Ph. Eur. monographs for inactivated bovine vaccines and have written to the EDQM and asked them to address this.
Odbor za zdravila za uporabo v veterinarski medicini je opazil neskladnosti (v zvezi s testiranji na tuje snovi) v monografijah Evropske farmakopeje za inaktivirana cepiva za govedo in za obravnavanje tega vprašanja pisno zaprosil Evropsko direkcijo za kakovost zdravil (EDQM).
EMEA/ 532090/ 2007-Rev.1
EMEA/ 532090/ 2007- Rev. 1- SL
London, August 2008 EMEA/ 459391/ 2008
London, avgust 2008 EMEA/ 459391/ 2008
OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR COMPAGEL GEL FOR HORSES
MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 33( 4) ZA ZDRAVILO COMPAGEL GEL ZA KONJE
The gel is applied on the skin and its indications are: • Haematoma, tendinitis, tendovaginitis, bursitis, capped hock, saddle sore, sprain, torsion, contusion, bruising, inflammation of the joint capsule (synovitis), muscle rupture, after nerve block anaesthesia, after paravenous injection. • To accelerate the absorption of infiltrates (e. g. postoperative swelling, penile paralysis). • To treat inflammations of superficial veins (e. g. phlebitis, thrombophlebitis, infusion thrombophlebitis).
Gel se nanaša na kožo, njegove indikacije pa so: • hematom, vnetje kit (tendinitis), vnetje kitne ovojnice (tendovaginitis), vnetje sluzne vrečice (burzitis), vnetje podkolenice, vnetja zaradi sedla, zvini, torzije, poškodbe, mehanske poškodbe, vnetje sklepnih kapsul (sinovitis), natrgane mišice, po anesteziji z živčno blokado, po paravenoznem injiciranju; • za pospešitev absorpcije infiltratov (npr. pooperativno otekanje, paraliza penisa); • zdravljenje vnetja površinskih ven (npr. flebitis, tromboflebitis, infundirajoči tromboflebitis).
The matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures CMD(v) and subsequently to the CVMP.
Zadeva je bila napotena na Usklajevalno skupino za postopek medsebojnega priznavanja in decentralizirani postopek (CMD( v)) ter naknadno na Odbor za zdravila za uporabo v veterinarski medicini (CVMP).
Under these conditions the applicant is exempted from submitting further preclinical or clinical data on efficacy of the 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
V skladu s temi pogoji 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. proposed product and can claim the same indications for use as for the reference product.
Reproduction is authorised provided the source is acknowledged. predlagatelju ni treba predložiti nadaljnjih predkliničnih ali kliničnih podatkov o učinkovitosti predlaganega zdravila in lahko zahteva iste indikacije za uporabo kot za referenčno zdravilo.
EMEA/ 459391/ 2008-EN
EMEA/ 459391/ 2008- SL
NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER
IME, FARMACEVTSKA OBLIKA, JAKOST ZDRAVILA, ŽIVALSKE VRSTE, POTI UPORABE ZDRAVILA IN IMETNIKI DOVOLJENJA ZA PROMET
1/ 7 Applicant or Marketing Authorisation Holder
1/ 7 Predlagatelj ali
Product invented name
Živalska vrsta
Pharmaceutical form
Priporočeni odmerek
Strength
ime izdelka
Animal species
Boehringer In
Frequency and route of administration
gelheim Compagel gel
Recommended dose
100 g gela vsebuje:
Boehringer Ingelheim Vetmedica GmbH Binger Str.
Vetmedica GmbH Binger Str.
173 55216 Ingelheim Germany
173 55216 Ingelheim Nemčija
gel
gel za konje
100g gel contains: heparin sodium 50 000 IU levomenthol 0.5 g hydroxyethyl salicylate 5.0 g
heparin natrij 50. 000 i. e. levomentol 0, 5 g hidroksietilsalicilat 5, 0 g
Up to a total daily quantity of 50 g gel per day is applied using finger tip pressure onto the affected area according to the veterinary surgeon’ s instructions until signs and symptoms resolve.
veterinarja s pritiskom prstov nanašamo do skupne dnevne količine 50 g gela, dokler znaki in simptomi ne izzvenijo.
