natgillin/translations-raw huggingface dataset:
Study MMY3004 demonstrated an improvement in PFS in the DVd arm as compared to the Vd arm; the median PFS had not been reached in the DVd arm and was 7.2 months in the Vd arm (HR [95% CI]: 0.39 [0.28, 0.53]; p-value<0.0001), representing a 61% reduction in the risk of disease progression or death for patients treated with DVd versus Vd.
Mediana PFS v skupini DVd ni bila dosežena, v skupini Vd pa je znašala 7,2 meseca (razmerje ogroženosti [95-odstotni IZ]: 0,39 [0,28; 0,53]; vrednostp<0,0001), kar predstavlja 61% zmanjšanje tveganja za napredovanje bolezni ali za smrt pri bolnikih, zdravljenih z DVd v primerjavi z Vd (glejte sliko 4).
Concentrate for solution for infusion.
Razmislite lahko tudi o uporabi genotipizacije.
Weeks 1, 2, 4 and 5 for the first 6-week cycle (Cycle 1; 8 doses), followed by once weekly administrations at Weeks 1, 2, 4 and 5 for eight more 6-week cycles (Cycles 2-9; 4 doses per cycle).
Bortezomib so prejemali s subkutanimi injekcijami v odmerku 1,3 mg/m2 telesne površine dvakrat na teden v 1., 2., 4. in 5. tednu prvega 6-tedenskega kroga zdravljenja (1. krog; 8 odmerkov), nato pa so ga prejemali enkrat na teden v 1., 2., 4. in 5. tednu nadaljnjih osem 6-tedenskih krogov zdravljenja (2. do 9. krog; 4 odmerki na krog).
No clinically important differences in the exposure to daratumumab were observed between patients with hepatic impairment and those with normal hepatic function.
Med bolniki z okvaro jeter in tistimi z normalno jetrno funkcijo niso opažali klinično pomembnih razlik v izpostavljenosti daratumumabu.
• inflamed pancreas
• okužba sečil
First dose of the every-3-week dosing schedule is given at Week 7 First dose of the every-4-week dosing schedule is given at Week 55
od 55. tedna dalje do napredovanja bolezni b vsak četrti teden prvi odmerek po razporedu enkrat na 3 tedne prejme bolnik v 7. tednu prvi odmerek po razporedu enkrat na 4 tedne prejme bolnik v 55. tednu
Results of an updated PFS analysis approximately 4 months after the original clinical cutoff, continued to show an improvement in PFS for patients in the D-VMP arm compared with the VMP arm.
Rezultati študije MMY3004 so pokazali izboljšano preživetje brez napredovanja bolezni (PFS) v skupini DVd v primerjavi s skupino Vd.
Patients should be typed and screened prior to starting daratumumab treatment.
Pred začetkom zdravljenja z daratumumabom je treba opraviti tipizacijo in presejanje krvi.
Study MMY3004, an open-label, randomised, active-controlled Phase III trial, compared treatment with DARZALEX 16 mg/kg in combination with bortezomib and dexamethasone (DVd), to treatment with bortezomib and dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma who had received at least one prior therapy.
V študiji MMY3004, odprti, randomizirani, z učinkovino nadzorovani študiji faze III, so primerjali zdravljenje z zdravilom DARZALEX 16 mg/kg v kombinaciji z bortezomibom in deksametazonom (DVd) z zdravljenjem z bortezomibom in deksametazonom (Vd) pri bolnikih, ki so imeli diseminirani plazmocitom in so že prejeli najmanj eno predhodno zdravljenje.
Dyspnoea Pulmonary oedema
• vnetje trebušne slinavke
Gastrointestinal disorders Diarrhoea
Profilaksa reaktivacije virusa herpes zoster
Maximum rate
Celokupna stopnja odziva
Do not use if opaque particles, discolouration or other foreign particles are present.
Če je barva raztopine spremenjena ali vsebuje neprozorne ali tuje delce, je ne smete uporabiti.
Odds ratio with 95% CI p-value
b razmerje obetov (OR) s 95-odstotnim IZ Vrednost-p
Your doctor may decide not to use DARZALEX if you have a strong infusion reaction.
Če doživite hudo infuzijsko reakcijo, se vaš zdravnik lahko odloči, da vam ne bo več dajal zdravila DARZALEX.
