natgillin/translations-raw huggingface dataset:
An
Pomembno je izpostaviti, da je bila v vseh teh eksperimentalnih pogojih opažena razlika v velikosti inokulirane četrti vimena.
4 anti-oedemic effect is usually evaluated over several days, and an NSAID may be considered limited in its efficacy here.
Učinek zmanjšanja otekline se ponavadi ocenjuje več dni in nesteroidna protivnetna zdravila (NSAID) imajo tukaj omejeno učinkovitost.
Opposed to injectable ketoprofen the results for milk are not “ as clear ” for Dolovet as what they are for plasma.
V nasprotju s ketoprofenom za injiciranje rezultati preiskav mleka za zdravilo Dolovet niso „ tako jasni “ kot rezultati preiskav plazme.
The statistical report indicates that the number of animals used does not allow to establish equivalence (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 je uporabljeno število živali premajhno za dokaz enakovrednosti (ali neinferiornosti) med zdravilom Dolovet s ketoprofenom peroralno v odmerku 4 mg/ kg telesne mase in zdravilom Ketofen s ketoprofenom intramuskularno v odmerku 3 mg/ kg.
However, given that the pharmacokinetic data allowed to optimise the dose (keeping overall exposure comparable between the two products), it is concluded that a bridge exists that allows well- established use to apply to Dolovet.
Vendar se glede na to, da so farmakokinetični podatki omogočili optimizacijo odmerka (z ohranjanjem primerljivosti celokupne izpostavljenosti med obema zdraviloma), lahko zaključi, da obstaja povezava, ki omogoča dobro utemeljeno uporabo zdravila Dolovet.
For well-established use dossiers the bridge can be constructed a bit more tentatively.) To restrict the indications of Dolovet to only those that were tested (endotoxemic mastitis control) would be inappropriate.
Omejevanje indikacij zdravila Dolovet izključno na indikacije, ki so bile preizkušene (zdravljenje endotoksemijskega mastitisa), bi bilo neprimerno.
Conclusion Reducing of pyrexia or fever and alleviation of inflammation are considered important clinical claims that should be retained as they have been demonstrated clearly enough.
Zaključek Zniževanje pireksije oz. zvišane telesne temperature in lajšanje vnetja se štejeta za pomembna klinična zahtevka in ju je treba ohraniti v indikacijah, saj sta bila zadostno dokazana.
Dolovet vet 2.4 g oral powder.
Dolovet vet 2, 4 g peroralni prašek
1 sachet= 15 g powder contains:
15 g praška (1 vrečka) vsebuje:
4.1 Target species
4. 1 Ciljne živalske vrste
4.2 Indications for use, specifying the target species
4. 2 Indikacije za uporabo pri ciljnih živalskih vrstah
Alleviation of inflammation and reduction of fever in individual animals
Lajšanje vnetnih procesov in zniževanje povišane telesne temperature pri posameznih živalih.
Not known.
Jih ni.
4.5 Special precautions for use
4. 5 Posebni previdnostni ukrepi
The recommended dose and treatment time must not be exceeded.
Ne presezite priporočenega odmerka in trajanja zdravljenja.
8 People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAID) should avoid contact with the veterinary medicinal product.
Osebe z znano preobčutljivostjo na nesteroidna protivnetna zdravila (NSPVZ) naj se izogibajo stiku z zdravilom.
Ketoprofen may cause adverse reactions typical to non-steroidal anti-inflammatory drugs such as diarrhoea which is caused by gastro-intestinal irritation and ulceration.
Ketoprofen lahko povzroči neželene učinke, tipične za nesteroidna protivnetna zdravila, kot so diareja, ki nastopi zaradi draženja prebavil, in razjede (ulceracije).
4.8 Interaction with other medicinal products and other forms of interaction
4. 8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Other non steroidal anti-inflammatory drugs (NSAID) must not be used simultaneously with the product and within 24 hours after the last dose of Dolovet because the substances may compete in binding with proteins thus leading to toxic effects.
Istočasno in še 24 ur po zadnjem odmerku Dolovet vet praška ne smemo uporabiti drugih nesteroidnih protivnetnih zdravil (NSPVZ), ker bi učinkovine lahko tekmovale v vezavi na beljakovine, kar lahko privede do toksičnih učinkov.
4.9 Amounts to be administered and administration route
4. 9 Odmerjanje in pot uporabe
For adult cattle weighing about 600 kg bw.:
Odraslo govedo (težko okrog 600 kg):
One bag of 15 g once daily for 1 - 3 days.
