FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor may recommend a dental examination before you start treatment with Zoledronic Acid Hospira - if you are having dental treatment or are due to undergo dental surgery, tell your dentist that you are being treated with Zoledronic Acid Hospira and inform your doctor about your dental treatment.
Slovenian: - če vam zobozdravnik začne zdraviti zobe ali boste imeli stomatološko operacijo, mu povejte, da prejemate zdravilo Zoledronska kislina Hospira in obvestite svojega zdravnika o zdravljenju zob.
English: How Zoledronic Acid Hospira is given - Zoledronic Acid Hospira is given as a drip (infusion) into a vein which should take at least 15 minutes and should be administered as a single intravenous solution in a separate infusion line.
Slovenian: Kako se daje zdravilo Zoledronska kislina Hospira - Zdravilo Zoledronska kislina Hospira dobijo bolniki v obliki infuzije v veno, ki naj traja vsaj
English: The start of treatment or of a new course of treatment should be delayed in patients with unhealed open soft tissue lesions in the mouth.
Slovenian: Pri bolnikih z nezaceljenimi odprtimi lezijami mehkih tkiv v ustih je treba začetek zdravljenja oziroma ponovno aplikacijo zdravila odložiti.
English: Remove the volume of Zoledronic Acid Hospira solution indicated from the bag prior to administration.
Slovenian: Pred dajanjem odstranite iz vreče navedeno količino raztopine zdravila Zoledronska kislina Hospira.
English: You should not be given Zoledronic Acid Hospira if you are pregnant.
Slovenian: Če ste noseči, ne smete dobivati zdravila Zoledronska kislina Hospira.
English: − Keep Zoledronic Acid Hospira out of the reach and sight of children.
Slovenian: − Zdravilo Zoledronska kislina Hospira shranjujte nedosegljivo otrokom!
English: Additionally, there have been sporadic reports of osteonecrosis of other sites, including the hip and femur, reported predominantly in adult cancer patients treated with Zoledronic Acid Hospira.
Slovenian: O teh primerih so poročali predvsem pri odraslih bolnikih z rakom, ki so se zdravili z zdravilom Zoledronska kislina Hospira.
English: Each bag with 100 ml of solution contains 4 mg zoledronic acid (as monohydrate).
Slovenian: Ena vreča s 100 ml raztopine vsebuje 4 mg zoledronske kisline (v obliki monohidrata).
English: Monitoring test
Slovenian: Preiskave za spremljanje bolnika
English: Each bag of 100 ml contains 5 mg zoledronic acid (as monohydrate).
Slovenian: Ena vreča s 100 ml vsebuje 5 mg zoledronske kisline (v obliki monohidrata).
English: Uveitis, episcleritis, iritis
Slovenian: dispneja, kašelj, bronhokonstrikcija
English: Talk to your doctor before being given Zoledronic Acid Hospira:
Slovenian: Opozorila in previdnostni ukrepi Preden dobite zdravilo Zoledronska kislina Hospira, se posvetujte z zdravnikom:
English: One bag contains 4 mg of zoledronic acid (as monohydrate).
Slovenian: Ena vreča vsebuje 4 mg zoledronske kisline (v obliki monohidrata).
English: − if you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: − Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: TIH:
Slovenian: Občasni:
English: Table 2: Efficacy results (prostate cancer patients receiving hormonal therapy) Any SRE (+TIH)
Slovenian: Preglednica 2: Rezultati učinkovitosti (bolniki z rakom prostate, ki so prejemali hormonsko zdravljenje)
English: Uncommon: Thrombocytopenia, leukopenia Rare:
Slovenian: trombocitopenija, levkopenija
English: Serum calcium should be measured and hypocalcaemia must be corrected before initiating zoledronic acid therapy.
Slovenian: Pred začetkom zdravljenja z zoledronsko kislino je treba izmeriti vrednost kalcija v serumu in odpraviti morebitno hipokalciemijo.
English: Each bag with 100 ml of solution contains 5 mg zoledronic acid (as monohydrate).
Slovenian: Ena vreča s 100 ml raztopine vsebuje 5 mg zoledronske kisline (v obliki monohidrata).
English: Unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely.
