FrancophonIA/ELRC3.0 huggingface dataset:
English: • Transient increase in serum creatinine may be greater in patients with underlying impaired renal function.
Estonian: - Olemasoleva neerufunktsiooni häirega patsientidel võib mööduv vere kreatiniinisisalduse tõus olla suurem.
English: One vial contains 4 mg zoledronic acid (as monohydrate).
Estonian: Üks viaal sisaldab 4 mg zoledroonhapet (monohüdraadina).
English: As a consequence of low calcium values: irregular heart beat (cardiac arrhythmia; secondary to hypocalcaemia).
Estonian: Bradükardia, südame arütmia (sekundaarne hüpokaltseemiale)
English: Instructions for preparing reduced doses of Zoledronic Acid Hospira: Withdraw the appropriate volume of the liquid concentrate, as follows: - 4.4 ml for 3.5 mg dose
Estonian: Juhend vähendatud annusega Zoledronic Acid Hospira lahuse valmistamiseks: Võtke vajalik kogus kontsentraati:
English: One bag with 100 ml contains 4 mg zoledronic acid (as monohydrate).
Estonian: Üks 100 ml kott sisaldab 4 mg zoledroonhapet (monohüdraadina).
English: Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving zoledronic acid for the treatment of postmenopausal osteoporosis.
Estonian: Post-menopausaalse osteoporoosi raviks zoledroonhapet saanud patsientidel on täheldatud ebaregulaarset südame fibrillatsiooni (kodade fibrillatsiooni).
English: One ml solution contains 0.04 mg zoledronic acid (as monohydrate).
Estonian: Üks ml lahust sisaldab 0,04 mg zoledroonhapet (monohüdraadina).
English: Zoledronic Acid Hospira 5 mg/100 ml solution for infusion Zoledronic acid
Estonian: Zoledronic Acid Hospira 5 mg/100 ml infusioonilahus Zoledroonhape
English: Osteonecrosis Osteonecrosis of the jaw
Estonian: Osteonekroos Lõualuu osteonekroos
English: - Zoledronic Acid Hospira is ready for use.
Estonian: Kuidas Zoledronic Acid Hospira't ette valmistada ja manustada - Zoledronic Acid Hospira on valmis kasutamiseks.
English: Osteonecrosis of the jaw has been reported uncommonly in clinical trials and in the post-marketing setting in patients receiving zoledronic acid.
Estonian: Zoledroonhappega ravitud patsientidel on kliinilistes uuringutes ja turuletulekujärgselt teatatud lõualuu osteonekroosist.
English: - 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.
Estonian: - kui teile tehakse hambaravi või on plaanis teha hambaoperatsioon, teavitage hambaarsti
English: 3.0 mg* zoledronic acid
Estonian: 4,0 mg zoledroonhapet
English: Uncommon: Blurred vision, scleritis and orbital inflammation Rare
Estonian: Hägune nägemine, skleriit ja silmakoopa põletik
English: Zoledronic Acid Hospira 4 mg/5 ml concentrate for solution for infusion
Estonian: Zoledronic Acid Hospira 4 mg/5 ml infusioonilahuse kontsentraat
English: − Keep Zoledronic Acid Hospira out of the reach and sight of children.
Estonian: - Zoledronic Acid Hospira't tuleb hoida laste eest varjatud ja kättesaamatus kohas.
English: Unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely.
Estonian: Harv (võivad esineda kuni ühel inimesel 1000-st) Harva võib esineda ebatüüpiline reieluu murd, peamiselt osteoporoosi tõttu pika-ajalist ravi saavatel patsientidel.
English: - Zoledronic Acid Hospira 4 mg/100 ml solution for infusion can be used immediately without further preparation for patients with normal renal function.
Estonian: - Normaalse neerufunktsiooniga patsientide puhul tohib Zoledronic Acid Hospira 4 mg/100 ml infusioonilahust kasutada kohe, ilma täiendava ettevalmistuseta.
English: Allow the refrigerated solution to reach room temperature before administration.
Estonian: Laske külmikus hoitud lahusel enne manustamist seista, kuni see saavutab toatemperatuuri.
English: − As a consequence of low calcium values: seizures, numbness and tetany (secondary to hypocalcaemia).
Estonian: Väga harv (võivad esineda kuni ühel inimesel 10 000-st): - Vähenenud kaltsiumi taseme tulemusena: krambid, tuimus ja tetaania (sekundaarselt hüpokaltseemiale).
English: - From a microbiological point of view, the product should be used immediately.
Estonian: - Mikrobioloogilisest saastatuse vältimiseks tuleb ravim kohe ära kasutada.
English: Zoledronic Acid Hospira 4 mg/5 ml concentrate for solution for infusion Zoledronic acid
Estonian: Zoledronic Acid Hospira 4 mg/5 ml infusioonilahuse kontsentraat Zoledroonhape
English: − Headache and a flu-like syndrome consisting of fever, fatigue, weakness, drowsiness, chills and bone, joint and/or muscle ache.
Estonian: Palavik, gripitaoline sündroom (sh väsimus, külmavärinad, halb enesetunne ja õhetus)
English: In patients who show evidence of renal deterioration during treatment, zoledronic acid should be withheld.
Estonian: Kui zoledroonhappe ravi jooksul neerupuudulikkus süveneb, tuleb ravi katkestada.
English: Each bag with 100 ml of solution contains 5 mg zoledronic acid (as monohydrate).
Estonian: Üks kott 100 ml lahusega sisaldab 5 mg zoledroonhapet (monohüdraadina).
English: Sodium citrate Sodium chloride Water for injections
Estonian: Mannitool Naatriumtsitraat Naatriumkloriid Süstevesi
English: Osteonecrosis of the external auditory canal
Estonian: Väliskuulmekanali osteonekroos
English: Table 3: Efficacy results (prostate cancer patients receiving hormonal therapy)
Estonian: Tabel 3: Efektiivsustulemused (hormoonravi saavad prostata vähiga patsiendid) Kõik LST (+TIH)
English: tremor, syncope, dysgeusia
Estonian: Letargia, paresteesia, unisus, treemor, sünkoop, düsgeusia
English: One ml of the solution contains 0.04 mg zoledronic acid (as monohydrate).
Estonian: Üks milliliiter lahust sisaldab 0,04 mg zoledroonhapet (monohüdraadina).
English: Follow all instructions given to you by your doctor, pharmacist or nurse carefully before you are given Zoledronic Acid Hospira.
Estonian: Enne Zoledronic Acid Hospira manustamist järgige hoolikalt kõiki arsti, apteekri või meditsiiniõe ettekirjutusi.
English: One bag contains 4 mg of zoledronic acid (as monohydrate).
Estonian: Üks kott sisaldab 4 mg zoledroonhapet (monohüdraadina).
English: BPI mean change from baseline
Estonian: BPI keskmine muutus algväärtuse suhtes
English: Patients should have their serum creatinine levels assessed prior to each dose of zoledronic acid.
Estonian: Enne iga zoledroonhappe annuse manustamist tuleb määrata patsiendi seerumi kreatiniinisisaldus.
English: Common Nausea, vomiting, diarrhoea Uncommon Dyspepsia, abdominal pain upper, abdominal pain, gastroesophageal reflux disease, constipation, dry mouth, oesophagitis, toothache, gastritis Skin and subcutaneous tissue disorders Uncommon Rash, hyperhidrosis, pruritus, erythema Musculoskeletal and connective tissue Common Myalgia, arthralgia, bone pain, back pain,
Estonian: Düspepsia, ülakõhuvalu, kõhuvalu, gastroösofageaalne reflukshaigus, kõhukinnisus, suukuivus, ösofagiit, hambavalu, gastriit
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.
Estonian: Enne Zoledronic Acid Hospira'ga ravi alustamist tuleb arsti, apteekrit või meditsiiniõde teavitada, kui - teil on esinenud probleeme hammaste või suuõõnega, näiteks puudulik suuhügieen,
English: Placebo zoledronic acid
Estonian: Acidum zoledronicum
English: Adequate calcium and vitamin D intake are recommended in association with zoledronic acid administration.