Glacial acetic acid Mannitol (E421) Polysorbate 20
6.1 Seznam pomožnih snovi koncentrirana ocetna kislina manitol (E421) polisorbat 20 natrijev acetat trihidrat natrijev klorid voda za injekcije
Less than 1% of patients had a Grade 3/4 infusion-related reaction with the Week 2 or subsequent infusions.
Pri infuziji v 2. tednu ali nadaljnjih infuzijah se je infuzijska reakcija 3./4.
DARZALEX infusion should be interrupted for IRRs of any severity and medical management/supportive treatment for IRRs should be instituted as needed.
Ob pojavu infuzijske reakcije je treba ne glede na njeno intenzivnost prekiniti infundiranje zdravila DARZALEX in po potrebi uvesti ustrezno podporno zdravljenje.
Dilution volume
• zvišana telesna temperatura
DARZALEX therapy should be discontinued immediately and permanently (see sections 4.2 and 4.3).
Zdravljenje z zdravilom DARZALEX je treba takoj in trajno ukiniti.
The primary analysis of PFS in Study MMY3007 showed an improvement in the D-VMP arm as compared to the VMP arm; the median PFS had not been reached in the D-VMP arm and was 18.1 months in the VMP arm (HR=0.5; 95% CI: 0.38, 0.65; p<0.0001), representing 50% reduction in the risk of disease progression or death in patients treated with D-VMP.
Primarna analiza PFS v študiji MMY3007 je pokazala izboljšanje preživetja v skupini D-VMP v primerjavi s skupino VMP; mediana PFS v skupini D-VMP ni bila dosežena, v skupini VMP pa je bila 18,1 meseca (razmerje ogroženosti=0,5; 95-odstotni IZ: 0,38, 0,65; p<0,0001), kar predstavlja 50-odstotno zmanjšanje tveganja za napredovanje bolezni ali smrt pri bolnikih, zdravljenih z D-VMP. Tudi rezultati dopolnjene analize PFS približno 4 mesece po prvotnem presečnem datumu so pokazali izboljšanje preživetja brez napredovanja bolezni v skupini D-VMP v primerjavi s skupino VMP. Mediana PFS v skupini D-VMP ni bila dosežena, v skupini VMP pa je bila 19,3 meseca (razmerje ogroženosti=0,46; 95-odstotni IZ: 0,36, 0,60; p<0,0001).
leukopenia)
(trombocitopenija)
Additional background regimen specific corticosteroids (e.g. prednisone) should not be taken on DARZALEX infusion days when patients have received dexamethasone as a pre-medication.
Na tiste dni, ko bolnik prejme infuzijo zdravila DARZALEX in deksametazon kot premedikacijo, ne sme v okviru osnovne sheme zdravljenja dodatno prejeti še kortikosteroida (npr. prednizona).
Median Duration of Response [months (95% CI)]
stopnja dosežene klinične koristi (ORR+MR) [n (%)] mediano trajanje odziva [meseci (95-odstotni IZ)]
Leukopenia
Hrvatska
Urinary tract infection Common Influenza
Žilne bolezni hipertenzija zelo pogosti
Figure 4: Kaplan-Meier Curve of PFS in Study MMY3004
Slika 4: Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni v študiji MMY3004
DARZALEX is given as an infusion (drip) into a vein.
Zdravilo DARZALEX boste prejeli v veno z infuzijo.
o All patients should be typed and screened prior to start treatment with daratumumab; alternatively, phenotyping may also be considered; o Daratumumab-mediated positive indirect Coombs test (interfering with cross-matching of blood) may persist for up to 6 months after the last product's infusion, therefore, the HCP should advise the patient to carry the Patient Alert Card until 6 months after the treatment has ended; o Daratumumab bound to Red Blood Cells (RBCs) may mask the detection of antibodies to minor antigens in the patient's serum; o The determination of a patient's ABO and Rh blood type are not impacted; o The interference mitigation methods include treating reagent RBCs with dithiothreitol (DTT) to disrupt daratumumab binding or other locally validated methods.
DRd=daratumumab-lenalidomid-deksametazon; Rd=lenalidomid-deksametazon; MRD=minimalna preostala bolezen (minimal residual disease); IZ=interval zaupanja; NMO=vrednosti ni mogoče oceniti vrednost-p pri testu hi-kvadrat po Cochran Mantel-Haenszelu na osnovi populacije z namenom zdravljenja (Intent-to-treat) in pražne vrednosti 10 uporabljena je ocena skupnega razmerja obetov s testom hi-kvadrat: razmerje obetov >1 pomeni prednost zdravljenja z DRd vrednost- p na osnovi razmerja verjetnosti pri testu hi-kvadrat
Adopted at the 3-6 September 2018 PRAC
Sprejeto na seji odbora PRAC med 3. in 6. septembrom 2018
Most cases occurred within 2 months of alemtuzumab dosing.
Večina primerov se je pojavila v dveh mesecih po odmerku alemtuzumaba.
- if you have had skin cancer or if you develop an unexpected skin lesion during the treatment.
- če ste imeli kožnega raka ali če se vam med zdravljenjem pojavijo nepričakovane kožne spremembe.
A cumulative doseresponse relationship was demonstrated with an adjusted OR 2.1 (95% CI: 1.7-2.6) increasing to OR 3.9 (3.0-4.9) for high use (~25,000 mg) and OR 7.7 (5.7-10.5) for the highest cumulative dose (~100,000 mg) (see also section 4.4).
Razmerje med kumulativnim odmerkom in odzivom so dokazali s tem, da se je prilagojeni OR z 2,1 (95-odstotni IZ: 1,7-2,6), zvišal na 3,9 (3,0-4,9) pri velikih odmerkih (~ 25.000 mg) in celo na 7,7 (5,7-10,5) pri največjih kumulativnih odmerkih (~ 100.000 mg) (glejte tudi poglavje 4.4).
2 Ciprofloxacin; flumequine; levofloxacin; lomefloxacin; moxifloxacin; norfloxacin; ofloxacin; pefloxacin; prulifloxacin; rufloxacin.
2 Ciprofloksacin; flumekvin; levofloksacin; lomefloksacin; moksifloksacin; norfloksacin; ofloksacin; pefloksacin; prulifloksacin; rufloksacin.
XEstimated frequency based on placebo-controlled clinical trials and
XOcenjena pogostnost na podlagi kliničnih preskušanj, nadzorovanih s placebom in
In clinical trials, a single dose of infliximab 5 mg/kg was added unless contraindicated.
V kliničnih preskušanjih so dodatno uporabili en sam enkratni odmerek infliksimaba (5 mg/kg), če njegova uporaba ni bila kontraindicirana.
- if you have experienced a previous episode of aortic dissection (a tear in the aorta wall).
- če ste že kdaj doživeli epizodo aortne disekcije (raztrganina aortne stene);
Coughing, wheezing and shortness of breath which may be accompanied by a high temperature
Kašelj, piskanje v pljučih in zadihanost, ki jih lahko spremlja visoka telesna temperatura
Rare side effects (may affect up to 1 in 1000 people)
Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1 000 bolnikov):
- if you have been diagnosed with an enlargement or "bulge" of a large blood vessel (aortic aneurysm or large vessel peripheral aneurysm).
- če so vam postavili diagnozo povečanja ali „izbokline“ velike krvne žile (aortna anevrizma ali periferna anevrizma velike žile);
Infliximab must not be used if gastrointestinal perforation or sepsis is suspected (see the Summary of Product Characteristics for infliximab).
Infliksimaba se ne sme uporabiti v primeru suma na perforacijo v prebavilih ali sepso (glejte povzetek glavnih značilnosti zdravila za infliksimab).
YEstimated frequency of post-marketing surveillance reported adverse reactions; not observed in placebo-controlled clinical trials.
YOcenjena pogostnost neželenih učinkov, o katerih so poročali v obdobju trženja; niso bili opaženi v kliničnih preskušanjih, nadzorovanih s placebom.
What you need to know before you are administered LEMTRADA Warnings and precautions
Kaj morate vedeti, preden boste vzeli zdravilo [ime zdravila] Opozorila in previdnostni ukrepi
Uncommon (may affect up to 1 in 100 people) Infections: […], cytomegalovirus infection
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov): Okužbe: […], okužba s citomegalovirusom2.
Fluoroquinolones for systemic and inhaled use2 - Aortic aneurysm and dissection (EPITT no 18651)
Fluorokinoloni za sistemsko in inhalacijsko uporabo2aortna anevrizma in disekcija (EPITT št. 18651)
Talk to your doctor before taking [product]:
Pred začetkom jemanja zdravila [ime zdravila] se posvetujte z zdravnikom:
Hydrochlorothiazide - Skin cancer (EPITT no 19138)
Hidroklorotiazid - kožni rak (EPITT št. 19138)
Summary of Product Characteristics 4.8.
Povzetek glavnih značilnosti zdravila 4.8.
- if you have a family history of aortic aneurysm or aortic dissection or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, or vascular EhlersDanlos syndrome, or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet's disease, high blood pressure, or known atherosclerosis).
- če imate družinsko zdravstveno zgodovino aortne anevrizme ali aortne disekcije ali druge dejavnike tveganja ali stanja, ki povečajo nagnjenost k nastanku teh bolezni (npr. vezivnotkivne bolezni, kot je Marfanov sindrom, ali žilne oblike Ehlers-Danlosovega sindroma ali žilne bolezni, kot so Takayasujev arteritis, velikocelični arteritis, Behçetova bolezen, visok krvni tlak ali znana ateroskleroza).
Diarrhoea or colitis occurring after initiation of ipilimumab must be promptly evaluated to exclude infectious or other alternate etiologies.
Drisko ali kolitis, ki se pojavita po uvedbi zdravljenja z ipilimumabom, je treba nemudoma ovrednotiti, da se izključi okužb ali drug vzrok.
Duloxetine - Interstitial lung disease (EPITT no 19175)
Duloksetin - intersticijska bolezen pljuč (EPITT št. 19175)
Patients must be monitored for gastrointestinal signs and symptoms that may be indicative of immunerelated colitis or gastrointestinal perforation.
Bolnike je treba nadzirati glede pojava znakov in simptomov v prebavilih, ki bi lahko kazali na pojav imunsko pogojenega kolitisa ali perforacije v prebavilih.
Clinical presentation may include diarrhoea, increased frequency of bowel movements, abdominal pain, or haematochezia, with or without fever.
Klinična slika lahko vključuje drisko, pogostejše odvajanje blata, bolečine v trebuhu ali hematohezijo s povišano telesno temperaturo ali brez.
Talk to your doctor <or> <pharmacist> <or> <nurse> before <taking> <using> X
Pred začetkom <jemanja> <uporabe> zdravila X se posvetujte <z> zdravnikom <ali> <farmacevtom> <ali> <medicinsko sestro>:
Non-melanoma skin cancer: Based on available data from epidemiological studies, cumulative dosedependent association between HCTZ and NMSC has been observed (see also sections 4.4 and 5.1).
Nemelanomski kožni rak: Na podlagi obstoječih podatkov epidemioloških študij so ugotovili, da obstaja razmerje med kumulativnim odmerkom hidroklorotiazida in nemelanomskim kožnim rakom (glejte tudi poglavji 4.4 in 5.1).
However, aAddition of an alternative immunosuppressive agent to the corticosteroid regimen may should be considered in corticosteroid-refractory immune-related colitis if other causes are excluded (including Cytomegalovirus (CMV) infection/reactivation evaluated with viral PCR on biopsy, and other viral, bacterial and parasitic etiology) be considered.
Pri imunsko pogojenem kolitisu, odpornem na zdravljenje s kortikosteroidi, je treba razmisliti Razmisliti je treba o dodatnem zdravljenju z drugim imunosupresivom, poleg zdravljenja s kortikosteroidi, če so izključeni drugi vzroki (vključno z okužbo/reaktivacijo okužbe s citomegalovirusom, ocenjenega z virusnim testom PCR po biopsiji, in drugo virusno, bakterijsko in parazitno etiologijo).
In clinical trials, immune-related colitis was associated with evidence of mucosal inflammation, with or without ulcerations, and lymphocytic and neutrophilic infiltration.
V kliničnih preskušanjih je bil imunsko pogojeni kolitis povezan z znaki vnetja sluznice z razjedami ali brez ter z infiltracijo z limfociti in nevtrofilci.
Undesirable effects Tabulated list of adverse reactions Respiratory, thoracic and mediastinal disorders
Preglednica z neželenimi učinki Bolezni dihal, prsnega koša in mediastinalnega prostora
Undesirable effects Tabulated list of adverse reactions Blood and lymphatic system disorders Frequency ‘uncommon': Thrombocytopenia
Preglednica z neželenimi učinki Bolezni krvi in limfatičnega sistema Pogostnost „občasni“: trombocitopenija
Infections and infestations: cytomegalovirus infection - frequency uncommon
Infekcijske in parazitske bolezni: okužba s citomegalovirusom - pogostnost „občasni“
Frequency ‘rare': Interstitial lung diseaseX
Pogostnost „redki“: intersticijska bolezen pljučX
Special warnings and precautions Immune-related gastrointestinal reactions:
Posebna opozorila in previdnostni ukrepi Imunsko pogojeni neželeni učinki v prebavilih:
Dimethyl fumarate (Tecfidera) - Immune thrombocytopenic purpura and thrombocytopenia (EPITT no
Dimetilfumarat (Tecfidera) - imunska trombocitopenična purpura in trombocitopenija (EPITT št. 19192)
Protect your skin from sun exposure and UV rays while <taking> <using> X 4.
Med <jemanjem> <uporabo> zdravila X zaščitite kožo pred izpostavljenostjo soncu in UV-žarkom.
Special warnings and precautions for use Infections
Posebna opozorila in previdnostni ukrepi Okužbe
Frequency ‘rare': Eosinophilic pneumoniaY
Pogostnost „redki“: eozinofilna pljučnicaY
The experience from clinical trials on the management of corticosteroid-refractory diarrhoea or colitis is limited.
Izkušenj iz kliničnih preskušanj z zdravljenjem driske ali kolitisa, ki sta odporna na zdravljenje s kortikosteroidi, je malo.
Frequency ‘not known': Skin and lip cancer (Non-melanoma skin cancer)
Možni neželeni učinki Pogostnost „neznana“: Kožni rak in rak ustnice (nemelanomski kožni rak)
Ipilimumab - Cytomegalovirus gastrointestinal infection (EPITT no 19207)
Ipilimumab - okužba prebavil s citomegalovirusom (EPITT št. 19207)
Therefore, fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients with positive family history of aneurysm disease, or in patients diagnosed with pre-existing aortic aneurysm and/or aortic dissection, or in presence of other risk factors or conditions predisposing for aortic aneurysm and dissection (e.g. Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet's disease, hypertension, known atherosclerosis).
Pri bolnikih s pozitivno družinsko anamnezo anevrizme ali pri bolnikih, ki so jim postavili diagnozo obstoječe aortne anevrizme in/ali aortne disekcije, ali v prisotnosti drugih dejavnikov tveganja ali stanj, ki so predispozicija za aortno anevrizmo in disekcijo (npr. Marfanov sindrom, vaskularna oblika Ehlers-Danlosovega sindroma, Takayasujev arteritis, velikocelični arteritis, Behçetova bolezen, hipertenzija, znana ateroskleroza), se smejo zato fluorokinoloni uporabljati le po natančni oceni razmerja med koristmi in tveganji ter razmisleku o drugih možnostih zdravljenja.
Post-marketing cases of cytomegalovirus (CMV) infection/reactivation have been reported in patients with corticosteroid-refractory immune-related colitis.
Med obdobjem trženja zdravila so se pri bolnikih z imunsko pogojenim kolitisom, odpornim na zdravljenje s kortikosteroidi, pojavili primeri okužbe/reaktivacije okužbe s citomegalovirusom.
Cytomegalovirus (CMV) infections including cases of CMV reactivation have been reported in LEMTRADA-treated patients.
Pri bolnikih, zdravljenih z zdravilom LEMTRADA, so poročali o okužbah s citomegalovirusom (CMV), vključno z reaktivacijo virusa CMV.
Frequency ‘not known': Non-melanoma skin cancer (Basal cell carcinoma and Squamous cell carcinoma)
Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi) Pogostnost „neznana“: Nemelanomski kožni rak (bazalnocelični karcinom in ploščatocelični karcinom)
Possible side effects Uncommon side effects These may affect up to 1 in 100 people: - reduction in blood platelets
Pojavijo se lahko pri največ 1 od 100 bolnikov: - zmanjšanje števila trombocitov
Stool infections work-up should be performed upon presentation of diarrhoea or colitis to exclude infectious or other alternate etiologies.
Ob pojavu driske ali kolitisa je treba izvesti analizo blata glede okužb, da se izključijo okužba ali drugi vzroki.
Alemtuzumab - Cytomegalovirus infection (EPITT no
Alemtuzumab - okužba s citomegalovirusom (EPITT št. 19193)
Tell your doctor right away if you have symptoms of infection such as fever or swollen glands.
Če imate simptome okužbe, na primer povišano telesno temperaturo ali otekle bezgavke, o tem nemudoma obvestite zdravnika.
ANNEX II[Not applicable for MRP/DCP]
DODATEK PRILOGA II[Not applicable for MRP/DCP]
6.2 Major Iincompatibilities
6.2 Glavne iInkompatibilnosti
<6 months.><…><1 year.><18 months.><2 years.><30 months.><3 years.><use immediately.>
<6 mesecev> <...> <1 leto> <18 mesecev> <2 leti> <30 mesecev> <3 leta.> <uporabite takoj.>
Therefore, it is advisable not to treat animals on the same pasture every season.>
Zato zdravljenje živali na istem pašniku vsako sezono ni priporočljivo.>
<{Invented name} should not enter water courses as this may be dangerous for fish and other aquatic organisms.>
<{Izmišljeno ime} ne sme priti v vodotoke, ker je lahko nevaren za ribe in druge vodne organizme.>
<Official control authority batch release is required for this product.> [only for those immunological veterinary medicinal products which are listed for Official Control Authority Batch Release (OCABR) in accordance with Article 82 of Directive 2001/82/EC as amended.]
<Za to zdravilo je potreben postopek uradne kontrole in sproščanja (OCABR postopek).> [only for those immunological veterinary medicinal products which are listed for Official Control Authority Batch Release (OCABR) in accordance with Article 82 of Directive 2001/82/EC as amended.]
MARKETING AUTHORISATION NUMBER(S) EU/2/00/000/000
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/0/00/000/000
ATC vet code: {lowest available level (e.g. subgroup for chemical substance)}.
, oOznaka ATC vet: {najnižja razpoložljiva raven (npr. podskupina za kemijsko snov)}.
<Alternatively you can report via your national reporting system {national system details}.> [For MRP/DCP only]
<Poročate lahko tudi preko nacionalnega sistema za poročanje {podatki nacionalnega sistema}.> [For MRP/DCP only]
<None known.> <No data available.>
<Niso znane.> <Ni podatkov.>
b) the disease to which the product is intended to confer immunity is largely absent from the territory in question.>
b) bolezen, za katero se z zdravilom pridobi imunost, na zadevnem območju skoraj ni prisotna.
<None known.>
<Niso znane.>
<Do not use within {X} weeks of onset the start of the laying period.>
<Ne uporabite v obdobju {X} tednov pred začetkom obdobja nesnosti .>
<Fertility:> <Do not use in breeding animals.>
<Plodnost:> <Ne uporabite pri vzrejnih živalih.>
<According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
<Skladno z 71. členom Direktive 2001/82/ES Evropskega parlamenta in Sveta z vsemi dopolnitvami in spremembami lahko država članica, skladno z nacionalno zakonodajo, prepove izdelavoproizvajanje, uvoz/vnos, posedovanje, prodajo, oskrbo in/ali uporabo imunološkega zdravila za uporabo v veterinarski medicini na svojem celotnem ozemlju ali delu ozemlja, če ugotovi da:
<Immunocompromised persons are advised to avoid contact with the <vaccine><immunological veterinary medicinal product> and vaccinated animals during {period}.>
<Imunokompromitiranim osebam se svetuje, da se izogibajo stiku s <cepivom> <imunološkim zdravilom> in cepljenimi živalmi {obdobje}.>
<PHARMACOLOGICAL><IMMUNOLOGICAL> PROPERTIES Pharmacotherapeutic group: {group}.
<FARMAKOLOŠKE> <IMUNOLOŠKE> LASTNOSTI Farmakoterapevtska skupina: {skupina}.
These measures should help to protect the environment.>
Taki ukrepi pomagajo varovati okoljeZdravilo odstranite na okolju prijazen način.>
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi), (če je potrebno) 4.11 Karenca <Ni smiselno.>
4.2 Indications for use, specifying the target species <Onset of immunity: {x weeks}> <Duration of immunity: {x years}>
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah <Nastop imunosti: {x tednov}> <Trajanje imunosti: {x let}>
<Laying birds:> <Do not use in <birds in lay><breeding birds> <and within 4 weeks before the onset start of the laying period>.>
< Ptice v obdobju nesnosti:> <Ne uporabite <pri pticah v obdobju nesnosti> < vzrejnihe pticahe> <in/ 4 tedne pred začetkom obdobja nesnosti.>