1 vrečka (15 g) praška enkrat na dan, kar ustreza 4 mg ketoprofena na kg.
This corresponds to 4 mg ketoprofen / kg.
1 – 3 dni.
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.
Zdravilo zmešamo s 0, 5 l vode za pitje (npr. v steklenici), dobro pretresemo in takoj apliciramo živali peroralno.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4. 10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno)
4.11 Withdrawal period(s)
4. 11 Karenca
1 day.
1 dan.
ATCvet code:
Farmakoterapevtska skupina: protivnetna in protirevmatska zdravila, nesteroidna (derivati propionske kisline), oznaka ATC vet:
QM01AE03
QM01AE03.
9 enxyme inhibits the formation of the inflammation mediators PGE2 and PGI2.
Blokada encima ciklooksigenaza zavira tvorbo prenašalcev vnetja PGE2 in PGI2.
Ketoprofen has been shown to inhibit the intravenously injected E. coli endotoxin induced tromboxane B2 production in the bovine.
Pri govedu se je pokazalo, da ketoprofen zavira tudi z intravensko injiciranim endotoksinom E. coli inducirano tvorbo tromboksana B2.
5.2 Pharmacokinetic particulars
5. 2 Farmakokinetični podatki
In cattle, after the recommended dose of 4 mg/ kg of ketoprofen per os before feeding the concentrate, the highest concentration of ketoprofen in plasma (Cmax3,9 µg/ ml) was achieved in about 2 hours.
9 Po uporabi priporočenega odmerka 4 mg ketoprofena / kg (peroralni vnos pred krmljenjem koncentratov) je bila pri govedu najvišja vsebnost ketoprofena v plazmi (Cmax 3, 9 µg/ ml) dosežena v približno 2 urah.
The elimination half life after per oral administration was about 4,5 hours.
Razpolovni čas izločanja po peroralnem vnosu je znašal približno 4, 5 ure.
Concentrations over 0,1 µg/ ml in plasma were measured 24 hours after the administration of the drug.
24 ur po uporabi zdravila so v plazmi izmerili vsebnost ketoprofena, višjo od 0, 1 µg/ ml.
The bioavailability after per-oral dosing is about 76%.
Biološka razpoložljivost po peroralnem odmerjanju je približno 76%.
- Carmellose sodium
Maltodekstrin, natrijev karmelozat.
6.5 Nature and composition of immediate packaging
6. 5 Vrsta ovojnine in vsebina
3 x 15 g.
15 g vrečke iz aluminijske folije, pakirane v kartonsko škatlo, 3 x 15 g.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
6. 6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
Box 99, 24101 Salo.
Box 99, 24101 Salo, Finska
MARKETING AUTHORISATION NUMBER(S):
ŠTEVILKA( E) DOVOLJENJ( A) ZA PROMET
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATUM REVIZIJE BESEDILA
22.09.2003
10. 11. 2006
10 DATE OF REVISION OF THE TEXT
10 Navedba ni smiselna.
12 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
12 PODATKI NA ZUNANJI OVOJNINI
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
15 g praška (1 vrečka) vsebuje: ketoprofen
Ketoprofen 2.4 g, constit. q. s. ad 15g.
2, 4 g
Cattle (adult cattle weighing about 600 kg).
Govedo (odraslo govedo, težko okoli 600kg).
METHOD AND ROUTE(S) OF ADMINISTRATION, POSOLOGY
NAČIN IN POT UPORABE
Orally for adult cattle weighing about 600 kg bw.:
Govedo (težko okrog 600 kg):
One bag of 15 g once daily for 1 - 3 days.
1 vrečka (15 g) enkrat dnevno, peroralno.
This corresponds to 4 mg ketoprofen / kg.
1 do 3 dni.
1 day Milk: zero days
Mleko: nič dni.
SPECIAL WARNING(S), IF NECESSARY
POSEBNO( A) OPOZORILO( A), ČE JE/ SO POTREBNO( A)
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OF RESTRICTIONS REGARDING SUPPLY AND USE
BESEDILO “ SAMO ZA ŽIVALI ” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je navedba smiselna
THE WORDS “ KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
BESEDILO “ ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM ”
The marketing authorisation holder:
Imetnik dovoljenja za promet z zdravilom:
Box 99, 24101 Salo
Box 99, 24101 Salo, Finska
The manufacturer responsible for batch release:
Izdelovalec, odgovoren za sproščanje serije:
Galena Oy, P. O. Box 1450, 70501 Kuopio, Finland
Box 1450, 70501 Kuopio, Finland
MARKETIN AUTHORISATION NUMBER
ŠTEVILKA( E) DOVOLJENJ( A) ZA PROMET
MANUFACTURER’ S BATCH NUMBER
IZDELOVALČEVA ŠTEVILKA SERIJE
QUANTITY OF THE ACTIVE SUBSTANCE(S)
KOLIČINA ZDRAVILNE( IH) UČINKOVIN( E)
Ketoprofen 2.4 g
ketoprofen 2, 4 g
ROUTE(S) OF ADMINISTRATION AND POSOLOGY
POT( I) UPORABE ZDRAVILA
This corresponds to 4 mg ketoprofen / kg.
Odmerek ustreza 4 mg ketoprofena / kg.
THE WORDS “ FOR ANIMAL TREATMENT ONLY”
BESEDILO “ SAMO ZA ŽIVALI ”
(Cattle)
Samo za živali (govedo).
16 PACKAGE LEAFLET
16 NAVODILO ZA UPORABO
Dolovet vet 2.4 g oral powder
Dolovet vet 2, 4 g peroralni prašek
Vetcare Oy, P. O. Box 99, 24101 Salo, Finland.
Box 99, 24101 Salo, Finska
Oy Galena Ltd, P. O. Box 1450, 70501 Kuopio, Finland
Box 1450, 70501 Kuopio, Finland
Dolovet vet 2.4 g oral powder.
Dolovet vet 2, 4 g peroralni prašek ketoprofen
STATEMENT OF THE ACTIVE AND OTHER INGREDIENTS
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGEIH SESTAVIN
1 sachet= 15 g powder contains of 2.4 g ketoprofen and exipients to 15 g.
1 vrečka (15 g praška) vsebuje 2, 4 g ketoprofena in pomožne snovi do 15g.
Alleviation of inflammation and reduction of fever in individual animals
Lajšanje vnetnih procesov in zniževanje povišane telesne temparature pri posameznih živalih.
Simultaneous use of loop- diuretics (for example furosemid) may decrease the effect of the diuretic.
Istočasna uporaba diuretikov, ki delujejo na ledvično zanko (npr. furosemid), lahko zniža učinek diuretikov.
Cattle (adult cattle weighing about 600 kg).
17 Govedo (odraslo govedo, težko okoli 600kg).
Oral use.
Pot uporabe zdravila: peroralna uporaba
Meat and offail:
Meso in organi:
1 day Milk: zero days.
Mleko: nič dni.
To the user:
Za uporabnika:
18
18 3. 8. 2005 (datum zadnje revizije:
NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER Member State
IME, FARMACEVTSKA OBLIKA, JAKOST ZDRAVILA, ŽIVALSKE VRSTE, NAČINI UPORABE ZDRAVILA IN IMETNIK DOVOLJENJA ZA PROMET
Frequency and route of administration
Pogostost in pot Priporočeni uporabe zdravila odmerek
Belgium, Czech Republic, Germany, Greece, Spain, France, Italy, The Netherlands, Poland, Portugal and Slovakia
Belgija, Češka republika, Nemčija, Grčija,
Premix
premiks
Pigs (after weaning)
prašiči (po
In feed use
uporaba v krmi
10 mg/ kg. bw
10 mg/ kg TM
2/ 21 ANNEX II
2/ 21 DODATEK II
3/ 21 SCIENTIFIC CONCLUSIONS
3/ 21 ZNANSTVENI ZAKLJUČKI
Doxyprex 100 mg premix presented in 5 kg, 20 kg and 25 kg thermosealed bags containing 100 mg/ g doxycycline base as hyclate.
Zdravilo Doxyprex 100 mg premiks je na voljo v 5 kg, 20 kg ali 25 kg toplotno varjenih vrečah, ki vsebujejo doksiciklin v obliki hiklata.
Following discussions in the CMD(v), the proposed indication was changed during the course of the MRP to: “ For treatment of swine respiratory disease caused by susceptible Pasteurella multocida, Bordetella bronchiseptica and Mycoplasma hyopneumoniae to doxycycline. ” Germany notified the EMEA on 30 May 2006 that the CMD(v) failed to reach an agreement regarding the product.
„ Za zdravljenje bolezni dihal pri prašičih, ki jo povzročajo za doksiciklin občutljive bakterije Pasteurella multocida, Bordetella bronchiseptica in Mycoplasma hyopneumoniae. “ Nemčija je 30. maja 2006 obvestila agencijo EMEA, da v usklajevalni skupini CMD( v) ni bilo doseženo soglasje o zdravilu.
The CVMP during its meeting of 21-22 June 2006 started a referral procedure under Article 33(4) of Directive 2001/ 82/ EC, as amended, for Doxyprex 100 mg premix.
CVMP je na sestanku 21. - 22. junija 2006 za zdravilo Doxyprex 100 mg premiks začel napotitveni postopek po členu 33( 4) Direktive 2001/ 28/ ES, kakor je spremenjena.
In the introduction to the responses the applicant has given a justification for submission of this application on a “ well-established use” basis.
Vlagatelj je v uvodu k odgovorom utemeljil svojo vlogo z argumentom „ dobro uveljavljene uporabe “.
Within the EU doxycycline-based premix products for pigs at recommended dose rates of 10mg/ kg once daily for 5 days are stated as having been authorised since 1985.
Navaja, da so bili v EU premiksi na osnovi doksiciklina za prašiče pri priporočenih odmerkih 10 mg/ kg enkrat dnevno v trajanju zdravljenja 5 dni odobreni od leta 1985.
Annex I of Directive 2001/ 82/ EC as amended by directive 2004/ 28/ EC notes that post-marketing experience with other products containing the same constituents is of particular importance and applicants should put a special emphasis on this issue.
Priloga I k Direktivi 2001/ 82/ ES, kakor je bila spremenjena z Direktivo 2004/ 28/ ES, določa, da so zelo pomembne izkušnje, pridobljene po uvedbi drugih zdravil v promet, ki vsebujejo enake sestavine, in da se morajo vlagatelji tej problematiki posebej posvetiti.
Pivotal clinical trial with Doxycyline 10% premix
Ključno klinično preskušanje doksiciklina 10% premiks
4/ 21 Although the choice of positive controls would not be acceptable when assessed under current standards, the CVMP concluded that the applicant has justified that at the time there were no doxycycline based authorised premix for the proposed indications.
4/ 21 Čeprav izbira pozitivnih kontrol ne bi bila sprejemljiva, če bi se vrednotila na podlagi trenutno veljavnih standardov, je CVMP zaključil, da je vlagatelj z navedbo, da odobreni premiksi na osnovi doksiciklina za predlagane indikacije v času izvedbe preskušanja niso bili na voljo, podal sprejemljivo utemeljitev.
The main object was to try to ensure intake of the proposed dose of 10 mg/ kg b. w.
Glavni cilj je bil zagotoviti vnos predlaganega odmerka 10 mg/ kg TM.
Less emphasis should be put on the standard incorporation of 250 ppm. related to “ normal” food consumption.
Standardno dodajanje 250 ppm pri „ normalnem “ vnosu krme je treba manj poudarjati.
The CVMP/ 627/ 01 and GCP guideline stated that the response to therapy must be based on clinical and microbiological criteria wherever possible.
Dokument CVMP/ 627/ 01 in smernice za dobro klinično prakso (GCP) določajo, da je treba odziv na zdravljenje opredeliti s kliničnimi in mikrobiološkimi kriteriji, kjer je možno.
In the pivotal clinical trial, the presence of P. multocida and B. bronchiseptica was clearly demonstrated in sick pigs, however no post treatment sampling was done to show bacteriological cure.
V ključnem kliničnem preskušanju so pri obolelih prašičih nedvoumno dokazali prisotnost P. multocida in B. bronchiseptica, vendar niso odvzeli vzorcev po zdravljenju za dokaz bakteriološke ozdravitve.
The applicant justifies that the presence of M. hyopneumoniae was not determined by bacteriological methods because it was difficult to isolate at that time.
Vlagatelj pojasnjuje, da prisotnosti M. hyopneumoniae niso določevali z bakteriološkimi metodami, ker je bilo v času raziskave ta organizem težko osamiti.
The applicant provided evidence of efficacy of the active substance, doxycycline, against M. hyopneumoniae in pigs from published literature and from MIC studies.
Vlagatelj je predložil dokaze o učinkovitosti zdravilne učinkovine, doksiciklina, zoper M. hyopneumoniae pri prašičih iz objavljenih virov in študij MIK.
Farms were selected if at least 20% of pigs were showing clinical signs of respiratory disease.
