natgillin/translations-raw huggingface dataset:
Do not use in cases of hypersensitivity to oclacitinib or to any of the excipients.
Ne uporabite v primerih preobčutljivosti na oclacitinib ali na katero koli pomožno snov.
The impact of oclacitinib administration on vaccination with modified live vaccines, canine parvovirus (CPV), canine distemper virus (CDV) and canine parainfluenza (CPI) and inactivated rabies vaccine (RV), on 16 week old vaccine naïve puppies has been studied.
Pri predhodno necepljenih mladičih, starih 16 tednov, so preučili vpliv oklacitiniba na cepljenje z modificiranimi živimi cepivi, pasjim parvovirusom (CPV), virusom pasje kuge (CDV) in, virusom pasje parainfluence (CPI) ter inaktiviranim cepivom proti steklini (RV).
EU/2/13/154/001 (1 x 20 tablets, 3.6 mg) EU/2/13/154/007 (1 x 50 tablets, 3.6 mg) EU/2/13/154/002 (1 x 100 tablets, 3.6 mg) EU/2/13/154/010 (20 tablets, 3.6 mg) EU/2/13/154/011 (50 tablets, 3.6 mg) EU/2/13/154/012 (100 tablets, 3.6 mg) EU/2/13/154/003 (1 x 20 tablets, 5.4 mg) EU/2/13/154/008 (1 x 50 tablets, 5.4 mg) EU/2/13/154/004 (1 x 100 tablets, 5.4 mg) EU/2/13/154/013 (20 tablets, 5.4 mg) EU/2/13/154/014 (50 tablets, 5.4 mg) EU/2/13/154/015 (100 tablets, 5.4 mg) EU/2/13/154/005 (1 x 20 tablets, 16 mg) EU/2/13/154/009 (1 x 50 tablets, 16 mg) EU/2/13/154/006 (1 x 100 tablets, 16 mg) EU/2/13/154/016 (20 tablets, 16 mg) EU/2/13/154/017 (50 tablets, 16 mg) EU/2/13/154/018 (100 tablets, 16 mg)
EU/2/13/154/001 (1 x 20 tablet, 3,6 mg) EU/2/13/154/007 (1 x 50 tablet, 3,6 mg) EU/2/13/154/002 (1 x 100 tablet, 3,6 mg) EU/2/13/154/010 (20 tablet, 3.6 mg) EU/2/13/154/011 (50 tablet, 3.6 mg) EU/2/13/154/012 (100 tablet, 3.6 mg) EU/2/13/154/003 (1 x 20 tablet, 5,4 mg) EU/2/13/154/008 (1 x 50 tablet, 5,4 mg) EU/2/13/154/004 (1 x 100 tablet, 5,4 mg) EU/2/13/154/013 (20 tablet, 5.4 mg) EU/2/13/154/014 (50 tablet, 5.4 mg) EU/2/13/154/015 (100 tablet, 5.4 mg) EU/2/13/154/005 (1 x 20 tablet, 16 mg) EU/2/13/154/009 (1 x 50 tablet, 16 mg) EU/2/13/154/006 (1 x 100 tablet, 16 mg) EU/2/13/154/016 (20 tablet, 16 mg) EU/2/13/154/017 (50 tablet, 16 mg) EU/2/13/154/018 (100 tablet, 16 mg)
ATC vet code: QD11AH90.
Farmakoterapevtska skupina: Učinkovine za zdravljenje dermatitisa, razen kortikosteroidov Oznaka ATC vet: QD11AH90.
Tablet coating:
Ena filmsko obložena tableta vsebuje:
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Ne uporabite v primerih preobčutljivosti na oclacitinibali na katero koli pomožno snov.
The common adverse reactions seen up to day 16 of the field trials are listed in the following table: Adverse reactions observed in atopic dermatitis study up to day 16
Neželene reakcije, ki so jih opazili v študiji z atopičnim dermatitisom do dneva 16
The recommended initial dose is 0.4 to 0.6 mg oclacitinib/kg bodyweight, administered orally, twice daily for up to 14 days.
