FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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).
English: leukopenia)
Slovenian: (trombocitopenija)
English: 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.
Slovenian: 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).
English: Median Duration of Response [months (95% CI)]
Slovenian: stopnja dosežene klinične koristi (ORR+MR) [n (%)] mediano trajanje odziva [meseci (95-odstotni IZ)]
English: Leukopenia
Slovenian: Hrvatska
English: Urinary tract infection Common Influenza
Slovenian: Žilne bolezni hipertenzija zelo pogosti
English: Figure 4: Kaplan-Meier Curve of PFS in Study MMY3004
Slovenian: Slika 4: Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni v študiji MMY3004
English: DARZALEX is given as an infusion (drip) into a vein.
Slovenian: Zdravilo DARZALEX boste prejeli v veno z infuzijo.
English: 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.
Slovenian: 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
English: Adopted at the 3-6 September 2018 PRAC
Slovenian: Sprejeto na seji odbora PRAC med 3. in 6. septembrom 2018
English: Most cases occurred within 2 months of alemtuzumab dosing.
Slovenian: Večina primerov se je pojavila v dveh mesecih po odmerku alemtuzumaba.
English: - if you have had skin cancer or if you develop an unexpected skin lesion during the treatment.
Slovenian: - če ste imeli kožnega raka ali če se vam med zdravljenjem pojavijo nepričakovane kožne spremembe.
English: 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).
Slovenian: 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).
English: 2 Ciprofloxacin; flumequine; levofloxacin; lomefloxacin; moxifloxacin; norfloxacin; ofloxacin; pefloxacin; prulifloxacin; rufloxacin.
Slovenian: 2 Ciprofloksacin; flumekvin; levofloksacin; lomefloksacin; moksifloksacin; norfloksacin; ofloksacin; pefloksacin; prulifloksacin; rufloksacin.
English: XEstimated frequency based on placebo-controlled clinical trials and
Slovenian: XOcenjena pogostnost na podlagi kliničnih preskušanj, nadzorovanih s placebom in
English: In clinical trials, a single dose of infliximab 5 mg/kg was added unless contraindicated.
Slovenian: V kliničnih preskušanjih so dodatno uporabili en sam enkratni odmerek infliksimaba (5 mg/kg), če njegova uporaba ni bila kontraindicirana.
English: - if you have experienced a previous episode of aortic dissection (a tear in the aorta wall).
Slovenian: - če ste že kdaj doživeli epizodo aortne disekcije (raztrganina aortne stene);
English: Coughing, wheezing and shortness of breath which may be accompanied by a high temperature
Slovenian: Kašelj, piskanje v pljučih in zadihanost, ki jih lahko spremlja visoka telesna temperatura
English: Rare side effects (may affect up to 1 in 1000 people)
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1 000 bolnikov):
English: - if you have been diagnosed with an enlargement or "bulge" of a large blood vessel (aortic aneurysm or large vessel peripheral aneurysm).
Slovenian: - če so vam postavili diagnozo povečanja ali „izbokline“ velike krvne žile (aortna anevrizma ali periferna anevrizma velike žile);
English: Infliximab must not be used if gastrointestinal perforation or sepsis is suspected (see the Summary of Product Characteristics for infliximab).
Slovenian: Infliksimaba se ne sme uporabiti v primeru suma na perforacijo v prebavilih ali sepso (glejte povzetek glavnih značilnosti zdravila za infliksimab).
English: YEstimated frequency of post-marketing surveillance reported adverse reactions; not observed in placebo-controlled clinical trials.
Slovenian: YOcenjena pogostnost neželenih učinkov, o katerih so poročali v obdobju trženja; niso bili opaženi v kliničnih preskušanjih, nadzorovanih s placebom.
English: What you need to know before you are administered LEMTRADA Warnings and precautions
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo [ime zdravila] Opozorila in previdnostni ukrepi
English: Uncommon (may affect up to 1 in 100 people) Infections: […], cytomegalovirus infection
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov): Okužbe: […], okužba s citomegalovirusom2.
English: Fluoroquinolones for systemic and inhaled use2 - Aortic aneurysm and dissection (EPITT no 18651)
Slovenian: Fluorokinoloni za sistemsko in inhalacijsko uporabo2aortna anevrizma in disekcija (EPITT št. 18651)
English: Talk to your doctor before taking [product]:
Slovenian: Pred začetkom jemanja zdravila [ime zdravila] se posvetujte z zdravnikom:
English: Hydrochlorothiazide - Skin cancer (EPITT no 19138)
Slovenian: Hidroklorotiazid - kožni rak (EPITT št. 19138)
English: Summary of Product Characteristics 4.8.
Slovenian: Povzetek glavnih značilnosti zdravila 4.8.
English: - 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).
Slovenian: - 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).
English: Diarrhoea or colitis occurring after initiation of ipilimumab must be promptly evaluated to exclude infectious or other alternate etiologies.
Slovenian: Drisko ali kolitis, ki se pojavita po uvedbi zdravljenja z ipilimumabom, je treba nemudoma ovrednotiti, da se izključi okužb ali drug vzrok.
English: Duloxetine - Interstitial lung disease (EPITT no 19175)
Slovenian: Duloksetin - intersticijska bolezen pljuč (EPITT št. 19175)
English: Patients must be monitored for gastrointestinal signs and symptoms that may be indicative of immunerelated colitis or gastrointestinal perforation.
Slovenian: Bolnike je treba nadzirati glede pojava znakov in simptomov v prebavilih, ki bi lahko kazali na pojav imunsko pogojenega kolitisa ali perforacije v prebavilih.
English: Clinical presentation may include diarrhoea, increased frequency of bowel movements, abdominal pain, or haematochezia, with or without fever.
Slovenian: Klinična slika lahko vključuje drisko, pogostejše odvajanje blata, bolečine v trebuhu ali hematohezijo s povišano telesno temperaturo ali brez.
English: Talk to your doctor <or> <pharmacist> <or> <nurse> before <taking> <using> X
Slovenian: Pred začetkom <jemanja> <uporabe> zdravila X se posvetujte <z> zdravnikom <ali> <farmacevtom> <ali> <medicinsko sestro>:
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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).
English: In clinical trials, immune-related colitis was associated with evidence of mucosal inflammation, with or without ulcerations, and lymphocytic and neutrophilic infiltration.
Slovenian: V kliničnih preskušanjih je bil imunsko pogojeni kolitis povezan z znaki vnetja sluznice z razjedami ali brez ter z infiltracijo z limfociti in nevtrofilci.
English: Undesirable effects Tabulated list of adverse reactions Respiratory, thoracic and mediastinal disorders
Slovenian: Preglednica z neželenimi učinki Bolezni dihal, prsnega koša in mediastinalnega prostora
English: Undesirable effects Tabulated list of adverse reactions Blood and lymphatic system disorders Frequency ‘uncommon': Thrombocytopenia
Slovenian: Preglednica z neželenimi učinki Bolezni krvi in limfatičnega sistema Pogostnost „občasni“: trombocitopenija
English: Infections and infestations: cytomegalovirus infection - frequency uncommon
Slovenian: Infekcijske in parazitske bolezni: okužba s citomegalovirusom - pogostnost „občasni“
English: Frequency ‘rare': Interstitial lung diseaseX
Slovenian: Pogostnost „redki“: intersticijska bolezen pljučX
English: Special warnings and precautions Immune-related gastrointestinal reactions:
Slovenian: Posebna opozorila in previdnostni ukrepi Imunsko pogojeni neželeni učinki v prebavilih:
English: Dimethyl fumarate (Tecfidera) - Immune thrombocytopenic purpura and thrombocytopenia (EPITT no
Slovenian: Dimetilfumarat (Tecfidera) - imunska trombocitopenična purpura in trombocitopenija (EPITT št. 19192)
English: Protect your skin from sun exposure and UV rays while <taking> <using> X 4.
Slovenian: Med <jemanjem> <uporabo> zdravila X zaščitite kožo pred izpostavljenostjo soncu in UV-žarkom.
English: Special warnings and precautions for use Infections
Slovenian: Posebna opozorila in previdnostni ukrepi Okužbe
English: Frequency ‘rare': Eosinophilic pneumoniaY
Slovenian: Pogostnost „redki“: eozinofilna pljučnicaY
English: The experience from clinical trials on the management of corticosteroid-refractory diarrhoea or colitis is limited.
Slovenian: Izkušenj iz kliničnih preskušanj z zdravljenjem driske ali kolitisa, ki sta odporna na zdravljenje s kortikosteroidi, je malo.
English: Frequency ‘not known': Skin and lip cancer (Non-melanoma skin cancer)
Slovenian: Možni neželeni učinki Pogostnost „neznana“: Kožni rak in rak ustnice (nemelanomski kožni rak)
English: Ipilimumab - Cytomegalovirus gastrointestinal infection (EPITT no 19207)
Slovenian: Ipilimumab - okužba prebavil s citomegalovirusom (EPITT št. 19207)
English: 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).
Slovenian: 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.
English: Post-marketing cases of cytomegalovirus (CMV) infection/reactivation have been reported in patients with corticosteroid-refractory immune-related colitis.
Slovenian: Med obdobjem trženja zdravila so se pri bolnikih z imunsko pogojenim kolitisom, odpornim na zdravljenje s kortikosteroidi, pojavili primeri okužbe/reaktivacije okužbe s citomegalovirusom.
English: Cytomegalovirus (CMV) infections including cases of CMV reactivation have been reported in LEMTRADA-treated patients.
Slovenian: Pri bolnikih, zdravljenih z zdravilom LEMTRADA, so poročali o okužbah s citomegalovirusom (CMV), vključno z reaktivacijo virusa CMV.
English: Frequency ‘not known': Non-melanoma skin cancer (Basal cell carcinoma and Squamous cell carcinoma)
Slovenian: Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi) Pogostnost „neznana“: Nemelanomski kožni rak (bazalnocelični karcinom in ploščatocelični karcinom)
English: Possible side effects Uncommon side effects These may affect up to 1 in 100 people: - reduction in blood platelets
Slovenian: Pojavijo se lahko pri največ 1 od 100 bolnikov: - zmanjšanje števila trombocitov
English: Stool infections work-up should be performed upon presentation of diarrhoea or colitis to exclude infectious or other alternate etiologies.
Slovenian: Ob pojavu driske ali kolitisa je treba izvesti analizo blata glede okužb, da se izključijo okužba ali drugi vzroki.
English: Alemtuzumab - Cytomegalovirus infection (EPITT no
Slovenian: Alemtuzumab - okužba s citomegalovirusom (EPITT št. 19193)
English: Tell your doctor right away if you have symptoms of infection such as fever or swollen glands.
Slovenian: Če imate simptome okužbe, na primer povišano telesno temperaturo ali otekle bezgavke, o tem nemudoma obvestite zdravnika.
English: ANNEX II[Not applicable for MRP/DCP]
Slovenian: DODATEK PRILOGA II[Not applicable for MRP/DCP]
English: 6.2 Major Iincompatibilities
Slovenian: 6.2 Glavne iInkompatibilnosti
English: <6 months.><…><1 year.><18 months.><2 years.><30 months.><3 years.><use immediately.>
Slovenian: <6 mesecev> <...> <1 leto> <18 mesecev> <2 leti> <30 mesecev> <3 leta.> <uporabite takoj.>
English: Therefore, it is advisable not to treat animals on the same pasture every season.>
Slovenian: Zato zdravljenje živali na istem pašniku vsako sezono ni priporočljivo.>
English: <{Invented name} should not enter water courses as this may be dangerous for fish and other aquatic organisms.>
Slovenian: <{Izmišljeno ime} ne sme priti v vodotoke, ker je lahko nevaren za ribe in druge vodne organizme.>
English: <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.]
Slovenian: <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.]
English: MARKETING AUTHORISATION NUMBER(S) EU/2/00/000/000
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/0/00/000/000
English: ATC vet code: {lowest available level (e.g. subgroup for chemical substance)}.
Slovenian: , oOznaka ATC vet: {najnižja razpoložljiva raven (npr. podskupina za kemijsko snov)}.
English: <Alternatively you can report via your national reporting system {national system details}.> [For MRP/DCP only]
Slovenian: <Poročate lahko tudi preko nacionalnega sistema za poročanje {podatki nacionalnega sistema}.> [For MRP/DCP only]
English: <None known.> <No data available.>
Slovenian: <Niso znane.> <Ni podatkov.>
English: b) the disease to which the product is intended to confer immunity is largely absent from the territory in question.>
Slovenian: b) bolezen, za katero se z zdravilom pridobi imunost, na zadevnem območju skoraj ni prisotna.
English: <None known.>
Slovenian: <Niso znane.>
English: <Do not use within {X} weeks of onset the start of the laying period.>
Slovenian: <Ne uporabite v obdobju {X} tednov pred začetkom obdobja nesnosti .>
English: <Fertility:> <Do not use in breeding animals.>
Slovenian: <Plodnost:> <Ne uporabite pri vzrejnih živalih.>
English: <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:
Slovenian: <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:
English: <Immunocompromised persons are advised to avoid contact with the <vaccine><immunological veterinary medicinal product> and vaccinated animals during {period}.>
Slovenian: <Imunokompromitiranim osebam se svetuje, da se izogibajo stiku s <cepivom> <imunološkim zdravilom> in cepljenimi živalmi {obdobje}.>
English: <PHARMACOLOGICAL><IMMUNOLOGICAL> PROPERTIES Pharmacotherapeutic group: {group}.
Slovenian: <FARMAKOLOŠKE> <IMUNOLOŠKE> LASTNOSTI Farmakoterapevtska skupina: {skupina}.
English: These measures should help to protect the environment.>
Slovenian: Taki ukrepi pomagajo varovati okoljeZdravilo odstranite na okolju prijazen način.>
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi), (če je potrebno) 4.11 Karenca <Ni smiselno.>
English: 4.2 Indications for use, specifying the target species <Onset of immunity: {x weeks}> <Duration of immunity: {x years}>
Slovenian: 4.2 Indikacije za uporabo pri ciljnih živalskih vrstah <Nastop imunosti: {x tednov}> <Trajanje imunosti: {x let}>
English: <Laying birds:> <Do not use in <birds in lay><breeding birds> <and within 4 weeks before the onset start of the laying period>.>
Slovenian: < Ptice v obdobju nesnosti:> <Ne uporabite <pri pticah v obdobju nesnosti> < vzrejnihe pticahe> <in/ 4 tedne pred začetkom obdobja nesnosti.>
English: Since this <vaccine> <immunological veterinary medicinal product> has been prepared with live, attenuated microorganisms, appropriate measures should be taken to prevent contamination of the handler and other people that collaborate in the process.>
Slovenian: Ker je bilo <cepivo> <imunološko zdravilo> izdelano iz živih oslabljenih mikroorganizmov, so potrebni ustrezni ukrepi, da bi preprečili okužbo osebe, ki pride v stik s cepivom ter drugih oseb, ki sodelujejo pri cepljenju.>
English: <The <vaccine><immunological veterinary medicinal product> can be pathogenic for humans.
Slovenian: <Cepivo> <imunološko zdravilo> je za človeka lahko patogeno.
English: <5.1 Pharmacodynamic properties> <5.2 Pharmacokinetic particulars> <Environmental properties>
Slovenian: <5.1 Farmakodinamične lastnosti> <5.2 Farmakokinetični podatki>
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Slovenian: <Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/.
English: <Not applicable.> <In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.> <Do not mix with any other veterinary medicinal product<, except <diluentsolvent or other component> <recommended><supplied> <for use with the veterinary medicinal product>.>
Slovenian: <Ni smiselno.> <Zaradi pomanjkanja študij kompatibilnosti tega zdravila ne smemo mešati z drugimi zdravili za uporabo v veterinarski medicini.> <Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini <, razen z vehikloms topilom ali drugo komponento> <, ki je priporočena> <, ki je priložena> < za uporabo s tem <zdravilom><cepivom>>.>
English: Personnel involved in attending vaccinated {species} should follow general hygiene principles (changing clothes, wearing gloves, cleaning and disinfection of boots) and take particular care in handling animal waste and bedding materials litter from recently vaccinated {species}.>
Slovenian: Osebje, ki oskrbujejo cepljene {živalske vrste} morajo upoštevati splošna higienska načela (menjava obleke, uporaba rokavic, čiščenje in razkuževanje čevljev) in morajo še posebej paziti pri ravnanju s steljoz iztrebkiizločki in steljonastiljem {živalskih vrst}, ki so bile pred kratkim cepljene.> <Namenjeno uporabniku:
English: <This veterinary medicinal product does not require any special temperature storage conditions.>*****
Slovenian: <Za shranjevanje zdravila ni posebnih temperaturnih omejitev.>*****
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Slovenian: Če opazite kakršne koli resne stranske učinke, tudi tiste, ki niso navedeni v tem navodilu za uporabo ali mislite, da zdravilo ni delovalo, druge učinke, ki niso omenjeni v teh navodilih za uporabo,
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: <POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO