natgillin/translations-raw huggingface dataset:
Caution is advised if co-administering Viekirax with medicinal products that are both moderate inhibitors of CYP3A4 and inhibitors of multiple transporters (P-gp, BCRP and/or OATP1B1/ OATP1B3).
Viekirax z zdravili, ki so zmerni zaviralci CYP3A4 in zaviralci več prenašalcev (P-gp, BCRP in/ali
Viekirax and dasabuvir with RBV Arm A 12 Weeks N = 31
Viekirax in dasabuvir z RBV Skupina A 12 tednov N = 31
Mechanism: OATP1B1 inhibition by paritaprevir.
OATP1B1 z paritaprevirjem
Viekirax and dasabuvir with investigator chosen ribavirin dose for 24 weeks
Zdravljenje: Viekirax in dasabuvir z odmerkom ribavirina, ki ga izbere raziskovalec, 24 tednov
TURQUOISE-II - treatment-naïve or pegIFN + RBV-experienced with compensated cirrhosis
TURQUOISE-II - še nezdravljeni ali že zdravljeni s pegIFN + RBV, s kompenzirano cirozo
Viekirax + dasabuvir atazanavir
Viekirax + ↔ atazanavir
Mechanism: CYP3A4/Pgp inhibition by erythromycin, paritaprevir, ritonavir and dasabuvir.
CYP3A4/P-gp z eritromicinom, paritaprevirjem, ritonavirjem in dasabuvirjem
Hepatobiliary Disorders: Hepatic decompensation, hepatic failure have been observed during treatment with Viekirax with and without dasabuvir and with or without ribavirin (see section 4.4).
Bolezni jeter, žolčnika in žolčevodov: med zdravljenjem z zdravilom Viekirax z ali brez dasabuvirja in z ali brez ribavirina so opazili dekompenzacijo jeter in okvaro jeter (glejte poglavje 4.4).
Drug interactions were evaluated for the Viekirax and dasabuvir regimen, but not for the Viekirax without dasabuvir, with carbamazepine, furosemide, zolpidem, darunavir twice daily, darunavir (evening administration), atazanavir (evening administration), rilpivirine, abacavir/lamivudine, dolutegravir, metformin, sulfamethoxazole/trimethoprim, cyclobenzaprine, carisoprodol, hydrocodone/ paracetamol or diazepam.
(uporaba zvečer), rilpivirinom, abakavir/lamivudinom, dolutegravirjem, metforminom, sulfametoksazol/trimetoprimom, ciklobenzaprinom, karisoprodolom, hidrokodon/paracetamolom ali diazepamom.
Viekirax and dasabuvir without ribavirin or with weight-based ribavirin for 12 weeks Treated subjects (N=305) had a median age of 54 years (range: 19 to 70); 65.2% were male; 11.8% were Black; 20.7% had a history of depression or bipolar disorder; 86.6% had baseline HCV RNA levels of at least 800,000 IU/mL; 18.4% had portal fibrosis (F2) and 17.7% had bridging fibrosis (F3).
Zdravljenje: Viekirax in dasabuvir brez ribavirina ali z ribavirinom, odvisnim od telesne mase, 12 tednov Zdravljeni preiskovanci (N = 305) so bili mediano stari 54 let (razpon: od 19 do 70); 65,2 % je bilo moških; 11,8 % je bilo črncev; 20,7 % jih je imelo v anamnezi depresijo ali bipolarno motnjo; 86,6 % jih je imelo izhodiščno koncentracijo HCV RNA vsaj 800.000 i. e./ml; 18,4 % jih je imelo portalno fibrozo (F2) in 17,7 % jih je imelo fibrozo z mostiči (F3).
Mechanism: CYP3A4 inhibition by ritonavir and UGT inhibition by paritaprevir, ombitasvir and dasabuvir.
CYP3A4 z ritonavirjem in zavrtje UGT s paritaprevirjem, ombitasvirjem in dasabuvirjem.
HERBAL PRODUCTS St. John's Wort (hypericum perforatum)
ZDRAVILA RASTLINSKEGA IZVORA šentjanževka (Hypericum perforatum)
ANTIHISTAMINES Astemizole
ANTIHISTAMINIKI astemizol terfenadin
Expected: ↓ esomeprazole, lansoprazole
↓ esomeprazol, lansoprazol
Treated subjects (N=631) had a median age of 52 years (range: 18 to 70); 54.5% were male; 5.4% were Black; 15.2% had a history of depression or bipolar disorder; 79.1% had baseline HCV RNA levels of at least 800,000 IU/mL; 15.4% had portal fibrosis (F2) and 8.7% had bridging fibrosis (F3); 67.7% had HCV genotype 1a infection; 32.3% had HCV genotype 1b infection.
Zdravljeni preiskovanci (N = 631) so bili mediano stari 52 let (razpon: od 18 do 70); 54,5 % je bilo moških; 5,4 % je bilo črncev; 15,2 % jih je imelo v anamnezi depresijo ali bipolarno motnjo; 79,1 % jih je imelo izhodiščno koncentracijo HCV RNA vsaj 800.000 i. e./ml; 15,4 % jih je imelo portalno fibrozo (F2) in 8,7 % jih je imelo fibrozo z mostiči (F3); 67,7 % jih je imelo okužbo s HCV genotipa 1a; 32,3 % jih je imelo okužbo s HCV genotipa 1b.
Mechanism: CYP3A4/Pgp inhibition by clarithromyci n and ritonavir.
CYP3A4/P-gp s klaritromicinom in ritonavirjem
Selected treatment emergent laboratory abnormalities
Izbrane laboratorijske nepravilnosti, ki so se pojavile med zdravljenjem
Viekirax 12.5 mg/75 mg/50 mg film-coated tablets ombitasvir/paritaprevir/ritonavir
Viekirax 12,5 mg/75 mg/50 mg filmsko obložene tablete ombitasvir/paritaprevir /ritonavir
Pitavastatin Mechanism: OATP1B inhibition by paritaprevir
OATP1B s paritaprevirjem
Viekirax without dasabuvir duloxetine
Viekirax brez dasabuvirja duloksetin
500 mg single dose
500 mg
Mechanism: CYP3A4/Pgp inhibition by ketoconazole and paritaprevir/ ritonavir/ ombitasvir
CYP3A4/P-gp s ketokonazolom in paritaprevirjem/ ritonavirjem/om bitasvirjem
No subjects with HCV genotype 1b infection experienced on-treatment virologic failure and 2 subjects with HCV genotype 1b infection experienced relapse.
Virološki neuspeh med zdravljenjem se ni pojavil pri nobenem preiskovancu, okuženem s HCV genotipa 1b, recidiv pa se je pojavil pri 2 takšnih preiskovancih.
2 mg single dose
Posamezen odmerek 2 mg
No subjects with HCV genotype 1b infection experienced on-treatment virologic failure and one subject with HCV genotype 1b infection experienced relapse.
Virološki neuspeh med zdravljenjem se ni pojavil pri nobenem preiskovancu, okuženem s HCV genotipa 1b, recidiv pa se je pojavil pri enem takšnem preiskovancu.
SVR12 for genotype 1-infected treatment-naïve subjects in SAPPHIRE-I
SVR12 pri še nezdravljenih preiskovancih, okuženih z genotipom 1, v preskušanju SAPPHIRE-I
Viekirax and dasabuvir with weight-based ribavirin for 12 or 24 weeks
Zdravljenje: Viekirax in dasabuvir z ribavirinom, odvisnim od telesne mase, 12 ali 24 tednov
Anaemia
AMINOSALICILATI
No dose adjustment is necessary for emtricitabine/tenofovir and Viekirax with or without dasabuvir.
Prilagoditev odmerka emtricitabina/tenofov irja in zdravila Viekirax z dasabuvirjem ali brez njega ni potrebna.
NA Reduce pravastatin dose by
Prilagoditev odmerka dolutegravirja ni
ANTIPSYCHOTICS Lurasidone
ANTIPSIHOTIKI lurasidon pimozid kvetiapin
Mechanism: UGT1A1 inhibition by paritaprevir, ombitasvir and dasabuvir.
UGT1A1 s paritaprevirjem, ombitasvirjem in dasabuvirjem
GT1a Arm A: Viekirax and dasabuvir + RBV Arm B: Viekirax and dasabuvir Peginterferon+ribavirin experienced -, without cirrhosis
GT1a Skupina A: Viekirax in dasabuvir+ RBV Skupina B: Viekirax in dasabuvir Že zdravljeni s peginterferonom + ribavirinom, brez ciroze
Efavirenz/ emtricitabine/ tenofovir disoproxil fumarate mg once daily
efavirenz/emtri citabin/dizopro ksiltenofovirat fumarat 600/300/200 m g enkrat na dan
CYP3A4/Pgp inhibition.
CYP3A4/P-gp
Viekirax with weight-based ribavirin for 12 or 16 weeks Subjects had a median age of 56 years (range: 32 to 81); 50% were treatment-naïve, 28% were prior pegIFN/RBV null responders; 10% were prior pegIFN/RBV partial responders, 13% were prior pegIFN/RBV relapsers; 70% were male; 17% were Black; 73% had baseline HCV RNA levels of at least 800,000 IU per mL; 17% had platelet counts of less than 90 x 109 per L; and 4% had albumin less than 3.5 mg per dL.
Preiskovanci so bili mediano stari 56 let (razpon: 32 do 81); 50 % jih še ni bilo zdravljenih, 28 % se jih predhodno ni odzvalo na pegIFN/RBV; 10 % se jih je predhodno delno odzvalo na pegIFN/RBV, 13 % se je predhodno pojavil recidiv s pegIFN/RBV; 70 % je bilo moških; 17 % je bilo črncev; 73 % jih je imelo izhodiščno koncentracijo HCV RNA vsaj 800.000 i.e./ml; 17 % jih je imelo število trombocitov manj kot 90 x 109/l; in 4 % jih je imelo albumin manj kot 3,5 mg/dl.
Viekirax + dasabuvir alprazolam
Viekirax + dasabuvir escitalopram
Mechanism: CYP3A4 induction by phenytoin.
Mehanizem: Indukcija CYP3A4 s fenitoinom
Mechanism: CYP3A4 and/or P-gp inhibition by itraconazole, posaconazole and paritaprevir/ ritonavir/ombi tasvir
CYP3A4 in/ali P-gp z itrakonazolom, posakonazolom in paritaprevirjem/ ritonavirjem/om bitasvirjem
↓ voriconazole ↑ paritaprevir
↓ vorikonazol ↑ paritaprevir
Relapse Otherb a. Confirmed HCV ≥ 25 IU/mL after HCV RNA < 25 IU/mL during treatment, confirmed 1 log10 IU/mL
Celotni SVR12 HCV genotip 1a HCV genotip 1b Izid pri preiskovancih brez SVR12 VN med zdravljenjema Recidiv Drugo b a. Potrjen HCV ≥ 25 i.e./ml po HCV RNA < 25 i.e./ml med zdravljenjem, potrjeno povečanje HCV RNA za 1 log10 i.e./ml od najnižje točke, ali HCV RNA stalno ≥ 25 i.e./ml ob vsaj 6 tednih zdravljenja.
Following a 25 mg single dose of 14C-ombitasvir given alone, unchanged parent drug accounted for 8.9% of total radioactivity in human plasma; a total of 13 metabolites were identified in human plasma.
Po 25-mg enkratnem odmerku 14C-ombitasvirja, uporabljenega samega, je šlo na račun nespremenjenega matičnega zdravila 8,9 %
One subject with HCV genotype 1a infection relapsed post-treatment.
Recidiv po zdravljenju se je pojavil enemu preiskovancu, okuženem s HCV genotipa 1a.
SVR12 for genotype 1b-infected treatment-naïve subjects in PEARL III
SVR12 pri še nezdravljenih preiskovancih, okuženih z genotipom 1b, v preskušanju PEARL III
NAME OF THE MEDICINAL PRODUCT Viekirax 12.5 mg / 75 mg / 50 mg film-coated tablets ombitasvir / paritaprevir / ritonavir
Navodilo za uporabo Viekirax 12,5 mg/75 mg/50 mg filmsko obložene tablete ombitasvir/paritaprevir/ritonavir
In TURQUOISE-I, the SVR12 rates in HCV/HIV-1 co-infected subjects were consistent with SVR12 rates in the phase 3 trials of HCV mono-infected subjects.
V študiji TURQUOISE-I so se deleži SVR12 pri preiskovancih, sočasno okuženih s HCV/HIV-1, skladali z deleži SVR12, ugotovljenimi v preskušanjih 3. faze pri preiskovancih, okuženih samo s HCV. SVR12 je doseglo 7 od 7 preiskovancev, okuženih z genotipom 1b, in 51 od 56 preiskovancev, okuženih z genotipom 1a.
↑ quetiapine ↑ lurasidone
↑ kvetiapin ↑ lurasidon
CYP3A4 inhibition by ritonavir.
Zavrtje CYP3A4 z ritonavirjem
Viekirax is contraindicated in patients with severe hepatic impairment (Child-Pugh C) (see sections 4.3 and 5.2).
Pri bolnikih s hudo okvaro jeter (Child-Pugh C) je zdravilo Viekirax kontraindicirano (glejte poglavji 4.3 in 5.2).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 12.5 mg of ombitasvir, 75 mg of paritaprevir and 50 mg of ritonavir.
Ena filmsko obložena tableta vsebuje 12,5 mg ombitasvirja, 75 mg paritaprevirja in 50 mg ritonavirja.
Mechanism: CYP3A4 inhibition by ritonavir
Mehanizem: Zavrtje CYP3A4 z ritonavirjem
Clinical trials in subjects with genotype 4 chronic hepatitis C PEARL- I- genotype 4, treatment-naïve or pegIFN + RBV experienced without cirrhosis Design:
PEARL- I- genotip 4, še nezdravljeni ali že zdravljeni s kombinacijo pegIFN + RBV, brez ciroze
Expected: ↓ombitasvir ↓ paritaprevir ↓ dasabuvir
Pričakovano: ↓ dasabuvir ↓ ombitasvir ↓ paritaprevir
The pharmacokinetic properties of the combination of Viekirax with dasabuvir have been evaluated in healthy adult subjects and in subjects with chronic hepatitis C. Table 19 shows mean Cmax and AUC of Viekirax 25 mg/150 mg/100 mg once daily with dasabuvir 250 mg twice daily following multiple doses with food in healthy volunteers.
Farmakokinetične lastnosti kombinacije zdravila Viekirax in dasabuvirja so ocenili pri zdravih odraslih in pri bolnikih s kroničnim hepatitisom C. Preglednica 18 prikazuje povprečni Cmax in AUC za zdravilo
SVR12 for genotype 1a-infected treatment-naïve subjects in PEARL IV
SVR12 pri še nezdravljenih preiskovancih, okuženih z genotipom 1a, v preskušanju PEARL IV
Dabigatran etexilate
Pričakovano: ↑ dabigatran eteksilat
HCV genotype 1b
HCV Genotip 1b Viekirax in dasabuvir
↑ paritaprevir ↑ dasabuvir
Pričakovano: ↑ ombitasvir ↑ paritaprevir ↑ dasabuvir
CYP3A4 inhibition by protease inhibitors.
Zdravila, ki zavrejo CYP3A4 in prenašalne proteine
No dose adjustment needed for Viekirax with or without dasabuvir.
Prilagoditev odmerka za zdravilo Viekirax z ali brez dasabuvirja ni potrebna.
No dose adjustment is necessary for raltegravir or Viekirax with or without dasabuvir.
Prilagoditev odmerka raltegravirja ali zdravila Viekirax z dasabuvirjem ali brez njega ni potrebna.
Mechanism: BCRP inhibition by paritaprevir, ritonavir and dasabuvir.
Zavrtje BCRP s paritaprevirjem, ritonavirjem in dasabuvirjem
Expected: ↑ sildenafil
Pričakovano: ↑ amiodaron
Mechanism: Increase in paritaprevir exposures may be due to inhibition of CYP3A/efflu x transporters by lopinavir and higher dose of ritonavir
CYP3A/iztočni h prenašalcev z lopinavirjem in večjim odmerkom ritonavirja
No dose adjustment is necessary for methadone and Viekirax with or without dasabuvir.
Prilagoditev odmerka metadona in zdravila Viekirax z dasabuvirjem ali brez
Viekirax with or without dasabuvir ethinylestradiol
Viekirax z dasabuvirje m ali brez njega etinilestradiol
↑ imatinib
↑ trazodon
Increase in raltegravir exposures may be due to UGT1A1 inhibition by paritaprevir, ombitasvir.
Večja izpostavljenost raltegravirju je morda posledica zavrtja
No dose adjustment of Viekirax with and without dasabuvir is required for patients with mild, moderate or severe renal impairment , or end-stage-renal disease on dialysis (see section 4.2).
Bolnikom, ki imajo blago, zmerno ali hudo okvaro ledvic ali ledvično odpoved in so na dializi, odmerka zdravila Viekirax z dasabuvirjem ali brez njega ni potrebno prilagoditi (glejte poglavje 4.2).
Viekirax and dasabuvir with weight-based ribavirin for 12 weeks
Zdravljenje: Viekirax in dasabuvir z ribavirinom, odvisnim od telesne mase, 12 tednov
20 mg single dose
DIURETIKI furosemid enkraten odmerek 20 mg
Diazepam2 mg single dose
Enkraten odmerek 2 mg
INHALED BETA AGONISTS Salmeterol
AGONISTI ADRENERGIČNIH RECEPTORJEV BETA
(Invented) name
Izmišljeno ime Jakost
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu
Vaccination may interfere with existing sero-epidemiological surveys.
Cepljenje lahko vpliva na obstoječe serološko-epidemiološke študije.
1 x 1 dose 2 x 1 dose 5 x 1 dose 10 x 1 dose
1 x 1 odmerek 2 x 1 odmerek 5 x 1 odmerek 10 x 1 odmerek
Lot {number}
Lot{številka}
Box of 1, 2, 5 or 10 vial(s) of 1 dose.
Škatla z 1, 2, 5 ali 10 vialo(ami) z 1 odmerkom.
Date of first authorisation: 05/08/2011 Date of last renewal: 17/05/2016
Datum pridobitve dovoljenja za promet: 05/08/2011 Datum podaljšanja dovoljenja za promet: 17/05/2016
Store and transport refrigerated (2 °C-8 °C).
Shranjujte in prevažajte v hladilniku (2 °C-8 °C).
• Revaccination: a sufficient degree of protection should be achieved after an annual booster injection with a single dose although this schedule has not been fully validated.
• Revakcinacija: Zadostna zaščita je naj bi bila zagotovljena po revakcinaciji z enim odmerkom cepiva letno, čeprav ta program cepljenja še ni bil dokončno validiran.
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
Odpadne snovi odstranite s prekuhavanjem, sežigom ali potopitvijo v ustreznem dezinfekcijskem sredstvu, katerega uporabo odobrijo pristojni organi.
If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.
Če opazite kakršne koli resne neželene učinke ali druge učinke, ki niso omenjeni v teh navodilih za uporabo, obvestite svojega veterinarja.
A hypersensitivity reaction may occur in rare cases, which may require appropriate symptomatic treatment.
V redkih primerih lahko pride do preobčutljivostne reakcije, ki jo je potrebno ustrezno simptomatično zdraviti.
EU/2/11/129/001 1 x 1 dose EU/2/11/129/002 2 x 1 dose EU/2/11/129/003 5 x 1 dose EU/2/11/129/004 10 x 1 dose
EU/2/11/129/001 1 x 1 odmerek EU/2/11/129/002 2 x 1 odmerek EU/2/11/129/003 5 x 1 odmerek EU/2/11/129/004 10 x 1 odmerek
EXP {month/year} Use immediately after opening
EXP {mesec/leto} Uporabite takoj po prvem odpiranju.
ATC vet code: QI05AX.
Oznaka ATCvet: QI05AX
• Primary vaccination course: first injection from 5 months of age, second injection 4-6 weeks later,
• Primarno cepljenje: prvi odmerek od starosti petih mesecev, drugi odmerek 4 do 6 tednov pozneje.
The safety of the vaccine has been demonstrated in foals from 5 months of age.
Varnost cepiva je bila dokazana pri žrebetih starejših od 5 mesecev.
Sodium chloride Disodium phosphate dihydrate Potassium dihydrogen phosphate Water for injections
Natrijev hidrogenfosfat dihidrat Kalijev dihidrogenfosfat Voda za injekcije
Shelf life of the veterinary medicinal product as packaged for sale: 27 months.
Rok uporabnosti zdravila v pakiranju za prodajo: 27 mesecev.
Any person intending to manufacture, import, possess, sell, supply and use Proteq West Nile must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Vsakdo, ki namerava izdelovati, uvažati oziroma vnašati, posedovati, prodajati, oskrbovati in/ali uporabljati Proteq West Nile, se mora posvetovati s pristojnim organom posamezne države članice o veljavnih programih cepljenja še pred izdelavo, uvozom, posedovanjem, prodajo, oskrbo in/ali uporabo.
The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
SPC, tabela 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo(ES) št. 470/2009.
The manufacture, import, possession, sale, supply and/or use of Proteq West Nile may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Izdelava, uvoz/vnos, posedovanje, prodaja, oskrba in/ali uporaba Proteq West Nile je lahko v državi članici prepovedana na njenem celotnem ozemlju ali delu ozemlja v skladu z nacionalno zakonodajo.
Pharmacotherapeutic group: Immunologicals for equidae, other immunologicals.
Farmakoterapevtska skupina: Imunološka zdravila za konje, druga imunološka zdravila.
Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest France
Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest Francija
However, since the IgM response following vaccination is infrequent, a positive IgM-ELISA test result is a strong indicator of natural infection with West Nile Virus.
Ker pa je IgM odgovor po cepljenju redek, je pozitivna IgM- ELISA pomemben pokazatelj naravne okužbe z virusom West Nile.
Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na zunanji ovojnini, po EXP.
Administer one dose of 1 ml, by intramuscular injection, preferably in the neck region, according to the following schedule:
Injicirajte 1 odmerek (1 ml) intramuskularno, priporočljivo v predel vratu, po naslednjem razporedu:
To stimulate active immunity against West Nile virus.
Cepivo spodbuja aktivno imunost proti virusu West Nile.
Type I glass vial, with a butyl elastomer closure, sealed with an aluminium cap.
Viala iz stekla tipa I z zamaškom iz butilnega elastomera in aluminijasto zaporko.
Onset of immunity: 4 weeks after the first dose of the primary vaccination course.
Nastop imunosti: 4 tedne po prvem odmerku primarnega cepljenja.
In order to achieve full protection, the full vaccination course of two doses must be given.
Za popolno zaščito sta potrebna dva odmerka.
Duration of immunity: 1 year after a full primary vaccination course of two injections.
Čas trajanja imunosti: 1 leto po popolnem primarnem cepljenju (dva odmerka).
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Učinkovina biološkega izvora namenjena vzbujanju aktivne imunosti, ni vključena v Uredbo (ES) št.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions 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).
Each dose of 1 ml contains:
Vsak odmerek (1 ml) vsebuje:
Proteq West Nile suspension for injection for horses
Proteq West Nile suspenzija za injiciranje za konje
The vaccine strain vCP2017 is a recombinant canarypox virus expressing the preM/E genes of West Nile virus.
Sev cepiva vCP2017 je rekombinanten Canarypox virus, ki izraža predM/E gene virusa West Nile.
Pregnancy and lactation: This vaccine can be used during pregnancy and lactation.
Brejost in laktacija: Lahko se uporablja v obdobju brejosti in laktacije.
A slight increase in temperature (max. 1.5 °C) may occur in rare cases for 1 day, exceptionally 2 days.
Redko se lahko pojavi rahlo povišanje temperature (največ 1,5 °C), ki lahko traja 1 dan, izjemoma 2 dni.
INDICATIONS
INDIKACIJA
However, the vaccine has also been shown to be safe in a field study including animals of 2 months of age.
Vendar se je cepivo tudi v terenskem poskusu na žrebetih starih 2 meseca pokazalo za varno.
After inoculation, the virus does not multiply in the horse but expresses the protective proteins.
Po inokulaciji se virus v konjih ne razmnožuje, ampak izraža zaščitne proteine, ki spodbudijo imunost proti virusu West Nile.
Proteq West Nile suspension for injection
Proteq West Nile suspenzija za injiciranje
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE
If infection is suspected as a result of a positive IgM response, additional testing would need to be conducted to conclusively determine whether the animal was infected or vaccinated.
Če je sum na okužbo postavljen na podlagi pozitivnega IgM odziva, je priporočljivo dodatno dokazovanje, ali je prišlo do naravne okužbe ali je odziv posledica cepljenja.
Active immunisation of horses from 5 months of age against West Nile disease by reducing the number of viraemic horses.
Aktivna imunizacija konj, starih 5 mesecev ali več proti bolezni West Nile za zmanjšanje števila viremičnih konjev oziroma za zmanjšanje resnosti in trajanja kliničnih znakov, če so ti že prisotni.
Active substance:
Zdravilni učinkovini:
DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
ODMEREK ZA POSAMEZNE ŽIVALSKE VRSTE TER NAČIN UPORABE IN
Apathy, usually resolving within two days, and reduced appetite may be observed in rare cases the day after vaccination.
V redkih primerih se lahko dan po cepljenju pojavita apatičnosti in zmanjšan tek.
A transient swelling (max. diameter 5 cm) which resolves within 4 days may appear commonly at the injection site.
Na mestu injiciranja se lahko pogosto pojavi prehodna oteklina (s premerom največ 5 cm), ki izgine v 4 dneh.
Pain and local hyperthermia can occur in rare cases.
V redkih primerih se lahko pojavita bolečina in lokalno povišana temperatura.