Estonian: Zoledroonhappe ravi ajal on soovitatav võtta piisavas koguses kaltsiumi ja D-vitamiini preparaate.
English: Osteonecrosis of the jaw (ONJ)
Estonian: Platseebo Δ Zoledroonhape 
English: Zoledronic Acid Hospira may work for longer than one year, and your doctor will let you know if you need to be treated again.
Estonian: Zoledronic Acid Hospira võib toimida kauem kui üks aasta.
English: NR
Estonian: B.
English: Zoledronic acid is contraindicated in breast-feeding women (see section 4.3).
Estonian: Rinnaga toitmise ajal on zoledroonhape vastunäidustatud (vt lõik 4.3).
English: 90 (3 x 30) tablets
Estonian: 90 (3 x 30)
English: 30 tablets
Estonian: polümeerikattega tablett
English: ATCvet code: QI02AB17.
Estonian: ATCvet kood: QI02 AB17 .
English: One dose (2 ml) contains:
Estonian: Üks annus (2 ml) sisaldab:
English: Under these circumstances, appropriate and rapid symptomatic treatment should be administered.
Estonian: Sellise olukorra tekkimisel tuleb kiiresti rakendada sobivat sümptomaatilist ravi.
English: Date of first authorisation: 11/02/2009 Date of last renewal: 10/02/2014
Estonian: Esmase müügiloa väljastamise kuupäev: 11/02/2009 Müügiloa viimase uuendamise kuupäev: 10/02/2014
English: The full immunisation program should be repeated with each gestation.
Estonian: Täielikku immuniseerimisprogrammi tuleb korrata iga tiinuse ajal.
English: Cattle (cows and heifers).
Estonian: Veis (lehm ja mullikas).
English: Zero days.
Estonian: Null päeva.
English: Very rare adverse reactions:
Estonian: Väga harvad kõrvaltoimeid:
English: A third dose should be administered 2 months thereafter.
Estonian: Kolmas annus tuleks manustada 2 kuud pärast esimest.
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.
Estonian: Seetõttu tuleb otsus selle vaktsiini kasutamiseks enne või pärast mingit muud veterinaarravimit teha iga kord eraldi.
English: The full immunisation scheme induces immunity from approximately day 13 after the first injection until approximately day 78 after the third injection.
Estonian: Täielik immunisatsiooniskeem tekitab immuunsuse ligikaudu alates 13. päevast pärast esimest süsti kuni ligikaudu 78. päevani pärast kolmandat süsti.
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.
Estonian: Immuniseerimist tuleb kaaluda ühe komponendina mastiidi tõrje kompleksprogrammist, mis tegeleb kõigi oluliste udara tervise faktoritega (st lüpsmistehnika, kinnijätmise ja tõuaretuse juhtimine, hügieen, toitumine, hoone, allapanu, lehmade mugavus, õhu ja vee puhtus, tervise jälgimine) ja muude praktiliste tegevustega.
English: Withdrawal period: Zero days.
Estonian: Keeluajad: null päeva.
English: Laboratorios Hipra, S.A. (CIAMER) Carretera C-63, km 48.300, Polígono Industrial El Rieral 17170 Amer (Girona) Spain
Estonian: Laboratorios Hipra, S.A. (CIAMER) Carretera C-63, km 48.300, Polígono Industrial El Rieral 17170 Amer (Girona) Hispaania
English: Shelf life of the veterinary medicinal product as packaged for sale: 18 months.
Estonian: Müügipakendis veterinaarravimi kõlblikkusaeg: 18 kuud.
English: In some cases, there may also be pain at the inoculation site that spontaneously subsides in a maximum of 4 days.
Estonian: Mõnel juhul võib süstimiskohas esineda ka valu, mis kaob iseenesest maksimaalselt 4 päeva jooksul.
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Estonian: Andmed antud vaktsiini ohutuse ja efektiivsuse kohta selle kasutamisel samaaegselt teiste veterinaarravimitega puuduvad.
English: Benzyl alcohol: 21 mg.
Estonian: Bensüülalkohol: 21 mg
English: They would mainly be: swelling (up to 5 cm2 on average), which disappears within 1 or 2 weeks at most.
Estonian: Nendeks on peamiselt: turse (keskmiselt kuni 5 cm2), mis kaob maksimaalselt 1 kuni 2 nädalaga.
English: Shake before use.
Estonian: Enne kasutamist loksutada.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Estonian: Ärge kasutage seda ravimit pärast kõlblikkusaega, mis on märgitud etiketil pärast Kõlblik kuni.
English: The injections should be preferably administered on the alternate sides of the neck.
Estonian: Süstid tuleb eelistatavalt teha vaheldumisi kaela ühele ja teisele küljele.
English: Store and transport refrigerated (2 °C - 8 °C) and protected from light.
Estonian: Hoida ja transportida külmas (2 °C-8 °C) ja valguse eest kaitstult.
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).
Estonian: Manustada üks annus (2ml) sügava süstiga kaelalihastesse 45 päeva enne oodatava poegimise tähtaega ning 1 kuu pärast manustada teine annus (vähemalt 10 päeva enne poegimist).
English: Liquid paraffin: 18.2 mg
Estonian: Vedel parafiin: 18,2 mg
English: The whole herd should be immunised.
Estonian: Immuniseerida tuleb kogu kari.
English: Disposal: read package leaflet.
Estonian: Hävitamine: lugeda pakendi infolehte.
English: Pharmacotherapeutic group: Immunologicals for bovidae, inactivated bacterial vaccines for cattle.
Estonian: Farmakoterapeutiline rühm: Immunoloogilised preparaadid veislastele, inaktiveeritud bakteriaalsed vaktsiinid veistele.
English: Ivory-coloured homogeneous emulsion.
Estonian: Elevandiluuvärvi homogeenne emulsioon.
English: Accidental injection is dangerous - read the package leaflet before use.
Estonian: Juhuslik süstimine iseendale on ohtlik - enne kasutamist lugeda pakendi infolehte.
English: One dose contains: E. coli J5 inactivated; S. aureus (CP8) strain SP 140 inactivated.
Estonian: Üks annus sisaldab: E. coli J5 inaktiveeritud; S. aureus (CP8) tüvi SP140 inaktiveeritud.
English: 4.7 Use during pregnancy, lactation or lay
Estonian: 4.7 Kasutamise tiinuse, laktatsiooni või munemise perioodil
English: 17170 Amer (Girona) SPAIN
Estonian: 17170- AMER (Girona) HISPAANIA
English: Type I colourless glass vials of 3, 10 and 50 ml.
Estonian: I tüüpi värvitust klaasist viaalid suurustes 3, 10 ja 50 ml.
English: Tel. +34 972 430660 Fax +34 972 430661 E-mail: hipra@hipra.com
Estonian: Faks: +34 972 430661 E-post: hipra@hipra.com
English: E. coli J5 inactivated > 50 RED60 (Rabbit effective dose in 60% of the animals (serology)).
Estonian: E. coli J5 inaktiveeritud > 50 RED60 (Küüliku efektiivne annus 60 %-l loomadest (seroloogia)).
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)
Estonian: 1 viaal 1 annusega (2 ml) 10 viaali 1 annusega (2 ml) 20 viaali 1 annusega (2 ml) 1 viaal 5 annusega (10 ml) 10 viaali 5 annusega (10 ml) 1 viaal 25 annusega (50 ml) 10 viaali 25 annusega (50 ml) 1 viaal 125 annusega (250 ml) 125 annusega (250 ml)
English: Allow the vaccine to reach a temperature of 15 °C to 25 °C before administration.
Estonian: Enne manustamist lasta vaktsiinil saavutada temperatuur +15 kuni + 25 °C.
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.
Estonian: Kui olete juhuslikult endale seda veterinaarravimit süstinud, võtta kaasa pakendi infoleht ja pöörduda viivitamatult arsti poole, isegi kui süstitud kogus oli väga väike.
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
Estonian: EU/2/08/092/004 1 klaasviaal 5 annusega EU/2/08/092/005 10 klaasviaali 5 annusega) EU/2/08/092/006 1 klaasviaal 25 annusega EU/2/08/092/007 10 klaasviaali 25 annusega EU/2/08/092/008 1 PET viaal 5 annusega EU/2/08/092/009 1 PET viaal 25 annusega EU/2/08/092/010 1 PET viaal 125 annusega
English: The vials are closed with a rubber stopper and aluminium cap.
Estonian: Viaalid on suletud kummikorgi ja alumiiniumist kattekorgiga.
English: To stimulate active immunity against Staphylococcus aureus, coliforms and coagulase-negative staphylococci.
Estonian: Aktiivse immuunsuse stimuleerimiseks Staphylococcus aureus'e, koliformsete bakterite ja koagulaasnegatiivsete stafülokokkide vastu.
English: 1 dose (2 ml) 5 doses (10 ml) 25 doses (50 ml)
Estonian: 1 annus (2 ml) 5 annust (10 ml) 25 annust (50 ml)
English: ** RED80: Rabbit effective dose in 80% of the animals (serology).
Estonian: ** RED80: Küüliku efektiivne annus 80 %-l loomadest (seroloogia).
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Estonian: Kõrvaltoimete esinemissagedus on defineeritud järgnevalt: - Väga sage (kõrvaltoime(d) ilmnes(id) rohkem kui 1-l loomal10-st ravitud loomast)) - Sage (rohkem kui 1-l, kuid vähem kui 10 loomal 100-st ravitud loomast) - Aeg-ajalt (rohkem kui 1-l, kuid vähem kui 10-l loomal 1000-st ravitud loomast) - Harv (rohkem kui 1-l, kuid vähem kui 10 loomal 10,000-st ravitud loomast) - Väga harv (vähem kui 1-l loomal 10,000-st ravitud loomast,, kaasaarvatud üksikjuhud).
English: Benzyl alcohol…………….......................................................... 21 mg. For the full list of excipients, see section 6.1.
Estonian: Bensüülalkohol…………….......................................................... 21 mg Abiainete täielik loetelu on esitatud punktis 6.1.
English: S. aureus (CP8) strain SP 140 inactivated, expressing slime associated antigenic complex (SAAC) > 50 RED80 (In 80% of the animals).
Estonian: S. aureus (CP8) tüvi SP140 inaktiveeritud, ekspresseerib SAAC (slime associated antigenic complex) kompleksi > 50 RED80 (80 %-l loomadest).
English: Batch{number}
Estonian: Partii {number}
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.
Estonian: - Müügiloajärgse ravimijärelevalve aruandluse põhjal võib esimese 24 tunni jooksul pärast süsti esineda mööduv kehatemperatuuri tõus keskmiselt umbes 1 °C võrra, mõnel lehmal kuni 2 °C võrra.
English: 4.4 Special warnings for each target species
Estonian: 4.4 Erihoiatused <iga loomaliigi kohta>
English: STARTVAC is an ivory-coloured homogeneous emulsion for injection.
Estonian: STARTVAC on elevandiluuvärvi homogeenne süsteemulsioon.
English: Escherichia coli (J5) inactivated .......................................................................... > 50 RED60* Staphylococcus aureus (CP8) strain SP 140 inactivated, expressing slime associated antigenic complex (SAAC)........................................................................ ........................................ > 50 RED80** * RED60: Rabbit effective dose in 60% of the animals (serology).
Estonian: Escherichia coli (J5) inaktiveeritud...................................................................... > 50 RED60* Staphylococcus aureus (CP8) tüvi SP140 inaktiveeritud, ekspresseerib SAAC (slime associated antigenic complex) kompleksi ............................. ................................................ > 50 RED80** * RED60: Küüliku efektiivne annus 60 %-l loomadest (seroloogia).
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.
Estonian: Tervete lehmade ja mullikate vaktsineerimiseks retsidiveeruvate mastiidiprobleemidega piimakarjades, et vähendada Staphylococcus aureus'e, Koliformsed bakterid ja koagulaasnegatiivsete stafülokokkide poolt põhjustatud subkliinilise mastiidi esinemissagedust ning kliinilise mastiidi esinemissagedust ja kliiniliste sümptomite raskust.
English: Polyethylene (PET) vials of 10, 50 and 250 ml.
Estonian: Polüetüleenist (PET) viaalid suurustes 10, 50 ja 250 ml.
English: No adverse reactions other than those mentioned in section 4.6 were observed after the administration of a double dose of vaccine.
Estonian: Vaktsiini topeltannuse manustamise järgselt ei esinenud muid kõrvaltoimeid peale nende, mis on kirjas lõigus 4.6.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Estonian: A. BIOLOOGILIS(T)E TOIMEAINE(TE) TOOTJA(D) JA RAVIMIPARTII KASUTAMISEKS VABASTAMISE EEST VASTUTAVAD TOOTJA<D
English: Shelf life after first opening the immediate packaging: 10 hours stored at 15 °C to 25 ºC.
Estonian: Kõlblikkusaeg pärast vahetu pakendi esmast avamist: 10 tundi säilitamisel temperatuuril +15 kuni +25 ºC.
English: - Anaphylactic-type reactions may occur in some sensitive animals which might be life-threatening based on post-authorisation pharmacovigilance reporting.
Estonian: - Müügiloajärgse ravimijärelevalve aruandluse põhjal võivad mõnedel tundlikumatel loomadel esineda anafülaktilist tüüpi reaktsioonid ning need võivad olla eluohtlikud.
English: Liquid paraffin.............................................................................. 18.2 mg
Estonian: Vedel parafiin.............................................................................. 18,2 mg
English: Marketing authorisation holder and manufacturer responsible for batch release:
Estonian: Müügiloa hoidja ja tootja:
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Estonian: Vaktsineerige ainult terveid loomi Ettevaatusabinõud veterinaarravimit loomale manustavale isikule
English: - Slight to moderate transient local reactions may occur after the administration of one dose of vaccine based on post-authorisation pharmacovigilance reporting.
Estonian: - Müügiloajärgse ravimijärelevalve aruandluse põhjal võivad pärast ühe vaktsiiniannuse manustamist esineda kerged kuni mõõdukad mööduvad lokaalsed reaktsioonid.
English: WITHDRAWAL PERIODS
Estonian: KEELUAEG
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard boxes, PET vial (250 ml)
Estonian: Pappkarbid, PET-viaaliga (250 ml)
English: EU/2/08/092/009 1 PET vial of 25 doses EU/2/08/092/010 1 PET vial of 125 doses
Estonian: EU/2/08/092/001 1 klaasviaal 1 annusega EU/2/08/092/002 10 klaasviaali 1 annusega EU/2/08/092/003 20 klaasviaali 1 annusega
English: Benzyl alcohol Liquid paraffin Sorbitan monooleate Polysorbate 80
Estonian: FARMATSEUTILISED ANDMED 6.1 Abiainete loetelu bensüülalkohol vedel parafiin sorbitaanmonooleaat polüsorbaat 80 naatriumalginaat kaltsiumkloriiddihüdraat simetikoon süstevesi
English: No adverse reactions other than those mentioned in section “Adverse reactions” were observed after the administration of a double dose of vaccine.
Estonian: Vaktsiini topeltannuse manustamise järgselt ei esinenud muid kõrvaltoimeid peale nende, mis on kirjas lõigus “Kõrvaltoimed”.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Estonian: PAKENDI INFOLEHT STARTVAC süsteemulsioon veistele MÜÜGILOA HOIDJA NING, KUI NEED EI KATTU, RAVIMIPARTII VÄLJASTAMISE EEST VASTUTAVA TOOTMISLOA HOIDJA NIMI JA AADRESS
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)
Estonian: PET-viaalid (10 ml, 50 ml) ja klaasviaalid (2 ml, 10 ml, 50 ml)
English: STARTVAC emulsion for injection for cattle
Estonian: STARTVAC süsteemulsioon veistele.
English: Cardboard box with 10 glass vials of 25 doses.
Estonian: - pappkarp 10 klaasviaaliga, mis sisaldavad 25 annust.