Slovenian: Redki (lahko se pojavijo pri največ 1 od 1.000 bolnikov) Redko se lahko pojavijo neobičajni zlomi stegnenice, še posebno pri bolnikih, ki so na dolgotrajnem zdravljenju osteoporoze.
English: Zoledronic Acid Hospira 5 mg/100 ml (to appear in roundel) solution for infusion Zoledronic acid
Slovenian: Zoledronska kislina Hospira 5 mg/100 ml (na okencu) raztopina za infundiranje zoledronska kislina intravenska uporaba
English: Psychiatric disorders Uncommon: Anxiety, sleep disturbance
Slovenian: Psihiatrične motnje občasni nespečnost
English: This is because you may develop serum electrolyte abnormalities (e.g. abnormal levels of calcium, phosphorus and magnesium) and/or changes in kidney function, including severe kidney impairment.
Slovenian: Če ste prejeli večji odmerek zdravila Zoledronska kislina Hospira, kot bi smeli Če ste prejeli odmerek, ki je večji od priporočenega, vas mora zdravnik natančno nadzorovati, zato ker lahko pride do nepravilnosti elektrolitov v serumu (do nepravilnih koncentracij kalcija, fosforja in magnezija) in/ali do spremenjenega delovanja ledvic, vključno z ledvično odpovedjo.
English: Zoledronic Acid Hospira 4 mg/100 ml (to appear in roundel) solution for infusion Zoledronic acid
Slovenian: Zoledronska kislina Hospira 4 mg/100 ml (v okencu) raztopina za infundiranje zoledronska kislina intravenska uporaba
English: p-value
Slovenian: vrednost p 0,003
English: Your doctor should do a blood test to check your kidney function before each dose of Zoledronic Acid Hospira.
Slovenian: Zdravnik mora pred vsakim odmerjanjem zdravila Zoledronska kislina Hospira s krvnimi preiskavami pregledati delovanje vaših ledvic.
English: NA Not Applicable
Slovenian: NA ne velja za ta primer
English: In most cases no specific treatment is required and the symptoms disappear after a short time (couple of hours or days).
Slovenian: V večini primerov ni potrebno nikakršno specifično zdravljenje in simptomi v kratkem (čez nekaj ur ali dni)izzvenijo, reakcije prebavil, na primer slabost s siljenjem na bruhanje (navzea) in bruhanje,pa tudi izguba teka, konjunktivitis, nizka koncentracija rdečih krvnih celic (anemija).
English: - Any other medicines that contain zoledronic acid which is used to treat osteoporosis and other noncancer diseases of the bone, or any other bisphosphonate, since the combined effects of these medicines taken together with Zoledronic Acid Hospira are unknown.
Slovenian: Bolniki, ki prejemajo zdravilo Zoledronska kislina Hospira, ne smejo sočasno prejemati teh zdravil ali katerihkoli drugih difosfonatov, saj ni znano, kako navedena zdravila delujejo v kombinaciji.
English: Table 5: Efficacy results (breast cancer and multiple myeloma patients)
Slovenian: Preglednica 5: Rezultati učinkovitosti (bolnice/bolniki z rakom dojke in multiplim mielomom) Katerikoli SRE (+TIH)
English: You may eat normally on the day you are treated with Zoledronic Acid Hospira.
Slovenian: Na dan, ko dobite zdravilo Zoledronska kislina Hospira, lahko normalno jeste.
English: Radiation therapy to bone zoledronic acid
Slovenian: Zdravljenje kosti z obsevanjem zoledronska kislina 4 mg placebo zoledronska kislina
English: Treatment of TIH
Slovenian: NAČIN IZDAJANJA ZDRAVILA
English: Common Ocular hyperaemia Uncommon Conjunctivitis, eye pain Rare
Slovenian: Očesne bolezni pogosti očesna hiperemija občasni konjunktivitis, bolečina v očesu redki uveitis, episkleritis, iritis pogostnost neznana**
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora občasni kašelj, dispneja
English: Uncommon: Acute renal failure, haematuria, proteinuria Rare
Slovenian: akutna odpoved ledvic, hematurija, proteinurija
English: Zoledronic Acid Hospira is not recommended for use in adolescents and children below the age of 18 years.
Slovenian: Pri otrocih in mladostnikih, ki so stari manj kot 18 let, uporaba zdravila Zoledronska kislina Hospira ni priporočljiva.
English: 90 (3 x 30) tablets
Slovenian: 90 (3 x 30) tablet
English: Protect from light.
Slovenian: Zaščitite pred svetlobo
English: Under these circumstances, appropriate and rapid symptomatic treatment should be administered.
Slovenian: Če pride do tega je treba uporabiti ustrezno in hitro simptomatično zdravljenje.
English: Very rare adverse reactions:
Slovenian: Zelo redki neželeni učinki:
English: Cattle (cows and heifers).
Slovenian: govedo (krave in telice).
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: The full immunisation program should be repeated with each gestation.
Slovenian: Celoten program imunizacije naj se ponovi ob vsaki brejosti.
English: A third dose should be administered 2 months thereafter.
Slovenian: Tretji odmerek je treba vbrizgati čez 2 meseca.
English: Date of first authorisation: 11/02/2009 Date of last renewal: 10/02/2014
Slovenian: Datum zadnjega podaljšanja dovoljenja za promet: 10/02/2014
English: Immunisation has to be considered as one component in a complex mastitis control program that addresses all important udder health factors (e.g. milking technique, dry-off and breeding management, hygiene, nutrition, housing, bedding, cow comfort, air and water quality, health monitoring) and other management practices.
Slovenian: Imunizacijo je treba razumeti kot enega od sestavnih delov v kompleksnem programu kontrole mastitisa, ki vključuje vse faktorje, pomembne za zdravo vime (kot so npr. tehnika molže, upravljanje presušitev in vzreje, higiena, hrana, nastanitev, nastilj, udobnost krav, kakovost zraka in vode, nadzor zdravja), in druge načine upravljanja.
English: The full immunisation scheme induces immunity from approximately day 13 after the first injection until approximately day 78 after the third injection.
Slovenian: Imunizacija po celotnem programu zagotovlja imunost približno od 13 dne od prvega injiciranja do približno 78 dne po tretjem injiciranju.
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Slovenian: O uporabi tega cepiva pred ali po kakem drugem zdravilu za uporabo v veterinarski medicini je zatorej treba odločati od primera do primera.
English: ATCvet code: QI02AB17.
Slovenian: Oznaka ATCvet: QI02 AB17
English: They would mainly be: swelling (up to 5 cm2 on average), which disappears within 1 or 2 weeks at most.
Slovenian: V večini primerov je to oteklina (povprečno do 5 cm2), ki izgine po 1 ali največ 2 tednih.
English: The injections should be preferably administered on the alternate sides of the neck.
Slovenian: Po možnosti naj se zdravilo injiciranja izmenoma na obeh straneh vratu.
English: In some cases, there may also be pain at the inoculation site that spontaneously subsides in a maximum of 4 days.
Slovenian: V nekaterih primerih je lahko na mestu cepljenja prisotna bolečina, ki sama od sebe popusti po največ 4 dneh.
English: Vaccinate healthy animals only.
Slovenian: Cepite samo zdrave živali
English: The whole herd should be immunised.
Slovenian: Imunizira naj se celotno čredo.
English: Administer one dose (2 ml) by deep intramuscular injection in the neck muscles at 45 days before the expected parturition date and 1 month thereafter administer a second dose (at least 10 days before calving).
Slovenian: Z globoko intramuskularno injekcijo vbrizgajte v vratno mišico en odmerek (2 ml) 45 dni pred pričakovanim datumom poroda in 1 mesec nato vbrizgajte drug odmerek (najmanj 10 dni pred porodom).
English: Sodium alginate Calcium chloride, dihydrate Simeticone
Slovenian: natrijev alginat kalcijev klorid dihidrat simetikon voda za injekcije
English: The vials are closed with a rubber stopper and aluminium cap.
Slovenian: Viale so zaprte z gumijastim zamaškom in aluminijasto zaporko.
English: Store and transport refrigerated (2 °C - 8 °C) and protected from light.
Slovenian: Shranjujte in prevažajte v hladilniku (2°C do 8°C) in zaščitite pred svetlobo.
English: Name and address of the manufacturer of the biological active substances
Slovenian: Ime in naslov izdelovalca bioloških zdravilnih učinkovin.
English: Pharmacotherapeutic group: Immunologicals for bovidae, inactivated bacterial vaccines for cattle.
Slovenian: Farmakoterapevtska skupina: Imunološki izdelek za votloroge (Bovidae), inaktivirano bakterijsko cepivo za govedo.
English: One dose contains: E. coli J5 inactivated; S. aureus (CP8) strain SP 140 inactivated.
Slovenian: En odmerek vsebuje: E. coli J5 inaktivirana; S. aureus (CP8) sev SP140 inaktiviran.
English: 1 vial of 1 dose (2 ml) 10 vials of 1 dose (2 ml) 20 vials of 1 dose (2 ml) 1 vial of 5 doses (10 ml) 10 vials of 5 doses (10 ml) 1 vial of 25 doses (50 ml) 10 vials of 25 doses (50 ml) 1 vial of 125 doses (250 ml) 125 doses (250 ml)
Slovenian: 1 viala z enim odmerkom (2 ml) 10 vial z enim odmerkom (2 ml) 20 vial z enim odmerkom (2 ml) 1 viala s 5 odmerki (10 ml) 10 vial s 5 odmerki (10 ml) 1 viala s 25 odmerki (50 ml) 10 vial s 25 odmerki (50 ml) 1 viala s 125 odmerki (250 ml) 125 odmerkov (250 ml)
English: To stimulate active immunity against Staphylococcus aureus, coliforms and coagulase-negative staphylococci.
Slovenian: Za stimulacijo aktivne imunosti proti Staphylococcus aureus, koliformnim bakterijam in proti koagulaza negativnim stafilokokom.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Slovenian: NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGEIH SESTAVIN
English: For herd immunisation of healthy cows and heifers, in dairy cattle herds with recurring mastitis problems, to reduce the incidence of sub-clinical mastitis and the incidence and the severity of the clinical signs of clinical mastitis caused by Staphylococcus aureus, coliforms and coagulase-negative staphylococci.
Slovenian: Za imunizacijo čred zdravih krav in telic, v čredah krav molznic, pri katerih se ponavlja problem mastitisa, da se zmanjša pogostnost subkliničnega mastitisa in pogostnost ter resnost kliničnih znakov kliničnega mastitisa, ki jih povzročajo Staphylococcus aureus, koliformnim bakterijam in proti koagulaza negativnim stafilokokom.
English: Benzyl alcohol Liquid paraffin Sorbitan monooleate Polysorbate 80
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi benzilalkohol parafin, tekoči sorbitan monooleat polisorbat 80
English: la Selva, 135 17170 Amer (Girona) SPAIN
Slovenian: La Selva, 135 17170 Amer (Girona) Španija
English: Polyethylene (PET) vials of 10, 50 and 250 ml.
Slovenian: Polietilenske (PET) plastenke po 10, 50 in 250 ml.
English: 1 dose (2 ml) 5 doses (10 ml) 25 doses (50 ml)
Slovenian: 1 odmerek (2 ml) 5 odmerkov (10 ml) 25 odmerkov (50 ml)
English: S. aureus (CP8) strain SP 140 inactivated, expressing slime associated antigenic complex (SAAC) > 50 RED80 (In 80% of the animals).
Slovenian: S. aureus (CP8) sev SP140 inaktiviran, izraža z antigenskim kompleksom povezano izločanje sluzi (SAAC) > 50 RED80 (pri 80 % živali).
English: If you are accidentally injected with this veterinary medicinal product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
Slovenian: Če vam jebilo to zdravilo nenamerno injicirano, se takoj posvetujte z zdravnikom, čeprav je bila injicirana le majhna količina, in mu pokažite navodilo za uporabo.
English: Allow the vaccine to reach a temperature of 15 °C to 25 °C before administration.
Slovenian: Cepivo se mora pred uporabo segreti na temperaturo med 15°C in 25°C.
English: Liquid paraffin: 18.2 mg
Slovenian: parafin, tekoči: 18,2 mg benzilalkohol: 21 mg
English: EU/2/08/092/001 1 glass vial 1 dose EU/2/08/092/002 10 glass vials 1 dose EU/2/08/092/003 20 glass vials 1 dose EU/2/08/092/004 1 glass vial 5 doses EU/2/08/092/005 10 glass vials 5 doses EU/2/08/092/006 1 glass vial 25 doses EU/2/08/092/007 10 glass vials 25 doses EU/2/08/092/008 1 PET vial of 5 doses
Slovenian: EU/2/08/092/001 1 steklena viala z enim odmerkom EU/2/08/092/002 10 steklenih vial z enim odmerkom EU/2/08/092/003 20 steklenih vial z enim odmerkom EU/2/08/092/004 1 steklena viala s 5 odmerki EU/2/08/092/005 10 steklenih vial s 5 odmerki
English: - A mean transient increase in body temperature of about 1 °C, in some cows up to 2 °C, may occur in the first 24 hours after injection based on post-authorisation pharmacovigilance reporting.
Slovenian: - Na osnovi podatkov postavtorizacijskega poročanja o neželenih učinkih lahko v prvih 24 urah po injiciranju pride do prehodnega porasta telesne temperature, ki znaša v povprečju okoli 1 °C, pri nekaterih kravah do 2 °C.
English: HIPRA EΛΛAΣ A.E. Tηλ: (+30) 210 4978660
Slovenian: Tηλ: (+30) 210 4978660
English: Ivory-coloured homogeneous emulsion.
Slovenian: Homogena emulzija, slonokoščene barve.
English: EU/2/08/092/001-010
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU/2/08/092/001-010
English: 17170 Amer (Girona) SPAIN
Slovenian: 17170 Amer (Girona) Španija
English: Store and transport refrigerated.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte in prevažajtev hladilniku .
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Slovenian: Ne uporabljajte po datumu izteka roka uporabnosti, ki je naveden na ovojnini po EXP. Rok uporabnosti zdravila se nanaša na zadnji dan v navedenem mesecu.
English: Benzyl alcohol…………….......................................................... 21 mg. For the full list of excipients, see section 6.1.
Slovenian: Benzilalkohol…………….......................................................... 21 mg
English: Special warnings for each target species: The whole herd should be immunised.
Slovenian: 4.4 Posebna opozorila za vsako ciljno živalsko vrsto Imunizira naj se celotno čredo.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard boxes, PET vial (250 ml)
Slovenian: PODATKI NA ZUNANJI OVOJNINI Kartonske škatle, PET plastenke (250 ml)
English: E. coli J5 inactivated > 50 RED60 (Rabbit effective dose in 60% of the animals (serology)).
Slovenian: En odmerek (2 ml) vsebuje: E. coli J5 inaktivirana > 50 RED60 (efektivni odmerek za zajca v 60 % živali (serologija)).
English: The active substances being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Slovenian: C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovina biološkega izvora namenjena vzbujanju aktivne imunosti, ni vključena v Uredbo(ES) št.
English: * RED60: Rabbit effective dose in 60% of the animals (serology).
Slovenian: * RED60: efektivni odmerek za kunca pri 60 % živali (serologija)
English: Type I colourless glass vials of 3, 10 and 50 ml.
Slovenian: 6.5 Vrsta ovojnine in vsebina Brezbarvne viale iz stekla tipa I po 3, 10 in 50 ml.
English: CLINICAL PARTICULARS 4.1 Target species
Slovenian: KLINIČNI PODATKI 4.1 Ciljne živalske vrste govedo (krave in telice).
English: - Anaphylactic-type reactions may occur in some sensitive animals which might be life-threatening based on post-authorisation pharmacovigilance reporting.
Slovenian: - Na osnovi podatkov postavtorizacijskega poročanja o neželenih učinkih lahko pri nekaterih občutljivih živalih pride do reakcij anafilaktičnega tipa, ki so lahko smrtno nevarne.
English: - Slight to moderate transient local reactions may occur after the administration of one dose of vaccine based on post-authorisation pharmacovigilance reporting.
Slovenian: - Na osnovi podatkov postavtorizacijskega poročanja o neželenih učinkih lahko po uporabi enega odmerka cepiva pride do rahlih do zmernih prehodnih lokalnih reakcij.
English: Laboratorios Hipra, S.A. (CIAMER) Carretera C-63, km 48.300, Polígono Industrial El Rieral 17170 Amer (Girona) Spain
Slovenian: Laboratorios Hipra, S.A. (CIAMER) Carretera C-63, km 48.300,
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. <PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE (UČINKOVIN) IN> PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: Marketing authorisation holder and manufacturer responsible for batch release:
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec odgovoren za sproščanje serij:
English: STARTVAC emulsion for injection for cattle
Slovenian: emulzija za injiciranje za govedo
English: ** RED80: Rabbit effective dose in 80% of the animals (serology).
Slovenian: ** RED80: efektivni odmerek za kunca pri 80 % živali (serologija) Dodatek:
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo: Namenjeno uporabniku:
English: Shelf life after first opening the immediate packaging: 10 hours stored at 15 °C to 25 ºC.
Slovenian: Rok uporabnosti po prvem odpiranju stične ovojnine:10 ur, če je shranjeno pri 15 ºC do 25ºC.
English: EU/2/08/092/009 1 PET vial of 25 doses EU/2/08/092/010 1 PET vial of 125 doses
Slovenian: EU/2/08/092/006 1 steklena viala s 25 odmerki EU/2/08/092/007 10 steklenih vial s 25 odmerki
English: Pack sizes: - Cardboard box with 1, 10 and 20 glass vials of 1 dose.
Slovenian: velikosti pakiranja: - kartonska škatla z 1, 10 in 20 steklenimi vialami po 1 odmerek.
English: No adverse reactions other than those mentioned in section “Adverse reactions” were observed after the administration of a double dose of vaccine.
Slovenian: Po uporabi dvojnega odmerka cepiva neželenih učinkov razen tistih, ki so navedeni v poglavju “Neželeni učinki”, ni bilo opaziti.
English: HIPRA FRANCE Tél.
Slovenian: Tél.
English: Accidental injection is dangerous - read the package leaflet before use.
Slovenian: POSEBNO(A) OPOZORILO(A), ČE JE/SO POTREBNO(A) Nenamerno injiciranje je nevarno - pred uporabo preberite navodilo za uporabo:
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PET vials (10 ml, 50 ml) and glass vials (2 ml, 10 ml, 50 ml)
Slovenian: PET plastenke (10 ml, 50 ml) in steklene viale (2 ml, 10 ml, 50 ml)
English: STARTVAC is an ivory-coloured homogeneous emulsion for injection.
Slovenian: STARTVAC homogena emulzija za injiciranje, slonokoščene barve.
English: Excipient:
Slovenian: EXP
English: No adverse reactions other than those mentioned in section 4.6 were observed after the administration of a double dose of vaccine.
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Po uporabi dvojnega odmerka cepiva neželenih učinkov razen tistih, ki so navedeni v poglavju 4.6, ni bilo opaziti.
English: Escherichia coli J5 inactivated ............................................................................. > 50 RED60* Staphylococcus aureus (CP8) strain SP 140 inactivated, expressing slime associated antigenic complex (SAAC) ............. …………………………………………… > 50 RED80**
Slovenian: Staphylococcus aureus (CP8) sev SP 140 inaktiviran, izraža z antigenskim kompleksom povezano izločanje sluzi (SAAC) ................... …………………………………………… > 50 RED80 **
English: Adjuvant:
Slovenian: Avda.
English: Liquid paraffin.............................................................................. 18.2 mg
Slovenian: Parafin, tekoči.............................................................................. 18,2 mg Pomožne snovi:
English: - Cardboard box with 1 and 10 glass vials of 5 doses.
Slovenian: - kartonska škatla z 1 in 10 steklenimi vialami po 5 odmerkov.
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov izdelovalca zdravila, odgovornega za sproščanje serije Laboratorios Hipra, S.A.
English: Cardboard box with 20 glass vials of 1 dose.
Slovenian: - katonska škatla z 20 steklenimi vialami po 1 odmerek.
English: Cardboard box with 10 glass vials of 1 dose.
Slovenian: - kartonska škatla z 10 steklenimi vialami po 1 odmerek.
English: - Cardboard box with 1 and 10 glass vials of 25 doses.
Slovenian: - kartonska škatla z 1 in 10 stekla vialami po 25 odmerkov.