Priporočen začetni odmerek je 0,4 mg do 0,6 mg oklacitiniba/kg telesne mase, peroralno, dvakrat dnevno do 14 dni.
The recommended initial dose of Apoquel tablets to be given to the dog is to achieve 0.4 to 0.6 mg oclacitinib/kg bodyweight, administered orally, twice daily for up to 14 days.
Priporočen začetni odmerek tablet Apoquel za psa je 0,4 mg do 0,6 mg oklacitiniba/kg telesne mase, ki ga dajemo peroralno dvakrat dnevno do 14 dni.
EU/2/13/154/010 (20 tablets, 3.6 mg) EU/2/13/154/011 (50 tablets, 3.6 mg) EU/2/13/154/012 (100 tablets, 3.6 mg) EU/2/13/154/013 (20 tablets, 5.4 mg) EU/2/13/154/014 (50 tablets, 5.4 mg) EU/2/13/154/015 (100 tablets, 5.4 mg) EU/2/13/154/016 (20 tablets, 16 mg) EU/2/13/154/017 (50 tablets, 16 mg) EU/2/13/154/018 (100 tablets, 16 mg)
EU/2/13/154/010 (20 tablet, 3.6 mg) EU/2/13/154/011 (50 tablet, 3.6 mg) EU/2/13/154/012 (100 tablet, 3.6 mg) EU/2/13/154/013 (20 tablet, 5.4 mg) EU/2/13/154/014 (50 tablet, 5.4 mg) EU/2/13/154/015 (100 tablet, 5.4 mg) EU/2/13/154/016 (20 tablet, 16 mg) EU/2/13/154/017 (50 tablet, 16 mg) EU/2/13/154/018 (100 tablet, 16 mg)
No accumulation was observed in the blood of dogs treated for 6 months with oclacitinib.
Pri psih, ki so jih 6 mesecev zdravili z oklacitinibom, v krvi niso opazili akumulacije.
When treating pruritus associated with allergic dermatitis with oclacitinib, investigate and treat any underlying causes (e.g., flea allergic dermatitis, contact dermatitis, food hypersensitivity).
Pri uporabi oklacitiniba za zdravljenja pruritusa, povezanega z alergijskim dermatitisom, odkrijte in zdravite primarno bolezen (npr. alergijski dermatitis, ki ga povzročijo bolhe, kontaktni dermatitis, intoleranca na hrano).
EU/2/13/154/001 (1 x 20 tablets, 3.6 mg) EU/2/13/154/007 (1 x 50 tablets, 3.6 mg) EU/2/13/154/002 (1 x 100 tablets, 3.6 mg) EU/2/13/154/003 (1 x 20 tablets, 5.4 mg) EU/2/13/154/008 (1 x 50 tablets, 5.4 mg) EU/2/13/154/004 (1 x 100 tablets, 5.4 mg) EU/2/13/154/005 (1 x 20 tablets, 16 mg) EU/2/13/154/009 (1 x 50 tablets, 16 mg) EU/2/13/154/006 (1 x 100 tablets, 16 mg)
EU/2/13/154/001 (1 x 20 tablet, 3,6 mg) EU/2/13/154/007 (1 x 50 tablet, 3,6 mg) EU/2/13/154/002 (1 x 100 tablet, 3,6 mg) EU/2/13/154/003 (1 x 20 tablet, 5,4 mg) EU/2/13/154/008 (1 x 50 tablet, 5,4 mg) EU/2/13/154/004 (1 x 100 tablet, 5,4 mg) EU/2/13/154/005 (1 x 20 tablet, 16 mg) EU/2/13/154/009 (1 x 50 tablet, 16 mg) EU/2/13/154/006 (1 x 100 tablet, 16 mg)
Oclacitinib tablets were administered to healthy, one year old Beagle dogs twice daily for 6 weeks, followed by once per day for 20 weeks, at 0.6 mg/kg bw, 1.8 mg/kg bw and 3.0 mg/kg bw for a total of 26 weeks.