Kmetije so bile izbrane, če je najmanj 20% prašičev kazalo klinične znake bolezni dihal.
The clinical end points were ” Time to clinical cure” and ” overall clinical cure”.
Klinični končni točki sta bili „ čas do klinične ozdravitve “ in „ celokupna klinična ozdravitev “.
“ For the treatment and prevention of porcine respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica, susceptible to doxycycline, when the disease has been diagnosed in the herd. “
„ Za zdravljenje in preprečevanje bolezni dihal pri prašičih, ki jo povzročajo za doksiciklin občutljivi bakteriji Pasteurella multocida in Bordetella bronchiseptica, ko je bolezen v čredi dokazana. “
The Committee agreed that all prudent use recommendations should be put under 4.5.
5/ 21 Odbor se je strinjal, da se vsa priporočila za preudarno rabo navedejo v poglavju 4. 5.
5/ 21 Amendments to the pharmacokinetic section of the SPC and the origin of the MIC values included in this section should be inserted, too.
V povzetku glavnih značilnosti zdravila je treba spremeniti tudi poglavje o farmakokinetiki in dodati vire k vrednostim MIK, ki so navedene v tem poglavju.
The applicant felt that this was more adapted towards the Guideline EMEA/ CVMP/ 816/ 00 and obtained greater clinical significance.
Vlagatelj meni, da je to statistično vrednotenje bolj prilagojeno smernici EMEA/ CVMP/ 816/ 00 in da zagotavlja večji klinični pomen.
A new primary end point was defined as Time to clinical cure, i. e. the time to absence of clinical signs.
Opredeljena je bila nova primarna končna točka: čas do klinične ozdravitve, tj. čas do izginotja kliničnih znakov.
For Time to clinical cure, Doxyprex at 200ppm and at 300ppm groups were cured at 3.2 and 3.33 days respectively compared to the TM550 group at 8.2 days, the Stabox group at 11.75 days and the control group at 13.67 days.
Glede časa do klinične ozdravitve je bila skupina, zdravljena z zdravilom Doxyprex v odmerku 200 ppm, ozdravljena v 3, 2 dneh, medtem ko je bila skupina, zdravljena z odmerkom 300 ppm, ozdravljena v 3, 33 dneh v primerjavi s skupino s TM550, ki je bila ozdravljena v 8, 2 dneh; skupina, ki je prejemala zdravilo Stabox, je bila ozdravljena v 11, 75 dneh, kontrolna skupina pa v 13, 67 dneh.
The CVMP concluded that according to “ current” GCP requirements this pivotal study design has many deficiencies.
CVMP je sklenil, da ima ključna raziskava številne pomanjkljivosti po „ trenutno veljavnih “ zahtevah iz smernic za dobro klinično prakso.
Although on the surface the individual numbers of pigs involved looks small, the applicant has justified that because of the large difference in results between the Doxyprex and control groups the small number of animals still allows a 80% power to be achieved.
Čeprav morda število vključenih prašičev zgleda majhno, vlagatelj trdi, da velika razlika med rezultati za zdravilo Doxyprex in rezultati iz kontrolnih skupin še vedno omogoča 80- odstotno moč raziskave pri majhnem številu živali.
Deficiencies in the pivotal clinical trial demonstrating efficacy of the product for the treatment of P. multocida and B. bronchiseptica were compensated for by a discussion of the field data in the literature reference provided.
Pomanjkljivosti pri ključnem kliničnem preskušanju, ki je pokazalo učinkovitost zdravila pri zdravljenju okužb z P. multocida in B. bronchiseptica, so nadomestili s preučitvijo terenskih podatkov v priloženih virih literature.
In conclusion the applicant has justified their application as well-established use of the active substance, doxycycline.
Končna ugotovitev je, da je vlagatelj utemeljil svojo vlogo na osnovi dobro uveljavljene rabe zdravilne učinkovine – doksiciklina.
The submitted references supported pharmacodynamics including MIC data (more than 5 years old) and pharmacokinetics of the active substance, doxycycline.
Predloženi viri podpirajo farmakodinamiko, vključno s podatki o MIK (starimi več kot 5 let), in farmakokinetiko zdravilne učinkovine – doksiciklina.
The applicant conducted a pivotal controlled, randomized two-centred field trial using their final formulation to demonstrate efficacy for respiratory disease caused by P. multocida and B. bronchiseptica.