After nerve block anaesthesia the gel should be applied to the skin in a layer the thickness of the back of a knife and covered with a bandage.
Gel nanesemo na kožo po anesteziji z blokado živcev v sloju, debelem za rezilo noža, in prekrijemo s povojem.
2/ 7 ANNEX II
2/ 7 DODATEK II
3/ 7 SCIENTIFIC CONCLUSIONS
3/ 7 ZNANSTVENI ZAKLJUČKI
Germany, reference member state in the decentralised procedure, notified the EMEA on 21 December 2008 that the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMD(v)) failed to reach an agreement for Compagel gel for horses.
Nemčija, referenčna država članica v decentraliziranem postopku, je 21. decembra 2007 obvestila EMEA, da v Koordinacijski skupini za postopke medsebojnega priznavanja in decentralizirane postopke – zdravila za veterinarsko uporabo (CMD( v)) ni bilo doseženo soglasje o zdravilu Compagel gel za konje.
Pursuant to Article 33(4) of Council Directive 2001/ 82/ EC, as amended, the matter was referred to the CVMP.
Zadeva je bila skladno s členom 33( 4) Direktive Sveta 2001/ 82/ ES, kakor je bila spremenjena, napotena na Odbor za zdravila za uporabo v veterinarski medicini (CVMP).
France and Sweden consider that due to the absence of efficacy documentation it cannot be assumed that the product is efficacious and that this as such presents a potential serious risk to animal health.
Francija in Švedska menita, da zaradi pomanjkanja dokumentacije o učinkovitosti ni možno domnevati, da je zdravilo učinkovito, in zaradi tega predstavlja možno resno tveganje za zdravje živali.
CVMP noted that Compagel gel for horses is a generic of Tensolvet 50000 (authorised in Germany) and that the concerns raised by France and Sweden can only be addressed in the framework of this procedure, in case any differences between the two products would justify different conclusions on the safety or efficacy.
CVMP je opozoril, da je zdravilo Compagel gel za konje generična različica zdravila Tensolvet 50000 (ki je odobreno v Nemčiji) in da se lahko zadržki Francije in Švedske obravnavajo le v okviru tega postopka, če bi se ugotovilo, da razlike med zdraviloma omogočajo različne zaključke o varnosti in učinkovitosti.
CVMP started the procedure on 16 January 2008.
CVMP je pričel z napotitvenim postopkom 16. januarja 2008.
A list of questions was adopted the same day and sent to the applicant, by which the procedure clock was stopped.
Isti dan je bil sprejet seznam vprašanj, ki je bil poslan predlagatelju, s čimer se je postopkovna ura ustavila.
On 22 January 2008 responses to the questions were received from applicant and the clock restarted.
Odbor je 22. januarja 2008 od predlagatelja prejel odgovore na vprašanja in ponastavil uro.
The aim of the assessment is to establish whether marketing authorisations of veterinary medicinal products included in the referral procedure should be maintained, suspended, varied or revoked with view to the grounds for referral.
Cilj vrednotenja je ugotoviti, ali naj se dovoljenja za promet z zdraviloma za uporabo v veterinarski medicini, ki sta vključena v napotitvenem postopku, obdržijo, zadržijo, spremenijo ali prekličejo glede na vzroke za ta postopek.
A copy of the information and documents referred to in the first subparagraph of Article 32(1) of the Directive and any additional information provided to the Reference Member State during the 60 day CMD(v) procedure (rapporteurs and EMEA only).
Kopijo podatkov in dokumentov, na katere se nanaša prvi pododstavek člena 32( 1) Direktive, in vse dodatne podatke, ki so bili predloženi referenčni državi do vključno 60. dne postopka CMD( v) (samo poročevalci in EMEA).
In view of the concerns raised by France and Sweden, to indicate and to substantiate where necessary, any differences between Compagel gel for horses and reference product Tensolvet 50000 (authorised in Germany) that could justify different conclusions on the efficacy for the two products.
