natgillin/translations-raw huggingface dataset:
Table 3: Adverse drug reactions to INCIVO (taken in combination with peginterferon alfa and ribavirin) in HCV-infected patients in clinical trials a and post-marketing Adverse Drug Reactions INCIVO, peginterferon alfa, and ribavirin combination therapy oral candidiasis anaemia thrombocytopenia b, lymphopenia hypothyroidism hyperuricaemia b, hypokalaemia gout dysgeusia, syncope
Neželeni učinki zdravil INCIVO, peginterferon alfa in ribavirin v kombinirani terapiji kandidoza v ustih anemija trombocitopenija b, limfopenija hipotireoza hiperurikemija b, hipokaliemija protin, disgevzija, sinkopa retinopatija navzea, driska, bruhanje, hemoroidi, proktalgija analni pruritus, krvavitev iz rektuma, analna fisura proktitis, pankreatitis hiperbilirubinemija pruritus, izpuščaj ekcem, otekanje obraza, eksfoliativni izpuščaj medikamentozni izpuščaj z eozinofilijo in sistemskimi simptomi (DRESS), urtikarija SJS, TEN, multiformni eritem povečana koncentracija kreatinina v krvi b,
alfentanil, fentanyl to treat pain (analgesics) or used during surgery to induce sleep digoxin, intravenous lidocaine to treat certain heart disorders such as abnormal heart beat (antiarrhythmics)
Namen zdravila: za zdravljenje določenih srčnih bolezni, na primer motenj srčnega ritma (antiaritmiki) za zdravljenje bolečine (analgetiki) ali za uvod v anestezijo med kirurškimi posegi za zdravljenje določenih srčnih bolezni, na primer motenj srčnega ritma (antiaritmiki)
Refer to their respective Summary of Product Characteristics for their associated adverse reactions.
Neželeni učinki obeh zdravil so navedeni v ustreznih Povzetkih glavnih značilnosti zdravila.
T12/PR: INCIVO for 12 weeks with peginterferon alfa-2a and ribavirin for 24 or 48 weeks; Pbo/PR: placebo for 12 weeks with peginterferon alfa-2a and ribavirin for 48 weeks
T12/PR: Jemanje zdravila INCIVO 12 tednov s peginterferonom alfa-2a in ribavirinom v času 24 ali 48 tednov; Pbo/PR: Jemanje placeba 12 tednov s peginterferonom alfa-2a in ribavirinom v času 48 tednov
Interruption of ribavirin may be required sooner if the rash worsens despite discontinuation of telaprevir.
Če se izpuščaj, kljub ukinitvi zdravila INCIVO, poslabša bo lahko zdravljenje z ribavirinom potrebno prekiniti že prej.
Refer to the Summary of Product Characteristics for ribavirin for information regarding dose reduction and/or discontinuation of ribavirin.
Za navodila za zmanjšanje odmerka in/ali ukinitev ribavirina glejte Povzetek glavnih značilnosti zdravila z ribavirinom.
Eye disorders uncommon retinopathy
Bolniki, ki niso prejeli protiretrovirusnega
↓ telaprevir
Izdelovalec
Co-administration with phenytoin is contraindicated.
Sočasna uporaba s fenitoinom je kontraindicirana.
Refer also to the Summary of Product Characteristics for ribavirin for patients with CrCl < 50 ml/min.
Za podatke o bolnikih s CrCl < 50 ml/min glejte tudi Povzetek glavnih značilnosti zdravila ribavirin.
Prior non-responders includes prior partial responders and prior null responders.
Bolniki, ki se na predhodno zdravljenje niso odzvali (delni odziv, brez odziva).
Medicinal products by therapeutic areas
Učinkovitost zdravila pri predhodno zdravljenih odraslih
↓ ethinylestradiol AUC 0.72 (0.69-0.75) Cmax 0.74 (0.68-0.80) Cmin 0.67 (0.63-0.71) ↔ norethindrone AUC 0.89 (0.86-0.93) Cmax 0.85 (0.81-0.89) Cmin 0.94 (0.87-1.00) mechanism unknown
↓ telaprevirja AUC 0,68 (0,58-0,79) Cmax 0,79 (0,70-0,90) Cmin 0,53 (0,44-0,65) ↔ karbamazepina AUC 1,10 (0,99-1,23) Cmax 1,09 (0,98-1,21) Cmin 1,10 (0,97-1,24) indukcija CYP3A s karbamazepinom in
Baseline liver fibrosis No fibrosis or minimal fibrosis
Ni fibroze ali minimalna fibroza oziroma
Telaprevir did not have any teratogenic potential in rat or mouse.