Tablete oklacitiniba so v odmerku 0,6 mg/kg telesne mase, 1,8 mg/kg telesne mase in 3 mg/kg telesne mase, v skupnem trajanju 26 tednov, dajali zdravim enoletnim psom pasme beagle, prvih 6 tednov dvakrat dnevno, nato 20 tednov enkrat dnevno.
The tablets are breakable along the score line.
Tablete je mogoče prelomiti po razdelilni zarezi.
Strength and number of tablets to be administered: Apoquel 3.6 mg tablets Apoquel 5.4 mg tablets Apoquel 16 mg tablets
Jakost in število tablet v odmerku: Apoquel 3,6 mg tablete Apoquel 5,4 mg tablete Apoquel 16 mg tablete
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Po dajanju zdravila si umijte roke.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation, or in breeding male dogs, therefore its use is not recommended during pregnancy, lactation or in dogs intended for breeding.
Varnost zdravila v obdobju brejosti in laktacije ni bila ugotovljena, zato uporaba ni priporočljiva.
For maintenance therapy, the same dose (0.4 to 0.6 mg oclacitinib/kg bodyweight) should then be administered only once a day.
Za vzdrževanje zdravljenja se daje enak odmerek (0,4 mg do 0,6 mg oklacitiniba/kg telesne mase) enkrat dnevno.
16 mg oclacitinib per tablet (as oclacitinib maleate).
16 mg oklacitiniba na tableto (kot oklacitinibijev maleat).
New cutaneous or subcutaneous lumps Lethargy
Anoreksija Pojav novih kožnih ali podkožnih vozličev
5.4 mg oclacitinib per tablet (as oclacitinib maleate).
5,4 mg oklacitiniba na tableto (kot oklacitinibijev maleat).
ANNEX I 0BSUMMARY OF PRODUCT CHARACTERISTICS
0BPOVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE LABEL for Bottle
PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI NALEPKA za steklenico
An adequate immune response (serology) to CDV and CPV vaccination was achieved when puppies were administered oclacitinib at 1.8 mg/kg bodyweight (bw) twice daily for 84 days.
Pri mladičih, ki so prejemali oklacitinib v odmerku 1,8 mg/kg telesne mase dvakrat dnevno 84 dni, so ugotovili primeren imunski odgovor na cepljenje proti CDV in CPV (serološko).
Apoquel 3.6 mg film-coated tablets for dogs Apoquel 5.4 mg film-coated tablets for dogs Apoquel 16 mg film-coated tablets for dogs oclacitinib
Apoquel 3,6 mg filmsko obložene tablete za pse Apoquel 5,4 mg filmsko obložene tablete za pse Apoquel 16 mg filmsko obložene tablete za pse oklacitinib
3.6 mg oclacitinib per tablet (as oclacitinib maleate).
NAVEDBA UČINKOVIN(E) 3,6 mg oklacitiniba na tableto (kot oklacitinibijev maleat).
New cutaneous or subcutaneous lumps Weakness (Lethargy) Excessive thirst (Polydipsia)
Zaspanost, otopelost (letargija)
PACKAGE LEAFLET: Apoquel 3.6 mg film-coated tablets for dogs Apoquel 5.4 mg film-coated tablets for dogs Apoquel 16 mg film-coated tablets for dogs
NAVODILO ZA UPORABO Apoquel 3,6 mg filmsko obložene tablete za pse Apoquel 5,4 mg filmsko obložene tablete za pse Apoquel 16 mg filmsko obložene tablete za pse
Apoquel 5.4 mg tablets
Apoquel 5,4 mg filmsko obložene tablete za pse
16 mg oclacitinib (as oclacitinib maleate) For the full list of excipients, see section 6.1.