Zaradi zadržkov Francije in Švedske prikazati in po potrebi utemeljiti vse razlike med zdravilom Compagel gel za konje in referenčnim zdravilom Tensolvet 50000 (ki je odobreno v Nemčiji), ki bi lahko upravičile različne zaključke o učinkovitosti zdravil.
In response to question 1, the applicant provided a copy of the original dossier as submitted in support of the application of a mutual recognition procedure, and any supplementary data submitted during the mutual recognition procedure and the referral procedure in CMD(v) thereafter.
V zvezi s 1. vprašanjem je predlagatelj predložil kopijo izvirne dokumentacije, ki je bila predložena kot utemeljitev vloge za postopek medsebojnega priznavanja, in vse dodatne podatke, ki so bili predloženi med postopkom medsebojnega priznavanja ter med napotitvenem postopkom v CMD( v).
13 of Directive 2001/ 82/ EC as amended, in which it is stated that “ By way of derogation from point (j) of the first subparagraph of Article 12 (3), and without prejudice to the law relating to the protection of industrial and commercial property, the applicant shall not be required to provide the results of the safety and residue tests or of the preclinical and clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorized under Article 5 for not less than eight years in a Member State or the Community .”
Vloga za Compagel gel za konje je temeljila na členu 13 Direktive 2001/ 82/ ES, kakor je bila spremenjena, ki določa, da „ Z odstopanjem od točke (j) prvega pododstavka člena 12( 3) ter brez poseganja v zakonodajo, ki se nanaša na varovanje industrijske in komercialne lastnine: predlagatelju ni treba predložiti rezultatov varnostnih in farmakoloških preskusov ter predkliničnih in kliničnih preskušanj, v primeru, če lahko dokaže, da je zdravilo generična različica referenčnega zdravila, ki je ali je bilo v državi članici ali Skupnosti odobreno po členu 5 najmanj osem let. “
Reference is made to the reference product Tensolvet 50000 which has been registered and used over a period of more than eight years in Germany.
Sklicuje se na referenčno zdravilo Tensolvet 50000, ki je bilo registrirano v Nemčiji in se v Nemčiji uporablja dlje kot 8 let.
All concerned member states in the mutual recognition procedure agreed that Compagel gel for horses is essentially similar to Tensolvet 50000.
Vse zadevne države članice v postopku medsebojnega priznavanja soglašajo, da je Compagel gel za konje bistveno podoben zdravilu Tensolvet 50000.
In response to question 2, the applicant responded that there are no differences at all that would justify different conclusions on the safety and efficacy for the two products.
V zvezi z 2. vprašanjem je predlagatelj odgovoril, da ni razlik, ki bi upravičile različne zaključke o varnosti in učinkovitosti zdravil.
4/ 7 Under these conditions the applicant is exempted from submitting further preclinical or clinical data on efficacy of the proposed product, and can claim the same indications for use as for the reference product Tensolvet 50000.
4/ 7 Zaradi teh okoliščin predlagatelju ni treba predložiti dodatnih predkliničnih ali kliničnih podatkov o učinkovitosti predlaganega zdravila in lahko zahteva enake indikacije za uporabo, kot jih ima referenčno zdravilo Tensolvet 50000.
Compagel gel for horses proved to be essentially similar to the reference product, Tensolvet 50000.
Compagel gel za konje je dokazano bistveno podoben referenčnemu zdravilu Tensolvet 50000.
The objections raised by France and Sweden should not prevent the granting of a marketing authorisation for Compagel gel for horses.
Zadržki, ki sta jih podali Francija in Švedska, ne smejo preprečiti odobritve dovoljenja za promet z zdravilom Compagel gel za konje.
5/ 7 ANNEX III
5/ 7 DODATEK III
6/ 7 The valid Summary of Product Characteristics, labelling and package leaflet are the versions agreed by the Reference Member State and Concerned Member States (except France and Sweden) at day 90 of the mutual recognition procedure.
6/ 7 Veljavni Povzetek glavnih značilnosti zdravila, označevanje in Navodilo za uporabo so različice, s katerimi se strinjajo referenčna država članica in zadevne države članice (z izjemo Francije in Švedske) na 90. dan postopka medsebojnega priznavanja.
London, June 2008 EMEA/ 532160/ 2007 – Rev.1
London, junij 2008 EMEA/ 532160/ 2007 – Rev. 1
OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR DOLOVET
MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 33( 4) ZA ZDRAVILO DOLOVET
Dolovet vet 2.4g oral powder is a powder presented in sachets of 15g, each containing 2.4g ketoprofen and is authorised for the treatment of fever and inflammation in cattle.
Zdravilo Dolovet vet 2, 4 g je peroralni prašek v vrečkah po 15 g, pri čemer vsaka od njih vsebuje 2, 4 g ketoprofena, in je odobren za zdravljenje vročine in vnetij pri govedu.
The matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures, CMD(v), and subsequently to the Committee for Medicinal Products for Veterinary Use (CVMP).
Zadeva je bila napotena na Usklajevalno skupino za postopek z medsebojnim priznavanjem in decentralizirani postopek (CMD( v)) in naknadno na Odbor za zdravila za uporabo v veterinarski medicini (CVMP).
The CVMP during its meeting of 14-16 March 2006 started a referral procedure under Article 33(4) of Directive 2001/ 82/ EC, as amended.
Odbor za zdravila za uporabo v veterinarski medicini je na zasedanju od 14. do 16. marca 2006 sprožil napotitveni postopek v skladu s členom 33( 4) Direktive 2001/ 82/ ES, kakor je bila spremenjena.
The statistical report indicated that the number of animals used did not allow equivalence to be established (nor non-inferiority) between Dolovet containing ketoprofen administered orally at the dose of 4 mg/ kg bodyweight and Ketofen containing ketoprofen administered intramuscularly at the dose of 3 mg/ kg.
Statistično poročilo kaže, da število živali, uporabljenih v preskusu, ni omogočilo ocenitev enakovrednosti (niti neinferiornosti) med zdravilom Dolovet, ki vsebuje ketoprofen in se uporablja peroralno z odmerkom 4 mg/ kg telesne mase, ter zdravilom Ketofen, ki vsebuje ketoprofen in se uporablja intramuskularno z odmerkom 3 mg/ kg.
For well- established use dossiers the bridge can be constructed more tentatively.
Za dokumentacijo dobro uveljavljene uporabe je povezava lahko oblikovana bolj okvirno.
Considering the data provided and the well-established use of ketoprofen, the CVMP was of the opinion that the claim “ Alleviation of inflammation and reduction of fever in individual animals” had been substantiated.
Ob upoštevanju predloženih podatkov in dobro uveljavljeno uporabo učinkovine ketoprofen je Odbor za zdravila za uporabo v veterinarski medicini menil, da je trditev „ Lajšanje vnetij in zniževanje vročine pri posameznih živalih “ ustrezno utemeljena.
EMEA/ 532160/ 2007-Rev.1
EMEA/ 532160/ 2007- Rev. 1- SL
NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER
IME, FARMACEVTSKA OBLIKA, JAKOST ZDRAVILA, ŽIVALSKE VRSTE, NAČINI UPORABE ZDRAVILA IN IMETNIK DOVOLJENJA ZA PROMET
P. O. Box 99 24101 Salo Finland
P. O. Box 99 24101 Salo Finska
2.4g ketoprofen per sachet of 15g powder
2, 4 g ketoprofena v vsaki vrečki s 15 g praška
The powder should be mixed with water e. g. in a bottle using ½ litres of water, shaked well and administered immediately per orally to an animal.
Prašek je treba zmešati z vodo, npr. v steklenici s ½ litra vode, dobro pretresti in nemudoma dati živali peroralno.
Rifen 2.4g As above As above As above As above
Rifen 2, 4 g Kot zgoraj Kot zgoraj Kot zgoraj Kot zgoraj
SCIENTIFIC CONCLUSIONS
3 ZNANSTVENI ZAKLJUČKI
3 SCIENTIFIC CONCLUSIONS 1.
Uvod in obrazložitev
Introduction and background Dolovet vet 2.4g oral powder is a powder presented in sachets of 15g, containing 2.4g ketoprofen each.
Dolovet vet 2, 4 g peroralni prašek je na voljo v vrečkah po 15 g, ki vsebujejo po 2, 4 g ketoprofena.