Pri podganah in miših telaprevir ni imel teratogenih učinkov.
It is not recommended to co-administer lopinavir/ritonavir and telaprevir (see section 4.4).
Sočasna uporaba lopinavirja/ritonavirja in telaprevirja ni priporočljiva (glejte poglavje 4.4).
It is not recommended to co-administer darunavir/ritonavir and telaprevir (see section 4.4).
Sočasna uporaba darunavirja/ritonavirja in telaprevirja ni priporočljiva (glejte poglavje 4.4).
See also the package leaflets for peginterferon alfa and ribavirin.
Za dodatne podatke glejte navodili za uporabo peginterferona alfa in ribavirina.
bullous eruption, DRESS, SJS/TEN, acute
- otekanje obraza, otekanje rok in/ali nog (edem)
The 1,088 enrolled patients had a median age of 49 years (range: 18 to 69); 58% of the patients were male; 23% had a body mass index ≥ 30 kg/m2; 9% were Black; 11% were Hispanic or Latino; 77% had baseline HCV RNA levels ≥ 800,000 IU/ml; 15% had bridging fibrosis; 6% had cirrhosis; 59% had HCV genotype 1a; and 40% had HCV genotype 1b.
Pri 1.088 vključenih bolnikih je bila mediana vrednost starosti 49 let (razpon: od 18 do 69 let); 58% bolnikov je bilo moških, 23% je imelo indeks telesne mase ≥ 30 kg/m2, 9% je bilo črncev in 11% je bilo španskega ali latinskoameriškega rodu.
Refer to section 4.5 for established and other potentially significant drug-drug interactions.
Za dokazane in druge, morda pomembne interakcije z drugimi zdravili glejte poglavje 4.5.
Study 106 and Study 107
Preglednica 7: stopnje odziva: študija 108
Refer to the Summary of Product Characteristics for ribavirin and peginterferon alpha for additional
Za dodatne podatke preberite tudi Povzetek glavnih značilnosti zdravila ribavirin in peginterferon alfa.
Dose modification of INCIVO is not required when administered to hepatitis C patients with mild hepatic impairment (Child-Pugh A, score 5-6).
Pri bolnikih s hepatitisom C z blago jetrno okvaro (razred A po Child-Pughu, ocena 5-6) prilagoditev odmerka zdravila INCIVO ni potrebna.
Duration of treatment - Treatment-naïve adults and prior treatment relapsers Treatment with INCIVO must be initiated in combination with peginterferon alfa and ribavirin and administered for 12 weeks (see figure 1).
Trajanje zdravljenja - nezdravljeni odrasli in bolniki, ki so po predhodnem zdravljenju ponovno zboleli Zdravljenje z zdravilom INCIVO je treba uvesti v kombinaciji s peginterferonom alfa in ribavirinom.
The 74 enrolled patients had a median age of 56 years (range: 43 to 68 years); 91.9% of the patients were male; 24.3% had a body mass index ≥ 30 kg/m2; 1.4% were Black; 95.9% had baseline HCV
Skupaj 540 vključenih bolnikov je imelo mediano starost 51 let (razpon: od 19 do 70 let), 60% bolnikov je bilo moškega spola, 32% je imelo indeks telesne mase ≥ 30 kg/m2, 14% je bilo črncev,
dihydroergotamine, ergonovine, ergotamine,
dihidroergotamin, ergonovin, ergotamin, metilergonovin za zdravljenje migrene in glavobola (alkaloidi ergot)
a Grade ≥ 2) that represent a worsening from baseline and are considered adverse drug reactions in HCV-infected patients treated with INCIVO combination treatment from the pooled data from the placebo-controlled
a) iz združenih podatkov s placebo nadzorovanih preskušanj faze II in III, ki predstavljajo poslabšanje od začetka zdravljenja in so obravnavani kot neželeni učinki pri bolnikih, okuženih s HCV, ki se zdravijo s kombinacijo z zdravilom INCIVO
See table 1 for Guidelines for Discontinuation of INCIVO, Peginterferon Alfa, and Ribavirin Treatment.
Za smernice o ukinitvi zdravljenja z zdravilom INCIVO, peginterferonom alfa in ribavirinom glejte preglednico 1.
3) being treated with efavirenz or atazanavir/ritonavir in combination with tenofovir disoproxil fumarate and emtricitabine or lamivudine.
3) ali so imeli stabilno, nadzorovano okužbo s HIV (< 50 kopij RNK HIV/ml, število celic CD4 ≥ 300 celic/mm3) in so se zdravili z efavirenzom ali s shemo atazanavir/ritonavir v kombinaciji s dizoproksiltenofovirat fumaratom in emtricitabinom ali lamivudinom.
Table 12 shows SVR rates by extent of liver fibrosis.
Preglednica 12: stopnje trajnega virološkega odziva glede na obseg jetrne fibroze na začetku
If your treatment is not working, your doctor may stop your medicines.
Če bo ugotovil, da zdravljenje nima učinka, ga bo lahko prekinil.
INCIVO must be administered with peginterferon alfa and ribavirin.
Zdravilo INCIVO je treba uporabljati skupaj s peginterferonom alfa in ribavirinom.
There are no clinical data on the use of INCIVO in patients on haemodialysis.
O uporabi zdravila INCIVO pri bolnikih, ki se zdravijo s hemodializo, ni kliničnih podatkov.
INCIVO must be taken in combination with peginterferon alfa and ribavirin.
Predpisujete ga lahko samo v kombinaciji s peginterferonom alfa in ribavirinom.
T12/P(2a)R48: INCIVO for 12 weeks in combination with peginterferon alfa-2a and ribavirin for 24 or 48 weeks T12/P(2b)R48: INCIVO for 12 weeks in combination with peginterferon alfa-2b and ribavirin for 24 or 48 weeks 95% confidence interval for the difference was (-10.8, 12.1) Denominator was the number of patients with undetectable HCV RNA (target not detected) at end of treatment
T12/PR24: Jemanje zdravila INCIVO 12 tednov s peginterferonom alfa-2a in ribavirinom v času 24 tednov; T12/PR48: jemanje zdravila INCIVO 12 tednov s peginterferonom alfa-2a in ribavirinom v času 48 tednov; Postavka »vsi bolniki« zajema 322 bolnikov z nezaznavno HCV RNK (nezaznaven analit) v 4. in 12. tednu in 218 drugih bolnikov, ki so bili zdravljeni v študiji (118 takih, ki niso imeli nemerljive HCV RNK (nezaznaven analit) v 4. tednu in v 12. tednu, in 100 takih, ki so zapustili študijo pred 20. tednom, ko je bila opravljena randomizacija).
It is important to stay hydrated with fluids during INCIVO combination treatment.
Med kombiniranim zdravljenjem z zdravilom INCIVO je pomembna zadostna hidracija.
Caution is warranted and clinical monitoring is recommended when co-administered with INCIVO.
Potrebna je previdnost in pri sočasni uporabi antibiotikov z zdravilom INCIVO je priporočljivo klinično spremljanje bolnika.
The 540 enrolled patients had a median age of 51 years (range: 19 to 70); 60% of the patients were male; 32% had a body mass index ≥ 30 kg/m2; 14% were Black; 10% were Hispanic or Latino; 82% had baseline HCV RNA levels > 800,000 IU/ml; 16% had bridging fibrosis; 11% had cirrhosis; 72% had HCV genotype 1a; and 27% had HCV genotype 1b.
10% je bilo španskega ali latinskoameriškega rodu, 82% je imelo začetno vrednost HCV RNK > 800.000 i.e./ml, 16% je imelo mostno fibrozo, 11% je imelo cirozo, 72% je imelo HCV genotip 1a
Interactions between telaprevir and HIV antiretroviral agents are frequent, and the recommendations in table 2, section 4.5, should be carefully followed.
Medsebojna delovanja telaprevirja s protiretrovirusnimi zdravili za zdravljenje okužbe s HIV so pogosta.
SVR in patients who did not have undetectable HCV RNA (target not detected) at weeks 4
SVR pri bolnikih, ki niso dosegli eRVR Koncentracija HCV RNK < 25 i.e./ml ob koncu
SVR rates for patients with or without cirrhosis Patients without cirrhosis 65.5% (38/58)
Stopnje SVR pri bolnikih s cirozo ali brez ciroze bolniki s cirozo bolniki brez ciroze
Increases in serum uric acid occur very commonly during treatment with INCIVO in combination with peginterferon alfa and ribavirin.