Apoquel 3,6 mg: 3,6 mg oklacitiniba (kot oklacitinibijevega maleata) Apoquel 5,4 mg: 5,4 mg oklacitiniba (kot oklacitinibijevega maleata) Apoquel 16 mg: 16 mg oklacitiniba (kot oklacitinibijevega maleata) Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
Apoquel 16 mg tablets
Apoquel 16 mg filmsko obložene tablete za pse oklacitinib
The CHMP reviewed all the data available for each of the four sites concerned.
CHMP je pregledal vse razpoložljive podatke za vse štiri zadevne proizvodne obrate.
The present opinion is the first of a series of entwined opinions, which may result subsequently in additional measures being requested for the sites subject of the current opinion.
Trenutno mnenje je prvo v vrsti prepletajočih se mnenj, zaradi katerih bodo posledično morda potrebni dodatni ukrepi, ki jih bo treba izvesti v obratih, za katera bodo izdana mnenja.
Presently, the information available on the USA site is insufficient to conclude on its addition, pending the outcome of a recent inspection carried out at this site.
Podatki, ki so trenutno na voljo o proizvodnem obratu v ZDA, ne zadostujejo za potrditev njegove vključitve, saj je ta odvisna od izida nedavnega inšpekcijskega pregleda tega obrata.
A harmonised European approach to supply has been in place since identification of the concern at Castlebar and the article 31 procedure remains ongoing pending resolution of the outstanding issues.
Usklajen evropski pristop do oskrbe je vzpostavljen od ugotovitve, da obstajajo težave glede obrata v Castlebaru, postopek po členu 31 pa bo potekal, vse dokler odprta vprašanja ne bodo rešena.
Overall summary of the scientific evaluation on the inclusion of additional sites into the existing licenses of dialysis solutions (Dianeal, Extraneal and Nutrineal) produced by Baxter group of companies and associated companies (see Annex I)
Splošni povzetek znanstvenega vrednotenja vključitve dodatnih proizvodnih obratov v obstoječe licence za dializne raztopine (Dianeal, Extraneal in Nutrineal), ki jih proizvaja skupina družb in povezanih družb Baxter (glejte Prilogo I)
Taking into account the crucial nature of these medicinal products, unaffected batches of PD solutions had to be made available to patients across the EU in the shortest possible timeframe, and thus alternatives were sought.
Ob upoštevanju pomembnosti teh zdravil so morale biti enake serije raztopin za PD v najkrajšem možnem času na voljo bolnikom po vsej EU, zaradi česar so se iskala nadomestna zdravila.
• The CHMP considered the referral under Article 31 of Directive 2001/83/EC, as amended, for dialysis solutions produced at Castlebar by Baxter group of companies and associated companies.
• CHMP je proučil napotitev v skladu s členom 31 Direktive 2001/83/ES, kakor je bila spremenjena, za raztopine za dializo, ki jih v Castlebaru proizvaja skupina družb in povezanih družb Baxter.
Furthermore, the opinion on the Castlebar site cannot be finalised at this stage as issues remained for resolution by the marketing authorisation holder.
Prav tako tudi mnenje glede proizvodnega obrata v Castlebaru ne more biti dokončno, saj so v tej fazi še vedno odprta nekatera vprašanja, ki jih mora rešiti imetnik dovoljenja za promet z zdravilom.
• The CHMP considers that sufficient quality data is available to recommend the inclusion of manufacturing sites located in Canada, Poland and Turkey into the existing marketing authorisations for peritoneal dialysis solutions.
• CHMP meni, da so na voljo zadostni podatki o kakovosti, da lahko priporoči vključitev proizvodnih obratov v Kanadi, na Poljskem in v Turčiji v obstoječa dovoljenja za promet z zdravilom za raztopine za peritonealno dializo.
An article 31 referral procedure of Directive 2001/83/EC, as amended was initiated by the European Commission (EC) following reports of out-of-specifications results for endotoxins in dialysis solutions produced at Castlebar by Baxter group of companies and associated companies.
Napotitveni postopek v skladu s členom 31 Direktive 2001/83/ES, kakor je bila spremenjena, je sprožila Evropska komisija po poročanju o rezultatih izven specifikacijskih meja za endotoksine v dializnih raztopinah, proizvedenih v Castlebaru, v skupini družb in povezanih družb Baxter.
At this stage of the article 31 review procedure, sufficient data is available to recommend the variation to the marketing authorisations consisting in the inclusion of Canada, Poland and Turkey as additional manufacturing sites, as no major quality issues were identified at these sites.
V tej fazi postopka, ki je v skladu s členom 31, je na voljo dovolj podatkov, da se priporoči sprememba dovoljenj za promet z zdravilom, in sicer vključitev Kanade, Poljske in Turčije kot držav dodatnih proizvodnih obratov, saj v njih niso ugotovili nobenih večjih težav s kakovostjo.
the CHMP recommends the variation to the terms of the marketing authorisations concerning the addition of three manufacturing sites (Canada, Turkey and Poland) and for which the relevant amendments to sections of the summaries of product characteristics and package leaflets are set out in Annex III for dialysis solutions produced by Baxter group of companies and associated companies (see Annex I).
CHMP priporoča spremembo pogojev za dovoljenja za promet z zdravilom v zvezi z dodajanjem treh novih proizvodnih obratov (Kanada, Turčija in Poljska), za katera so v Prilogi III navedena ustrezna dopolnila poglavij povzetkov glavnih značilnosti zdravila in navodil za uporabo raztopin za peritonealno dializo, ki jih proizvaja skupina družb in povezanih družb Baxter (glejte Prilogo I).
Therefore, without prejudice to the ongoing article 31 procedure, the CHMP considers that sufficient information is available to issue a first opinion for this Article 31 procedure recommending the addition of Canada, Poland and Turkey manufacturing sites to the existing PD solutions' marketing authorisations, subject to conditions set out in the Annex IV.
Zato CHMP ne glede na potekajoči postopek v skladu s členom 31 meni, da je na voljo dovolj podatkov za izdajo prvega mnenja v tem postopku po členu 31, ki priporoča dodajanje proizvodnih obratov v Kanadi, na Poljskem in v Turčiji v obstoječa dovoljenja za raztopine za PD v skladu s pogoji, navedenimi v Prilogi IV. Na splošno je treba upoštevati naslednje:
Scientific conclusions and grounds for the addition of three manufacturing sites to the marketing authorisations and amendment of the summaries of product characteristics and package leaflets presented by the EMA
Znanstveni zaključki in podlaga za dodajanje treh novih proizvodnih obratov v dovoljenja za promet z zdravilom in dopolnilo povzetkov glavnih značilnosti zdravila in navodil za uporabo, ki jih je predstavila Evropska agencija za zdravila
Grounds for the addition of three manufacturing sites to the marketing authorisations and amendment of the summaries of product characteristics and package leaflets
Podlaga za dodajanje treh proizvodnih obratov v dovoljenja za promet z zdravilom ter dopolnilo povzetkov glavnih značilnosti zdravila in navodil za uporabo
Blister (PVC/PVDC) 63 (3 x 21) tablets
63 (3 x 21) tablet
Oral use
Stična ovojnina
This summary was last updated on 16/09/2010.
Povzetek je bil nazadnje posodobljen dne 16/09/2010.
Main potential risks for the vaccine as such:
Glavna možna tveganja cepiva so:
• for the consumer: all components have been investigated and no risk for the consumer has been identified.
• za potrošnika: raziskane so bile vse sestavine, pri čemer tveganje za potrošnika ni bilo ugotovljeno.
The risk using this inactivated vaccine can be classified as minimal.
Tveganje uporabe tega inaktiviranega cepiva lahko opredelimo kot minimalno.
The field efficacy results supported those obtained from the laboratory studies.
Rezultati glede učinkovitosti, pridobljeni na terenu, so podprli rezultate laboratorijskih študij.
Overall, the safety of this vaccine has been well documented and reported for the target animals, the user, the consumer and the environment.
Na splošno je varnost tega cepiva za ciljne živali, uporabnika, potrošnika in okolje dobro dokumentirana in opisana.
The European Commission granted a marketing authorisation valid throughout the European Union, for RHINISENG to Laboratorios Hipra S.A. on 16/09/2010.
Evropska komisija je dovoljenje za promet z zdravilom RHINISENG, veljavno po vsej Evropski uniji, odobrila družbi Laboratorios Hipra S.A. dne 16/09/2010.
The safety of RHINISENG was demonstrated in several well conducted and reported laboratory and field studies.
Varnost cepiva RHINISENG je bila dokazana v več dobro izvedenih in opisanih laboratorijskih in terenskih študijah.
Other information about RHINISENG:
Druge informacije o zdravilu RHINISENG:
• for the environment: no risk identified from the use of this inactivated vaccine
• za okolje: tveganja zaradi uporabe tega inaktiviranega cepiva niso bila ugotovljena.
• for the target animal: there are mild and transitory local reactions at the injection site, resolving within few days and a transiently elevated body temperature within acceptable limits.
• za ciljno žival: lahko se pojavijo blage in prehodne lokalne reakcije na mestu injiciranja, ki izginejo v nekaj dneh, ter prehodno zvišana telesna temperatura v sprejemljivem območju.
In the future, if the sows are exposed to the above mentioned bacteria, the immune system will be able to make those antibodies quicker and this will help their piglets to fight the disease and its after effects such as weight loss.
Če bodo v prihodnosti svinje izpostavljene zgoraj omenjenima bakterijama, bo lahko imunski sistem ta protitelesa izdelal hitreje, kar bo pujskom pomagalo pri premagovanju bolezni in njenih posledic, kot je izguba teže.
Results demonstrated that the vaccination of sows, gilts and boars according to the vaccination programme did not provoke unacceptable local or systemic reactions after vaccination and no significant differences in reproductive parameters between vaccinated and placebo-treated animals were recorded either.
Rezultati so pokazali, da cepljenje svinj, mladic in prašičev po cepilnem programu ni izzvalo nesprejemljivih lokalnih ali sistemskih reakcij po cepljenju, prav tako pa niso bile zabeležene pomembne razlike v parametrih razmnoževanja med cepljenimi živalmi in živalmi, ki so prejele placebo.
RHINISENG is a vaccine against a bacterial disease.
Zdravilo RHINISENG je cepivo proti bakterijski bolezni.
When it is given to sows, the animal's immune system (their natural defence mechanism) learns how to make antibodies (a special type of protein) to fight the disease.
Ko svinja prejme zdravilo, se imunski sistem (naravni obrambni mehanizem) živali nauči izdelovati protitelesa (posebno vrsto beljakovin) za boj proti bolezni.
The efficacy of RHINISENG was demonstrated for the category of the target species for which the vaccine is recommended (gilts and sows) by the recommended route of administration (intramuscular) using the proposed schedule of administration (first vaccination at 6-8 weeks before farrowing and revaccination 3-4 weeks later).
Učinkovitost zdravila RHINISENG je bila dokazana za kategorijo ciljne živalske vrste, za katero se cepivo priporoča (mladice in svinje) v skladu s priporočenim načinom uporabe (intramuskularno) in predlaganim režimom uporabe (prvo cepljenje pri 6-8 tednih pred prasitvijo ter ponovno cepljenje 3-4 tedne kasneje).
Rhiniseng is presented in fluid form as a suspension for injection which is stored in a glass or plastic bottle.
Zdravilo Rhiniseng je na voljo v obliki tekočine kot suspenzija za injiciranje, ki je shranjena v steklenički ali plastenki.
The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Razmerje med koristmi in tveganji je na voljo v modulu o znanstveni razpravi tega evropskega javnega poročila o oceni zdravila (EPAR).
Rhiniseng is a vaccine containing a non-toxic recombinant derivative of the Pasteurella multocida toxin and inactivated Bordetella bronchiseptica cells (inactivated means that the bacteria are killed so that they cannot cause the disease anymore).
Zdravilo Rhiniseng je cepivo, ki vsebuje netoksični rekombinantni derivat toksina bakterije Pasteurella multocida in inaktivirane celice Bordetella bronchiseptica (inaktivirane pomeni, da so bakterije uničene in da ne morejo več povzročiti bolezni).
What benefit has RHINISENG shown during the studies?
Kakšne koristi je zdravilo RHINISENG izkazalo med študijami?
As a consequence of reduced atrophic rhinitis disease, the incidence of respiratory symptoms and subsequent treatment with antibiotics of the pigs is also reduced.
Zaradi zmanjšanega atrofičnega rinitisa se zmanjšata tudi pojavnost simptomov v zvezi z dihali in poznejše zdravljenje prašičev z antibiotiki.
Inactivated vaccine to prevent progressive and non-progressive atrophic rhinitis in pigs
Inaktivirano cepivo za preprečevanje progresivnega in neprogresivnega atrofičnega rinitisa pri prašičih
It is used to reduce the clinical signs and lesions of a disease called progressive and non-progressive atrophic rhinitis, as well as to reduce weight loss associated with Bordetella bronchiseptica and Pasteurella multocida infections during the fattening period.
Uporablja se za zmanjšanje kliničnih znakov in lezij bolezni, imenovane progresivni in neprogresivni atrofični rinitis, ter za zmanjšanje izgube teže, povezane z okužbo z bakterijama Bordetella bronchiseptica in Pasteurella multocida v obdobju pitanja.
RHINISENG is used for the protection of piglets via the sow's colostrum (first milk) after injection of sows and gilts.
Zdravilo RHINISENG se uporablja za zaščito pujskov prek kolostruma (prvega mleka) svinje po cepljenju svinj in mladic.
These antibodies are then transferred to the piglets via the colostrum they receive.
Ta protitelesa se nato prenesejo v pujske s kolostrumom.
What is the risk associated with RHINISENG?
Kakšna tveganja so povezana z zdravilom RHINISENG?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of RHINISENG exceed the risks for the treatment of piglets via colostrum from sows and gilts actively immunised with the vaccine to prevent the clinical signs and lesions of progressive and nonprogressive atrophic rhinitis and recommended that RHINISENG be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila RHINISENG pri zdravljenju pujskov prek kolostruma po aktivni imunizaciji svinj in mladic za preprečevanje kliničnih znakov in lezij progresivnega in neprogresivnega atrofičnega rinitisa večje od z njim povezanih tveganj, zato je priporočil odobritev dovoljenja za promet z zdravilom RHINISENG.
RHINISENG reduces the incidence and severity of the disease called progressive and non-progressive atrophic rhinitis in pigs.
Zdravilo RHINISENG zmanjša pojavnost in resnost bolezni, imenovane progresivni in neprogresivni atrofični rinitis pri prašičih.
Why has RHINISENG been approved?
Zakaj je bilo zdravilo RHINISENG odobreno?
The pigs, which have received antibodies against progressive atrophic rhinitis via colostrum, need a shorter time to reach the slaughter weight.
Prašiči, ki so prejeli protitelesa proti progresivnemu atrofičnemu rinitisu s kolostrumom, prej dosežejo maso za klanje.
This is reflected in the relevant sections of the SPC.
Te reakcije so navedene v ustreznih poglavjih povzetka glavnih značilnosti zdravila.
How has RHINISENG been studied?
Kako je bilo zdravilo RHINISENG raziskano?
What is RHINISENG used for?
Za kaj se zdravilo RHINISENG uporablja?