In Finland the product has been authorised for the indication: “ The treatment of fever and inflammation in cattle”.
„ Zdravljenje zvišane telesne temperature in vnetja pri govedu “.
Following discussions in the CMD(v), the proposed indication was changed during the course of the MRP to: “ For the treatment of painful disorders (lameness; abdominal pain) in individual animals”.
„ Za zdravljenje bolečih obolenj (ohromelost; trebušne bolečine) pri posameznih živalih “.
The Reference Member State for the Mutual Recognition Procedure regarding Dolovet vet 2.4g oral powder, Finland, notified the EMEA on 2 March 2006 that the CMD(v) failed to reach an agreement regarding the product.
Referenčna država članica v postopku medsebojnega priznavanja zdravila Dolovet vet 2, 4 g peroralni prašek, Finska, je 2. marca 2006 obvestila EMEA, da v CMD( v) ni bilo doseženo soglasje o zdravilu.
Pursuant to Article 33(4) of Directive 2001/ 82/ EC, as amended, the matter was referred to the CVMP.
Zadeva je bila skladno s členom 33( 4) Direktive 2001/ 82/ ES, kot je spremenjena, napotena na Odbor za zdravila za uporabo v veterinarski medicini (CVMP).
The CVMP during its meeting of 14-16 March 2006 started a referral procedure under Article 33(4) of Directive 2001/ 82/ EC, as amended, for Dolovet vet 2.4g oral powder.
CVMP se je na sestanku 14. - 16. marca 2006 odločil, da za zdravilo Dolovet vet 2, 4 g peroralni prašek začne napotitveni postopek iz člena 33( 4) Direktive 2001/ 28/ ES, kot je spremenjena.
The responses were submitted to the EMEA on 12 September 2006.
Odgovori so bili predloženi EMEA 12. septembra 2006.
Discussion In his response the Marketing Authorisation Holder (MAH)did not develop any further the preclinical argument already presented during the mutual recognition procedure.
V odgovoru vlagatelj ni razširil predkliničnih argumentov, ki so že bili predstavljeni v postopku medsebojnega priznavanja.
However, a dose confirmation study, submitted with the response, is considered pivotal for the assessment of the efficacy: “ Dose confirmation of oral ketoprofen in endotoxin-induced mastitis in cows, Study 06-131-LC, August 7th, 2006”.
„ Določitev peroralnega odmerka ketoprofena pri mastitisu pri kravah, sproženem z endotoksinom, Raziskava 06- 131- LC, 7. avgust 2006 “.
This study was not available to CMD(v).
Raziskava ni bila dana na voljo skupini za usklajevanje medsebojnega priznavanja in decentraliziranih postopkov za veterinarska zdravila.
36 healthy lactating cows were challenged in one hindquarter, infused with endotoxin Bacto E. coli 026: B6 lipopolysaccharide B (LPS).
Pri 36 zdravih kravah v času laktacije so v eno zadnjo nogo infundirali endotoksin lipopolisaharid B (LPS) Bacto E. coli 026: B6.
Treatment was conducted two hours after challenge and the groups were Group A:
Zdravljenje je bilo izvedeno dve uri po vnosu endotoksina.
Saline, Group B:
Določili so naslednje skupine: skupina A: fiziološka raztopina, skupina B:
2 mg/ kg ketoprofen orally, Group C:
2 mg/ kg ketoprofena peroralno, skupina C:
4 mg/ kg ketoprofen orally, and Group D:
4 mg/ kg ketoprofena peroralno in skupina D:
3 mg/ kg ketoprofen intramuscularly.
3 mg/ kg ketoprofena intramuskularno.
Udder size, poor milk aspect, and pain also showed to be generally higher in the non-treated group.
Krave v nezdravljeni skupini so imele na splošno večje vime, slabše lastnosti mleka in več bolečin.
The results are clearly better for the treated groups when compared to non-treated animals for respiratory rate, rectal temperature, and ruminal contractions.
4 V zdravljenih skupinah so bili rezultati v zvezi s frekvenco dihanja, rektalno temperaturo in krči želodcev izrazito boljši kot v nezdravljeni skupini.