Med zdravljenjem z zdravilom INCIVO v kombinaciji s peginterferonom alfa in ribavirinom se zelo pogosto pojavlja zvečanje koncentracij sečne kisline v serumu.
Gastrointestinal disorders very common nausea, diarrhoea, vomiting, haemorrhoids, proctalgia common anal pruritus, rectal haemorrhage, anal fissure uncommon proctitis, pancreatitis
simptomi, napredujoč, hud izpuščaj, sum na ali diagnosticiran bulozni izpuščaj, sindrom
Talk to your doctor or pharmacist before taking INCIVO.
Pred začetkom jemanja zdravila INCIVO se posvetujte z zdravnikom ali farmacevtom.
The 662 enrolled patients had a median age of 51 years (range: 21 to 70); 70% of the patients were male; 26% had a body mass index ≥ 30 kg/m2; 5% were Black; 11% were Hispanic or Latino; 89% had baseline HCV RNA levels > 800,000 IU/ml; 22% had bridging fibrosis; 26% had cirrhosis; 54% had HCV genotype 1a; and 46% had HCV genotype 1b.
Skupaj 662 vključenih bolnikov je imelo mediano starost 51 let (razpon: od 21 do 70 let), 70% bolnikov je bilo moškega spola, 26% je imelo indeks telesne mase ≥ 30 kg/m2, 5% je bilo črncev in 11% je bilo španskega ali latinskoameriškega rodu.
You must read the package leaflets for peginterferon alfa and ribavirin for additional information.
Za dodatne podatke preberite navodili za uporabo peginterferona alfa in ribavirina.
Effect on unbound telaprevir concentrations is unknown (see sections 4.2 and 4.4).
Učinek na koncentracije nevezanega telaprevirja ni znan (glejte
There is limited pharmacokinetic data on the use of INCIVO in HCV patients aged ≥ 65 years and no data in subjects > 70 years of age.
Podatkov o uporabi zdravila INCIVO pri bolnikih starih > 70 let ni.
See the package leaflets for peginterferon alfa and ribavirin for a list of their contraindications (e.g. pregnancy precautions for men and women) since INCIVO must be used in combination with peginterferon alfa and ribavirin.
Zdravilo INCIVO morate uporabljati skupaj s peginterferonom alfa in ribavirinom, zato glejte tudi seznam kontraindikacij (npr. preprečevanje nosečnosti) v navodilih za uporabo teh dveh zdravil.
Contact your doctor immediately if you get a skin rash.
Če se pri vas pojavi kožni izpuščaj, se takoj obrnite na svojega zdravnika.
Exposure to telaprevir is higher during co-administration of peginterferon alfa and ribavirin than after administration of telaprevir alone.
Stopnja izpostavljenosti bolnika telaprevirju je večja med sočasnim jemanjem peginterferona alfa in ribavirina
Refer also to the Summary of Product Characteristics for ribavirin for patients with CrCL < 50 ml/min
Pri bolnikih s CrCl < 50 ml/min glejte tudi Povzetek glavnih značilnosti zdravila ribavirin (glejte tudi
Hepatobiliary disorders common hyperbilirubinaemia
ANTIKONVULZIVI karbamazepin*
SVR in patients with undetectable HCV RNA (target not detected) at weeks 4 and 12
Preglednica 9: stopnje odziva: študija 111 Bolniki z nezaznavno HCV RNK (nezaznaven analit) v 4. in 12. tednu
PDE-5 INHIBITORS sildenafil tadalafil vardenafil
IMUNOSUPRESIVI ciklosporin* takrolimus* sirolimus
Furthermore, high rates of anaemia have been seen when using INCIVO with peginterferon and ribavirin in patients with these characteristics.
Pri teh bolnikih so ob uporabi zdravila INCIVO v kombinaciji s peginterferonom in ribavirinom opazili tudi večjo pogostnost anemije.
This medicine contains 2.3 mg sodium per tablet, which should be taken into consideration by patients on a controlled sodium diet. Tell your doctor if you have to take care of your salt intake and follow a
Zdravniku povejte, če morate paziti na vnos soli ali ste na dieti z nadzorovano količino
Concurrent administration of salmeterol and telaprevir is not recommended.
INHALACIJSKI AGONISTI ADRENERGIČNIH RECEPTORJEV BETA Sočasna uporaba salmeterola in telaprevirja ni priporočljiva.
Treatment Outcome Treatment-Naïve Patients N = 64 % (n/N)
Zdravljeni bolniki po podskupinah Bolniki s ponovitvijo bolezni N = 29 % (n/N)
to treat some stomach conditions (gastrointestinal motility agents)
cisaprid za zdravljenje nekaterih želodčnih bolezni (zdravila za urejanje gibljivosti prebavil)
® TaqMan
Izpuščaj
Manufacturer Janssen-Cilag SpA, Via C. Janssen,
Janssen-Cilag SpA, Via C. Janssen, 04010 Borgo San Michele, Latina, Italija
Follow usual aseptic procedures.
Upoštevajte običajna merila aseptičnega dajanja.
Following the second vaccination swelling may persist for at least 35 days.
Po drugem cepljenju lahko takšna oteklina traja najmanj 35 dni.
According to Article 71 of Directive 2001/82/EC as amended, Member States prohibit or may prohibit the import, sale, supply and/or use of the veterinary medicinal product on the whole or part of their a) the administration of the veterinary medicinal product to animals will interfere with the implementation of a national programme for the diagnosis, control and eradication of animal disease, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory.
Skladno z 71. členom Direktive 2001/82/ES Evropskega parlamenta in Sveta, države članice prepovejo ali lahko prepovejo uvoz, prodajo, oskrbo in/ali uporabo zdravila za uporabo v veterinarski medicini na svojem celotnem ozemlju ali delu ozemlja, če se ugotovi da: a) bi uporaba zdravila za uporabo v veterinarski medicini ovirala izvajanje nacionalnih programov za diagnozo, nadzor ali zatiranje živalskih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti pri živih živalih ali živilih ali drugih proizvodih, pridobljenih iz b) bolezen, za katero se z zdravilom za uporabo v veterinarski medicini pridobi imunost, na
One dose of 0.5 ml should be given at 10 to 14 weeks of age.
En odmerek po 0,5 ml dajemo pri starosti 10 do 14 tednov.
Triethanolamine (at doses up to 0.25 mg/kg bw) is considered not within the scope of Council
Trietanolamin (v odmerkih do 0,25 mg/kg telesne mase) ni vključen v Uredbo Sveta (EGS) št.
Intervet International B.V. Wim de Körverstraat 35 5831AN Boxmeer The Netherlands
Wim de Körverstraat 35 5831AN Boxmeer Nizozemska
Swelling was very common.
Oteklina je bila zelo pogosta.
EU/2/09/093/001 EU/2/09/093/002
EU/0/00/000/000
Store and transport refrigerated (2ºC - 8°C).
Shranjujte in prevažajte v hladilniku (2 C - 8 C).
Accidental injection is dangerous - read package leaflet before use.
Nenamerno injiciranje je nevarno - pred uporabo preberite navodilo za uporabo.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
Če opazite kakršne koli resne stranske učinke ali druge učinke, ki niso omenjeni v teh navodilih za
Vaccination may result in moderate swelling of the breast tissue which will resolve within 30 days.
Cepljenje lahko povzroči zmerno oteklino tkiva na prsih, ki v 30 dneh mine.
Pharmacotherapeutic group: Immunologicals for aves, ATC vet code: QI01AB08
Farmakoterapevtska skupina: imunološka zdravila za ptice, oznaka ATCvet: QI01AB08
Annex II of Council Regulation (EEC)
Dodatek II Uredbe Sveta (EGS) št. 2377/90
The second dose should be administered no later than 6 weeks before the onset of lay.
Drugega odmerka ne smemo dati pozneje kot 6 tednov pred začetkom obdobja nesnosti.
Do not use after the expiry date stated on the carton.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na škatli.
Vaccine against necrotic enteritis
Cepivo proti nekrotičnemu enteritisu
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Za vse nadaljnje informacije o tem zdravilu se obrnite na krajevno predstavništvo imetnika dovoljenja
No systemic reactions to vaccination were seen following intramuscular vaccination.
Po intramuskularnem cepljenju niso bile opažene nikakršne sistemske spremembe.
Clostridium perfringens Type A alpha toxoid Not less than 6.8 IU *
Clostridium perfringens tipa A, toksoid alfa ne manj kot 6,8 i.e.*
Thiomersal
KARENCA
Netvax emulsion for injection for chickens
Netvax, emulzija za injiciranje za piščance
If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
Če vam je bil ta proizvod nenamerno injiciran, se takoj posvetujte z zdravnikom, čeprav je bila injicirana le majhna količina, in mu pokažite navodilo za uporabo.
Clostridium perfringens Type A alpha toxoid: ≥ 6.8 IU*
Clostridium perfringens tipa A, toksoid alfa: ≥ 6,8 i.e.*
The onset of passive transfer of immunity: 6 weeks following completion of the vaccination procedure
Prenos pasivne imunosti: 6 tednov po končanem postopku cepljenja.
The vaccine is safe for use in laying and breeding birds.
Uporaba cepiva je varna pri pticah v obdobju nesnosti in pri vzrejnih pticah.
After administration of a double dose, local reactions may increase slightly.
Po dajanju dvojnega odmerka se lahko nekoliko povečajo lokalne reakcije (glejte poglavje 4.6).
Name and address of the manufacturer of the biological active substance(s)
Ime in naslov izdelovalca(izdelovalcev) biološke zdravilne učinkovine (zdravilnih učinkovin)
A second dose of 0.5 ml should be administered 4 to 10 weeks after the first vaccination.
Drugi odmerek po 0,5 ml dajemo 4 do 10 tednov po prvem.
The duration of passive transfer of immunity: 51 weeks following completion of the vaccination procedure
Trajanje prenesene pasivne imunosti: 51 tednov po končanem postopku cepljenja.
Shelf-life after first opening the immediate packaging: 8 hours
Rok uporabnosti po prvem odpiranju vsebnika: 8 ur.
Special precautions to be taken by the person administering the veterinary medicinal product to
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo
Pack Sizes
Velikost pakiranja
500ml high density polyethylene (HDPE) flexible bottle closed with a chlorobutyl rubber closure held in place with an aluminium seal with centre hole.
Steklenička iz polietilena velike gostote (HDPE) s klorobutilnim gumijastim zamaškom in aluminijasto zaporko z odprtino v sredini.
Vaccinate chickens by the intramuscular route into the breast.
Piščance cepite intramuskularno v prsno mišico.
Syringes and needles must be sterile before use.
Uporabljajte sterilne brizge in igle.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
A. IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROSTITEV SERIJE
To reduce mortality and the incidence and severity of lesions caused by Clostridium perfringens Type A induced necrotic enteritis.
Za zmanjšanje pogina ter pojavnosti in resnosti okvar pri nekrotičnem enteritisu, ki jih povzroča bakterija Clostridium perfringens tipa A. Učinkovitost je dokazana z izzivnim preizkusom pri piščancih približno tri tedne po izvalitvi.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR
<IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN>IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROŠČANJE
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNEGA ZA SPROSTITEV SERIJE V EGP, ČE STA RAZLIČNA
For the active immunization of chickens to provide passive immunisation against necrotic enteritis to their progeny, during the laying period.
Za aktivno imunizacijo piščancev proti nekrotičnemu enteritisu v času nesnosti in prenos pasivne
MINIMUM PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING UNITS
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
Pack sizes:
Namenjeno uporabniku:
To stimulate active immunity in chickens, in order to provide passive protection to the progeny against Clostridium perfringens Type A induced necrotic enteritis.
Za aktivno imunizacijo piščancev proti nekrotičnemu enteritisu, ki ga povzroča bakterija Clostridium perfringens tipa A, v času nesnosti in prenos pasivne zaščite na njihove potomce.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO
CONDITIONS OR RESTRICTIONS OF THE MARKETING
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
B POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE
Keep out of the reach and sight of children.
Shranjujte nedosegljivo otrokom
This summary was last updated in 08-2011.
Povzetek je bil nazadnje posodobljen 08-2011.
The European Commission granted a marketing authorisation valid throughout the European Union for Savene on 28 July 2006.
Evropska komisija je dovoljenje za promet z zdravilom Savene, veljavno po vsej Evropski uniji, odobrila dne 28. julija 2006.
Savene dexrazoxane
Savene deksrazoksan