Vlagatelj je opravil ključno, kontrolirano, randomizirano, dvocentrično, terensko preskušanje končne formulacije za dokaz učinkovitosti zdravila pri zdravljenju okužb zaradi P. multocida in B. bronchiseptica.
(1) Pharmacovigilance – reporting a nil return for suspected adverse drugs reactions and lack of efficacy; and (2) Five expert opinions written by veterinarians who work closely with large pigs farms in Spain, all containing positive comments on their use of this product.
Na osnovi vseh teh podatkov ni mogoče
From all this information, a significant potential serious risk for safety or efficacy of Doxyprex, for the treatment or control of clinical signs of porcine respiratory disease caused by P. multocida and B. bronchiseptica cannot be identified.
6/ 21 določiti pomembnega potencialno resnega tveganja glede varnosti ali učinkovitosti zdravila Doxyprex pri zdravljenju ali nadzorovanju kliničnih znakov bolezni dihal pri prašičih, ki jo povzročata P. multocida in B. bronchiseptica.
For the second clinical study “ Efficacy of the doxycycline in feed for the control of pneumonia caused by P. multocida and Mycoplasma hyopneumoniae
Glede druge klinične študije „ Učinkovitost doksiciklina v krmi za nadzor pljučnice, ki jo povzročata P. multocida in Mycoplasma hyopneumoniae “
6/ 21 No dose confirmation studies appear to have been presented in this study and therefore it was important that the references provided should present robust evidence for the field efficacy of the product.
V tej raziskavi ni bilo predstavljenih študij potrjevanja odmerka, zato je pomembno, da priloženi viri posredujejo trdne dokaze o učinkovitosti zdravila na terenu.
In order to establish that Doxyprex is similarly bioavailable to the product Pulmodox 5% Premix, the applicant referred to information from the SPC and the hevra. org website.
Vlagatelj je za dokaz podobne biološke dostopnosti med zdravilom Doxyprex in Pulmodox 5% premiks navedel podatke iz povzetka glavnih značilnosti zdravila in spletni naslov hevra. org.
There are however differences in both dose recommendation (12.5 mg/ kg/ day versus 10 mg/ kg/ day) and duration of treatment (8 versus 7 days).
Obstajajo pa razlike v priporočenem odmerjanju (12, 5 mg/ kg/ dan v primerjavi z 10 mg/ kg/ dan) in trajanju zdravljenja (8 dni v primerjavi s 7 dnevi).
Based on this information the CVMP agreed that the provided references are not suitable as pivotal evidence of clinical efficacy of the product Doxyprex for the proposed indication and dose regimen for M. Hyopneumoniae
Na podlagi teh podatkov CVMP soglaša, da predloženi viri niso primerni kot ključni dokaz klinične učinkovitosti zdravila Doxyprex za predlagano indikacijo in režim odmerjanja za M. hyopneumoniae.
Conclusion and recommendation The CVMP recommendation is to grant the marketing authorisation to Doxyprex 100 mg/ g Premix for medicated feeding stuff for pigs the following suggested indication because a positive risk: benefit analysis has been demonstrated and no potential serious risk has been identified.
Sklep in priporočilo CVMP priporoča odobritev dovoljenja za promet za zdravilo Doxyprex 100 mg/ g premiks za medicinirano krmo za prašiče s spodnjo indikacijo, saj je bilo dokazano pozitivno razmerje med tveganji in koristnimi učinki, potencialna resna tveganja pa niso bila ugotovljena.
“ For the treatment and prevention of porcine respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica, susceptible to doxycycline, when the disease has been diagnosed in the herd. ” A risk: benefit analysis could not be conducted due to the lack of pivotal evidence on clinical efficacy for the indication M. hyopneumoniae.
„ Za zdravljenje in preprečevanje bolezni dihal pri prašičih, ki jo povzročajo za doksiciklin občutljive bakterije Pasteurella multocida in Bordetella bronchiseptica, ko je bolezen v čredi dokazana. “ Analize tveganj in koristnih učinkov za indikacijo M. hyopneumoniae ni bilo možno opraviti zaradi pomanjkanja ključnih dokazov o klinični učinkovitosti za to indikacijo.
7/ 21 ANNEX III
7/ 21 DODATEK III
8/ 21 SUMMARY OF PRODUCT CHARACTERISTICS
8/ 21 POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
Doxyprex 100 mg/ g Premix
Doxyprex 100 mg/ g predmešanica
Each gram contains:
Vsak gram vsebuje: