FrancophonIA/ELRC3.0 huggingface dataset:
English: A grade 4 decrease in serum calcium levels was experienced in 0.6% of patients treated with XGEVA and 0.2% of patients treated with zoledronic acid (see section 4.4).
Slovenian: Znižanje koncentracije kalcija v serumu 4. stopnje se je pojavilo pri 0,6 % bolnikov, zdravljenih z zdravilom XGEVA, in pri 0,2 % bolnikov, zdravljenih z zoledronsko kislino (glejte poglavje 4.4).
English: In the post-marketing setting, musculoskeletal pain, including severe cases, has been reported in patients receiving XGEVA.
Slovenian: Med obdobjem trženja zdravila so pri bolnikih, ki so dobivali zdravilo XGEVA, poročali o mišično-skeletni bolečini, vključno s hudimi primeri.
English: Patients treated with XGEVA should be given the package leaflet and the patient reminder card. Prevention of skeletal related events in adults with advanced malignancies involving bone The recommended dose is 120 mg administered as a single subcutaneous injection once every 4 weeks into the thigh, abdomen or upper arm.
Slovenian: Preprečevanje skeletnih dogodkov pri odraslih z napredovanimi malignomi, ki zajamejo kosti Priporočeni odmerek je 120 mg enkrat na 4 tedne v enkratni subkutani injekciji v stegno, trebuh ali nadlaket.
English: There were no clinically-relevant alterations in trough serum concentration and pharmacodynamics of denosumab (creatinine adjusted urinary N-telopeptide, uNTx/Cr) by concomitant chemotherapy and/or hormone therapy or by previous intravenous bisphosphonate exposure.
Slovenian: Sočasna kemoterapija in/ali hormonsko zdravljenje ali predhodna intravenska izpostavljenost bisfosfonatom niso klinično pomembno spremenili najmanjše koncentracije denosumaba v serumu in farmakodinamike denosumaba (N-telopeptid v urinu, prilagojen na kreatinin, uNTx/Cr).
English: NR = not reached; NA = not available; HCM = hypercalcaemia of malignancy; SMR = skeletal morbidity rate; HR = Hazard Ratio; RRR = Relative Risk Reduction †Adjusted p-values are presented for Studies 1, 2 and 3 (first SRE and first and subsequent SRE endpoints); *Accounts for all skeletal events over time; only events occurring ≥ 21 days after the previous event are counted.
Slovenian: ND = ni doseženo, NP = ni podatka, HKM = hiperkalciemija zaradi malignoma, DSO = stopnja skeletne obolevnosti, HR = razmerje ogroženosti (HR - Hazard Ratio), RRR = zmanjšanje relativnega tveganja (RRR - Relative Risk Reduction).
English: The safety and efficacy of XGEVA was studied in two phase II open-label, single-arm trials (studies 5 and 6) that enrolled 529 patients with giant cell tumour of bone that was either unresectable or for which surgery would be associated with severe morbidity.
Slovenian: faze z eno samo skupino (študiji 5 in 6), ki sta zajeli 529 bolnikov z gigantocelularnim kostnim tumorjem, ki je bil inoperabilen, ali je bil takšen, da bi kirurški poseg spremljala huda obolevnost.
English: The following risk factors should be considered when evaluating a patient's risk of developing ONJ:
Slovenian: Pri ocenjevanju bolnikovega tveganja za pojav osteonekroze čeljustnice je treba upoštevati naslednje dejavnike tveganja:
English: Combined advanced cancer
Slovenian: Kombinirano napredovani rak zdravilo XGEVA
English: Treatment of skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity: the posology is the same as in adults.
Slovenian: Odmerjanje za zdravljenje skeletno dozorelih mladostnikov z gigantocelularnim kostnim tumorjem, ki ni operabilen, ali pri katerem bi kirurška odstranitev verjetno povzročila hudo obolevnost, je enako kot za odrasle.
English: XGEVA reduced the risk of developing a SRE, and developing multiple SREs (first and subsequent) in patients with bone metastases from solid tumours (see table 2).
Slovenian: Zdravilo XGEVA je bolnikom s kostnimi metastazami solidnih tumorjev zmanjšalo tveganje za pojav SRE in pojav (prvih ali nadaljnjih) multiplih SRE (glejte preglednico 2).
English: Denosumab 120 mg Q4W Zoledronic Acid 4 mg Q4W
Slovenian: Denosumab 120 mg na 4 tedne Zoledronska kislina 4 mg na 4 tedne
English: A side effect called osteonecrosis of the jaw (bone damage in the jaw) has been reported commonly (may affect up to 1 in 10 people) in patients receiving XGEVA injections for cancer-related conditions.
Slovenian: Pri bolnikih, ki so dobivali injekcije zdravila XGEVA zaradi bolezni, povezanih z rakom, so pogosto (pojavi se pri do 1 od 10 oseb) poročali o neželenem učinku, ki ga imenujemo osteonekroza čeljustnice (odmiranje kosti v čeljusti).
English: - if you are allergic to denosumab or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo XGEVA Ne uporabljajte zdravila XGEVA: - če ste alergični na denosumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: NR NR NR NR NR 28.6
Slovenian: ND ND ND ND ND 28,6
English: First radiation to bone Hazard ratio (95% CI)
Slovenian: Prvo obsevanje kosti Razmerje ogroženosti (95 % IZ)
English: There is no need for renal monitoring with XGEVA dosing.
Slovenian: Med odmerjanjem zdravila XGEVA kontroliranje ledvic ni potrebno.
English: Non-inferiority / Superiority p-values
Slovenian: Vrednosti p za neinferiornost / superiornost Delež bolnikov (%)
English: In the post-marketing setting, events of hypersensitivity, including rare events of anaphylactic reactions, have been reported in patients receiving XGEVA.
Slovenian: Z zdravilom povezane preobčutljivostne reakcije V obdobju trženja zdravila so pri bolnikih, ki prejemajo zdravilo XGEVA, poročali o primerih preobčutljivosti, vključno z redkimi primeri anafilaktičnih reakcij.
English: A grade 3 decrease in serum calcium levels was experienced in 2.5% of patients treated with XGEVA and 1.2% of patients treated with zoledronic acid.
Slovenian: Znižanje koncentracije kalcija v serumu 3. stopnje se je pojavilo pri 2,5 % bolnikov, zdravljenih z zdravilom XGEVA, in pri 1,2 % bolnikov, zdravljenih z zoledronsko kislino.
English: In phase II clinical studies of patients with advanced malignancies involving bone, subcutaneous (SC) dosing of XGEVA administered either every 4 weeks (Q4W) or every 12 weeks resulted in a rapid reduction in markers of bone resorption (uNTx/Cr, serum CTx), with median reductions of approximately 80% for uNTx/Cr occurring within 1 week regardless of prior bisphosphonate therapy or baseline uNTx/Cr level.
Slovenian: faze pri bolnikih z napredovalimi malignomi, ki so zajeli kosti, je subkutana (s.c.) uporaba zdravila XGEVA, aplicirana bodisi na 4 tedne bodisi na 12 tednov, povzročila hitro znižanje označevalcev resorpcije kosti (uNTx/kreatinin, serumski CTx).
English: Cases of osteonecrosis of the jaw (see sections 4.4 and section 4.8 - description of selected adverse reactions) have been commonly observed in patients taking XGEVA.
Slovenian: Pri bolnikih, ki prejemajo zdravilo XGEVA, so pogosto opazili primere osteonekroze čeljustnice (glejte poglavje 4.4 in poglavje 4.8 - Opis izbranih neželenih učinkov).
English: Your doctor will then help you decide whether to stop breast-feeding or whether to stop taking XGEVA, considering the benefit of breast-feeding to the baby and the benefit of XGEVA to the mother.
Slovenian: Na podlagi upoštevanja koristi dojenja za otroka in koristi zdravljenja z zdravilom XGEVA za mater vam bo zdravnik pomagal pri odločitvi, ali prenehati z dojenjem ali prenehati z jemanjem zdravila XGEVA.
English: The decreases in serum calcium were generally appropriately managed by calcium and vitamin D supplementation.
Slovenian: Znižanje kalcija v serumu so na splošno ustrezno odpravili z dodatki kalcija in vitamina D. Najbolj pogosti neželeni učinki zdravila XGEVA so mišično-skeletne bolečine.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 120 mg of denosumab in 1.7 mL of solution (70 mg/mL).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena viala vsebuje 120 mg denosumaba v 1,7 ml raztopine (70 mg/ml).
English: XGEVA contains sodium
Slovenian: Zdravilo XGEVA vsebuje natrij
English: ONJ has been reported commonly in patients receiving XGEVA (see section 4.8).
Slovenian: Pri bolnikih, zdravljenih z zdravilom XGEVA, so o osteonekrozi čeljustnice poročali pogosto (glejte poglavje 4.8).
English: In studies 1, 2 and 3, overall survival was balanced between XGEVA and zoledronic acid in patients with advanced malignancies involving bone: patients with breast cancer (hazard ratio and 95% CI was 0.95 [0.81, 1.11]), patients with prostate cancer (hazard ratio and 95% CI was 1.03 [0.91, 1.17]), and patients with other solid tumours or multiple myeloma (hazard ratio and 95% CI was 0.95 [0.83, 1.08]).
Slovenian: (razmerje ogroženosti in 95 % IZ 0,95 [0,81, 1,11]), bolniki z rakom prostate (razmerje ogroženosti in 95 % IZ 1,03 [0,91, 1,17]) in bolniki z drugimi solidnimi tumorji ali diseminiranim plazmocitomom (razmerje ogroženosti in 95 % IZ 0,95 [0,83, 1,08]).
English: N = Number of subjects randomised * = Statistically significant for superiority; ** = Statistically significant for non-inferiority
Slovenian: ZA = Zoledronska kislina 4 mg na 4 tedne N = Število randomiziranih preiskovancev * = Statistično značilno za superiornostf; ** = Statistično značilno za neinferiornost
English: Contact your doctor if you experience new or unusual pain in your hip, groin, or thigh.
Slovenian: Če se vam pojavi nova ali neobičajna bolečina v kolku, dimljah ali stegnu, se posvetujte z zdravnikom.
English: Hypocalcaemia1, 2
Slovenian: Presnovne in prehranske motnje zelo pogosti hipokalciemija1, 2
English: • persistent pain in the mouth and/or jaw, and/or swelling or non-healing of sores in the mouth or jaw, discharge, numbness or feeling of heaviness in the jaw, or loosening of a tooth could be signs of bone damage in the jaw (osteonecrosis).
Slovenian: • trajna bolečina v ustih in/ali čeljustnici, in/ali oteklost ali neceljenje razjed v ustih ali čeljustnici,
English: Denosumab is a human monoclonal antibody (IgG2) that targets and binds with high affinity and specificity to RANKL, preventing the RANKL/RANK interaction from occurring and resulting in reduced osteoclast numbers and function, thereby decreasing bone resorption and cancer-induced bone destruction.
Slovenian: Tako prepreči pojav interakcije RANKL/RANK ter zmanjša število in delovanje osteoklastov, s čimer zmanjša resorpcijo kosti in z rakom povzročeno razgradnjo kosti.
English: Patients with prior history of ONJ or osteomyelitis of the jaw, an active dental or jaw condition requiring oral surgery, non-healed dental/oral surgery, or any planned invasive dental procedure, were not eligible for inclusion in these studies.
Slovenian: Za vključitev v te študije niso bili primerni bolniki s predhodno anamnezo osteonekroze čeljustnice ali osteomielitisa čeljustnice, aktivno zobno ali čeljustno boleznijo, ki je zahtevala kirurški poseg v ustih, nezaceljenim stanjem po zobnem/ustnem kirurškem posegu ali katerim koli načrtovanim invazivnim zobozdravstvenim posegom.
English: First radiation to bone Median time (months)
Slovenian: Vrednosti p za superiornost Prvo obsevanje kosti Mediana čas (meseci)
English: The start of treatment/new treatment course should be delayed in patients with unhealed open soft tissue lesions in the mouth.
Slovenian: Pri bolnikih, ki imajo nezaceljene lezije mehkih tkiv v ustih, je treba začetek zdravljenja/nov ciklus zdravljenja odložiti.
English: Clinically significant hypercalcaemia requiring hospitalisation and complicated by acute renal injury has been reported in XGEVA-treated patients with giant cell tumour of bone weeks to months following treatment discontinuation.
Slovenian: Pri bolnikih z gigantocelularnim kostnim tumorjem, ki so bili zdravljeni z zdravilom XGEVA, so še tedne do mesece po prenehanju zdravljenja poročali o klinično pomembni hiperkalciemiji, pri kateri je bilo potrebno bolnišnično zdravljenje in se je zapletla z akutno okvaro ledvic.
English: Rare side effects (may affect up to 1 in 1,000 people):
Slovenian: Redki neželeni učinki (lahko se pojavijo pri največ 1 od 1.000 bolnikov)
English: Hypercalcaemia following treatment discontinuation in patients with giant cell tumour of bone3
Slovenian: pogosti hipofosfatemija občasni hiperkalciemija po prenehanju zdravljenja pri bolnikih z gigantocelularnim kostnim tumorjem3
English: A grade 3 decrease in serum calcium levels was experienced in 1.4% of patients treated with XGEVA and 0.6% of patients treated with zoledronic acid.
Slovenian: Znižanje koncentracije kalcija v serumu 3. stopnje se je pojavilo pri 1,4 % bolnikov, zdravljenih z zdravilom XGEVA, in pri 0,6 % bolnikov, zdravljenih z zoledronsko kislino.
English: • To avoid discomfort at the site of injection, allow the vial to reach room temperature (up to
Slovenian: • Za preprečitev nelagodja na mestu dajanja je treba zagotoviti, da viala pred injiciranjem doseže sobno temperaturo (do 25 °C), zdravilo pa je treba injicirati počasi.
English: A grade 4 decrease in serum calcium levels was experienced in 0.4% of patients treated with XGEVA and 0.1% of patients treated with zoledronic acid.
Slovenian: Znižanje koncentracije kalcija v serumu 4. stopnje se je pojavilo pri 0,4 % bolnikov, zdravljenih z zdravilom XGEVA, in pri 0,1 % bolnikov, zdravljenih z zoledronsko kislino.
English: - If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: - Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/703/001 1 single use vial EU/1/11/703/002 4 single use vials EU/1/11/703/003 3 single use vials
Slovenian: EU/1/11/703/002 - 4 viale za enkratno uporabo
English: The patient-year adjusted incidence of ONJ was 0.2% during the first year of treatment and 1.7% in the second year.
Slovenian: Incidenca osteonekroze čeljustnice, korigirana za bolnik-leta, je bila prvo leto zdravljenja 0,2 % in drugo leto
English: Efficacy results in patients with advanced malignancies involving bone Study 1 breast cancer
Slovenian: Rezultati učinkovitosti pri bolnikih z napredovanimi malignomi, ki so zajeli kosti
English: • shortness of breath,
Slovenian: • kratka sapa,
English: A higher incidence of hypocalcaemia among subjects treated with denosumab compared to zoledronic acid has been observed in SRE prevention clinical trials.
Slovenian: V kliničnih preskušanjih preprečevanja skeletnih dogodkov so opažali večjo pojavnost hipokalciemije med bolniki, zdravljenimi z denosumabom, kot med bolniki, zdravljenimi z zoledronsko kislino.
English: XGEVA is not recommended for use if you are pregnant.
Slovenian: Če ste noseči, uporaba zdravila XGEVA ni priporočljiva.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva zelo pogosti mišično-skeletna bolečina1
English: XGEVA is also used to treat giant cell tumour of bone, which cannot be treated by surgery or where surgery is not the best option, in adults and adolescents whose bones have stopped growing.
Slovenian: Pri odraslih in pri mladostnikih, pri katerih se je kostna rast končala, se zdravilo XGEVA uporablja tudi za zdravljenje gigantocelularnega kostnega tumorja, ki ga ni mogoče zdraviti z operacijo, ali če operacija ni najboljša možnost.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1.7 mL
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
English: Accompanying increases in parathyroid hormone have also been observed in patients receiving XGEVA with severe renal impairment or receiving dialysis.
Slovenian: Pri bolnikih, ki so dobivali zdravilo XGEVA in so imeli hudo okvaro ledvic ali so bili na dializi, so opažali tudi spremljajoče zvišanje paratiroidnega hormona.
English: Your doctor will monitor you for signs and symptoms of high levels of calcium, after you stop receiving XGEVA.
Slovenian: Ko boste zdravilo XGEVA prenehali jemati, vas bo vaš zdravnik spremljal glede pojava znakov in simptomov visokih ravni kalcija.
English: Drug hypersensitivity1
Slovenian: Bolezni imunskega sistema redki preobčutljivost na zdravilo1
English: - The active substance is denosumab.
Slovenian: Zdravilo XGEVA vsebuje denosumab.
English: Water for injections * Acetate buffer is formed by mixing acetic acid with sodium hydroxide
Slovenian: 6.1 Seznam pomožnih snovi ledocet* natrijev hidroksid (za prilagoditev pH)* sorbitol (E420) polisorbat 20 voda za injekcije * acetatni pufer nastane z mešanjem ocetne kisline z natrijevim hidroksidom
English: In the post-marketing setting, severe symptomatic hypocalcaemia (including fatal cases) has been reported (see section 4.8), with most cases occurring in the first weeks of initiating therapy, but can occur later.
Slovenian: V obdobju trženja zdravila so poročali o hudi simptomatski hipokalciemiji (vključno s smrtnimi primeri) (glejte poglavje 4.8).
English: 1 See section Description of selected adverse reactions 2 See section Other special populations 3 See section 4.4
Slovenian: 2 Glejte poglavje Druge posebne skupine bolnikov.
English: GENERAL CLASSIFICATION FOR SUPPLY
Slovenian: Opozorila glede pomožnih snovi
English: A higher incidence of ONJ among subjects treated with denosumab compared to zoledronic acid has been observed in SRE prevention clinical trials.
Slovenian: V kliničnih preskušanjih preprečevanja skeletnih dogodkov so opažali večjo pojavnost osteonekroze čeljustnice med bolniki, zdravljenimi z denosumabom, kot med bolniki, zdravljenimi z zoledronsko kislino.
English: Osteonecrosis of the jaw1
Slovenian: pogosti osteonekroza čeljustnice1
English: 42 months
Slovenian: 42 mesecev
English: Date of last renewal: 10/06/2015
Slovenian: Datum zadnjega podaljšanja: 10/06/2015
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 08/07/2005
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve pridobitve dovoljenja: 08/07/2005
English: ATC vet code: QI05AB03
Slovenian: Oznaka ATC-vet: QI05AB03
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) 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).
Slovenian: Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosto (pri več kot 1 živali od 10 živali stranski učinki v času zdravljenja) - pogosto (pri več kot 1 živali toda manj kot pri 10 živalih od 100 živali) - nepogosto (pri več kot 1 živali toda manj kot pri 10 živalih od 1.000 živali) - redko (pri več kot 1 živali toda manj kot pri 10 živalih od 10.000 živali) - zelo redko (pri manj kot 1 živali na 10.000 živali, vključno s posameznimi primeri)
English: PACKAGE SIZE 10 x 1 dose
Slovenian: VELIKOST PAKIRANJA 10 x 1 odmerek
English: 62.5 µg For the full list of excipients, see section 6.1
Slovenian: 62,5 µg Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.
Slovenian: Če opazite kakršne koli resne učinke ali druge učinke, ki niso navedeni v tem navodilu, obvestite svojega veterinarja.
English: A third vaccination with Equilis Te should be repeated at least four weeks later.
Slovenian: Tretje cepljenje z Equilisom Te moramo ponoviti najmanj štiri tedne pozneje.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) 470/2009.
Slovenian: Zdravilna učinkovina je učinkovina biološkega izvora, namenjena za vzbujanje aktivne imunosti, in ni zajeta v Uredbi (ES) 470/2009.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Tetanus toxoid 40 Lf/ml
Slovenian: NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Toksoid tetanusa 40 Lf/ml
English: In very rare cases a local reaction exceeding 5 cm and possibly persisting longer than 2 days may occur.
Slovenian: V zelo redkih primerih lokalna reakcija presega 5 cm in lahko traja dlje kot 2 dni.
English: ADVICE ON CORRECT ADMINISTRATION Allow the vaccine to reach room temperature before use.
Slovenian: NASVET O PRAVILNI UPORABI ZDRAVILA Cepivo pred uporabo ogrejte na sobno temperaturo.
English: Store in a refrigerator (2°C -8°C).
Slovenian: Shranjujte v hladilniku (2°C -8 °C).
English: Store in a refrigerator (2 °C - 8 °C).
Slovenian: Shranjujte v hladilniku (2°C -8 °C)
English: Vaccination schedule: Primary vaccination course
Slovenian: Shema cepljenja: Osnovno cepljenje
English: Administer 1 ml of vaccine intramuscularly.
Slovenian: Vbrizgajte 1 ml cepiva intramuskularno.
English: This will lead to a passive protection against tetanus for at least 21 days after concurrent administration.
Slovenian: To vzbuja pasivno zaščito pred tetanusom,ki traja najmanj 21 dni po sočasnem dajanju.
English: THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
Slovenian: BESEDILO “SAMO ZA ŽIVALI” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, ČE JE NAVEDBA SMISELNA
English: Pain at the injection site can occur in rare cases which may result in temporary functional discomfort (stiffness).
Slovenian: Na mestu dajanja se lahko pojavi bolečina, ki ima lahko za posledico začasno funkcionalno nelagodje (otrdelost).
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 voljona spletni strani Evropske agencije za zdravila (European Medicines Agency, http:/ema.europa.eu).
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use
Slovenian: NAČIN IN POT(I) UPORABE Intramuskularna uporaba
English: In case of increased infection risk or insufficient colostrum intake, an additional initial injection can be given at the age of 4 months followed by the full vaccination programme (primary vaccination course at 6 months of age and 4 weeks later)
Slovenian: Kadar je povečana ogroženost zaradi okužbe ali premajhnega vnosa kolostruma, lahko pri starosti 4 mesecev damo dodatni odmerek in nato izvedemo poln program cepljenja (osnovno cepljenje pri starosti 6 mesecev in 4 tedne pozneje).
English: 24 months after the first revaccination
Slovenian: 24 mesecev po prvi revakcinaciji
English: Special precautions for use in animals: Only healthy animals should be vaccinated.
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih Cepimo samo zdrave živali.
English: In that case, the first dose (V1) of vaccine can be given concurrently with the appropriate prophylactic dose of Tetanus-Serum at a separate injection site, using separate syringes and needles.
Slovenian: V tem primeru lahko damo prvi odmerek (C1) cepiva sočasno z ustreznim profilaktičnim odmerkom Tetanus-Seruma na drugo mesto in z različnimi brizgami in iglami.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Slovenian: Posebni varnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer
Slovenian: Wim de Körverstraat 35 5831 AN Boxmeer
English: V4
Slovenian: C4
English: Special warnings for each target species:
Slovenian: Posebna opozorila za vsako živalsko vrsto
English: Purified Saponin
Slovenian: Prečiščeni saponin
English: potency test
Slovenian: preskusu potentnosti Dodatki
English: Administer one dose (1ml), by intramuscular injection, according to the following schedule: • Primary vaccination course: first injection from 6 months of age, second injection 4 weeks later
Slovenian: Po en odmerek (1 ml) intramuskularno po naslednji shemi: • Osnovno cepljenje: prvi odmerek po 6 mesecu starosti, drugi odmerek 4 tedne pozneje.