FrancophonIA/ELRC3.0 huggingface dataset:
English: MARKETING AUTHORISATION NUMBERS EU/1/06/375/001-005
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/06/375/001-005
English: NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 75 mg tablets irbesartan
Estonian: RAVIMPREPARAADI NIMETUS Irbesartan BMS 75 mg tabletid irbesartaan
English: Pregnancy
Estonian: nahaõhetus
English: Name and address of the manufacturers responsible for batch release
Estonian: Ravimipartii vabastamise eest vastutava(te) tootja(te) nimi ja aadress
English: MARKETING AUTHORISATION NUMBERS EU/1/06/375/011-015
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/06/375/011-015
English: NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 150 mg tablets irbesartan
Estonian: RAVIMPREPARAADI NIMETUS Irbesartan BMS 150 mg tabletid irbesartaan
English: NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 150 mg tablets.
Estonian: RAVIMPREPARAADI NIMETUS Irbesartan BMS 150 mg tabletid.
English: PACKAGE LEAFLET: INFORMATION FOR THE USER Irbesartan BMS 150 mg tablets irbesartan
Estonian: PAKENDI INFOLEHT: INFORMATSIOON KASUTAJALE Irbesartan BMS 150 mg tabletid irbesartaan
English: Cartons of 98 tablets: 7 blister cards of 14 tablets in PVC/PVDC/Aluminium blisters.
Estonian: Karbis on 98 tabletti: 7 blistririba 14 tabletiga PVC/PVDC/alumiinium blistris.
English: Cartons of 56 tablets: 4 blister cards of 14 tablets in PVC/PVDC/Aluminium blisters.
Estonian: Karbis on 56 tabletti: 4 blistririba 14 tabletiga PVC/PVDC/alumiinium blistris.
English: PACKAGE LEAFLET: INFORMATION FOR THE USER Irbesartan BMS 300 mg tablets irbesartan
Estonian: PAKENDI INFOLEHT: INFORMATSIOON KASUTAJALE Irbesartan BMS 300 mg tabletid irbesartaan
English: Cartons of 28 tablets: 2 blister cards of 14 tablets in PVC/PVDC/Aluminium blisters.
Estonian: Karbis on 28 tabletti: 2 blistririba 14 tabletiga PVC/PVDC/alumiinium blistris.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 300 mg tablets irbesartan
Estonian: RAVIMPREPARAADI NIMETUS Irbesartan BMS 300 mg tabletid irbesartaan
English: Cartons of 14 tablets: 1 blister card of 14 tablets in PVC/PVDC/Aluminium blisters.
Estonian: Karbis on 14 tabletti: 1 blistririba 14 tabletiga PVC/PVDC/alumiinium blistris.
English: Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred maintenance dose for the treatment of associated kidney disease.
Estonian: Kõrge vererõhu ja teist tüüpi diabeediga kaasuva neeruhaigusega patsiendid Kõrge vererõhu ja teist tüüpi diabeediga patsientidel on kaasuva neeruhaiguse raviks soovitatav säilitusannus 300 mg üks kord päevas.
English: Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg (two tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.
Estonian: Kõrge vererõhu ja teist tüüpi diabeediga kaasuva neeruhaigusega patsiendid Kõrge vererõhu ja teist tüüpi diabeediga patsientidel on kaasuva neeruhaiguse raviks soovitatav säilitusannus 300 mg (kaks tabletti päevas) üks kord päevas.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg of irbesartan.
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Üks õhukese polümeerikilega kaetud tablett sisaldab 150 mg irbesartaani.
English: Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.
Estonian: Kõrge vererõhu ja teist tüüpi diabeediga kaasuva neeruhaigusega patsiendid Kõrge vererõhu ja teist tüüpi diabeediga patsientidel on kaasuva neeruhaiguse raviks soovitatav säilitusannus 300 mg (neli tabletti päevas) üks kord päevas.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300 mg of irbesartan.
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Üks õhukese polümeerikilega kaetud tablett sisaldab 300 mg irbesartaani.
English: Irbesartan BMS 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Estonian: Irbesartan BMS 75 mg tablette väljastatakse blisterpakendites 14, 28, 56 või 98 kaupa.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 300 mg tablets.
Estonian: RAVIMPREPARAADI NIMETUS Irbesartan BMS 300 mg tabletid.
English: Arthralgia, myalgia (in some cases associated with increased plasma creatine kinase levels), muscle cramps
Estonian: Lihas-skeleti, sidekoe ja luude kahjustused: Artralgia, müalgia (mõnel juhul on kaasnenud kreatiinkinaasi taseme tõus plasmas), lihaskrambid
English: Irbesartan BMS 150 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Estonian: Irbesartan BMS 150 mg tablette väljastatakse blisterpakendites 14, 28, 56 või 98 kaupa.
English: Irbesartan BMS 300 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Estonian: Irbesartan BMS 300 mg tablette väljastatakse blisterpakendites 14, 28, 56 või 98 kaupa.
English: Cartons of 84 film-coated tablets: 6 blister cards of 14 film-coated tablets in PVC/PVDC/Aluminium blisters.
Estonian: Karbis on 84 õhukese polümeerikihiga kaetud tabletti: 6 blistririba 14 õhukese polümeerikihiga kaetud tabletiga PVC/PVDC/alumiinium blistris.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 75 mg film-coated tablets irbesartan
Estonian: RAVIMPREPARAADI NIMETUS Irbesartan BMS 75 mg õhukese polümeerikilega kaetud tabletid irbesartaan
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains: irbesartan 300 mg
Estonian: TOIMEAINE(TE) SISALDUS Tablett sisaldab 300 mg irbesartaani
English: PACKAGE LEAFLET: INFORMATION FOR THE USER Irbesartan BMS 75 mg film-coated tablets irbesartan
Estonian: PAKENDI INFOLEHT: INFORMATSIOON KASUTAJALE Irbesartan BMS 75 mg õhukese polümeerikilega kaetud tabletid irbesartaan
English: A.
Estonian: L
English: EU/1/06/375/011 - 14 tablets EU/1/06/375/012 - 28 tablets EU/1/06/375/013 - 56 tablets EU/1/06/375/014 - 56 x 1 tablets EU/1/06/375/015 - 98 tablets
Estonian: EU/1/06/375/011 - 14 tabletti EU/1/06/375/012 - 28 tabletti EU/1/06/375/013 - 56 tabletti EU/1/06/375/014 - 56 x 1 tabletti EU/1/06/375/015 - 98 tabletti
English: Irbesartan BMS 300 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 filmcoated tablets.
Estonian: Irbesartan BMS 300 mg õhukese polümeerikilega kaetud tablette väljastatakse blisterpakendites 14, 28, 56, 84 või 98 kaupa.
English: Irbesartan BMS 150 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 filmcoated tablets.
Estonian: Irbesartan BMS 150 mg õhukese polümeerikilega kaetud tablette väljastatakse blisterpakendites 14, 28, 56, 84 või 98 kaupa.
English: Irbesartan BMS 75 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 filmcoated tablets.
Estonian: Irbesartan BMS 75 mg õhukese polümeerikilega kaetud tablette väljastatakse blisterpakendites 14, 28, 56, 84 või 98 kaupa.
English: What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 75 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.
Estonian: Kuidas Irbesartan BMS välja näeb ja pakendi sisu Irbesartan BMS 75 mg tabletid on valged või valkjad, kaksikkumerad ja ovaalse kujuga, mille ühele küljele on sisse pressitud südame kujutis ja teisele küljele on graveeritud number 2771.
English: Sat
Estonian: köha
English: EU/1/06/375/016 - 14 tablets EU/1/06/375/017 - 28 tablets EU/1/06/375/018 - 56 tablets EU/1/06/375/019 - 56 x 1 tablets EU/1/06/375/020 - 84 tablets EU/1/06/375/021 - 98 tablets
Estonian: EU/1/06/375/016 - 14 tabletti EU/1/06/375/017 - 28 tabletti EU/1/06/375/018 - 56 tabletti EU/1/06/375/019 - 56 x 1 tabletti EU/1/06/375/020 - 84 tabletti EU/1/06/375/021 - 98 tabletti
English: Vascular disorders: Common:
Estonian: lihasskeleti valu* Vaskulaarsed häired: Sage:
English: EU/1/06/375/022 - 14 tablets EU/1/06/375/023 - 28 tablets EU/1/06/375/024 - 56 tablets EU/1/06/375/025 - 56 x 1 tablets EU/1/06/375/026 - 84 tablets EU/1/06/375/027 - 98 tablets
Estonian: EU/1/06/375/022 - 14 tabletti EU/1/06/375/023 - 28 tabletti EU/1/06/375/024 - 56 tabletti EU/1/06/375/025 - 56 x 1 tabletti EU/1/06/375/026 - 84 tabletti EU/1/06/375/027 - 98 tabletti
English: NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 150 mg film-coated tablets irbesartan
Estonian: RAVIMPREPARAADI NIMETUS Irbesartan BMS 150 mg õhukese polümeerikilega kaetud tabletid irbesartaan
English: NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 300 mg film-coated tablets irbesartan
Estonian: RAVIMPREPARAADI NIMETUS Irbesartan BMS 300 mg õhukese polümeerikilega kaetud tabletid irbesartaan
English: What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 75 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2871 engraved on the other side.
Estonian: Kuidas Irbesartan BMS välja näeb ja pakendi sisu Irbesartan BMS 75 mg õhukese polümeerikilega kaetud tabletid on valged või valkjad, kaksikkumerad ja ovaalse kujuga, mille ühele küljele on sisse pressitud südame kujutis ja teisele küljele on graveeritud number 2871.
English: EU/1/06/375/006 - 14 tablets EU/1/06/375/007 - 28 tablets EU/1/06/375/008 - 56 tablets EU/1/06/375/009 - 56 x 1 tablets EU/1/06/375/010 - 98 tablets
Estonian: EU/1/06/375/006 - 14 tabletti EU/1/06/375/007 - 28 tabletti EU/1/06/375/008 - 56 tabletti EU/1/06/375/009 - 56 x 1 tabletti EU/1/06/375/010 - 98 tabletti
English: What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 300 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2773 engraved on the other side.
Estonian: Kuidas Irbesartan BMS välja näeb ja pakendi sisu Irbesartan BMS 300 mg tabletid on valged või valkjad, kaksikkumerad ja ovaalse kujuga, mille ühele küljele on sisse pressitud südame kujutis ja teisele küljele on graveeritud number 2773.
English: Investigations:
Estonian: Uuringud: Väga sage:
English: Cartons of 56 film-coated tablets: 4 blister cards of 14 film-coated tablets in PVC/PVDC/Aluminium blisters.
Estonian: Karbis on 56 õhukese polümeerikihiga kaetud tabletti: 4 blistririba 14 õhukese polümeerikihiga kaetud tabletiga PVC/PVDC/alumiinium blistris.
English: EU/1/06/375/028 - 14 tablets EU/1/06/375/029 - 28 tablets EU/1/06/375/030 - 56 tablets EU/1/06/375/031 - 56 x 1 tablets EU/1/06/375/032 - 84 tablets EU/1/06/375/033 - 98 tablets
Estonian: EU/1/06/375/028 - 14 tabletti EU/1/06/375/029 - 28 tabletti EU/1/06/375/030 - 56 tabletti EU/1/06/375/031 - 56 x 1 tabletti EU/1/06/375/032 - 84 tabletti EU/1/06/375/033 - 98 tabletti
English: Cartons of 28 film-coated tablets: 2 blister cards of 14 film-coated tablets in PVC/PVDC/Aluminium blisters.
Estonian: Karbis on 28 õhukese polümeerikihiga kaetud tabletti: 2 blistririba 14 õhukese polümeerikihiga kaetud tabletiga PVC/PVDC/alumiinium blistris.
English: EU/1/06/375/001 - 14 tablets EU/1/06/375/002 - 28 tablets EU/1/06/375/003 - 56 tablets EU/1/06/375/004 - 56 x 1 tablets EU/1/06/375/005 - 98 tablets
Estonian: EU/1/06/375/001 - 14 tabletti EU/1/06/375/002 - 28 tabletti EU/1/06/375/003 - 56 tabletti EU/1/06/375/004 - 56 x 1 tabletti EU/1/06/375/005 - 98 tabletti
English: Musculoskeletal and connective tissue disorders: Common:
Estonian: kõhulahtisus, düspepsia/kõrvetised Lihas-skeleti, ja sidekoe kahjustused: Sage:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains: irbesartan 75 mg
Estonian: TOIMEAINE(TE) SISALDUS Tablett sisaldab 75 mg irbesartaani
English: PACKAGE LEAFLET: INFORMATION FOR THE USER Irbesartan BMS 150 mg film-coated tablets irbesartan
Estonian: PAKENDI INFOLEHT: INFORMATSIOON KASUTAJALE Irbesartan BMS 150 mg õhukese polümeerikilega kaetud tabletid irbesartaan
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
Estonian: MÜÜGILOA HOIDJALE ESITATUD HANKE- JA KASUTUSTINGIMUSED JA
English: What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 150 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2772 engraved on the other side.
Estonian: Kuidas Irbesartan BMS välja näeb ja pakendi sisu Irbesartan BMS 150 mg tabletid on valged või valkjad, kaksikkumerad ja ovaalse kujuga, mille ühele küljele on sisse pressitud südame kujutis ja teisele küljele on graveeritud number 2772.
English: PACKAGE LEAFLET: INFORMATION FOR THE USER Irbesartan BMS 300 mg film-coated tablets irbesartan
Estonian: PAKENDI INFOLEHT: INFORMATSIOON KASUTAJALE Irbesartan BMS 300 mg õhukese polümeerikilega kaetud tabletid irbesartaan
English: Uncommon: chest pain
Estonian: valu rindkeres
English: What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 300 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2873 engraved on the other side.
Estonian: Kuidas Irbesartan BMS välja näeb ja pakendi sisu Irbesartan BMS 300 mg õhukese polümeerikilega kaetud tabletid on valged või valkjad, kaksikkumerad ja ovaalse kujuga, mille ühele küljele on sisse pressitud südame kujutis ja teisele küljele on graveeritud number 2873.
English: Cartons of 98 film-coated tablets: 7 blister cards of 14 film-coated tablets in PVC/PVDC/Aluminium blisters.
Estonian: Karbis on 98 õhukese polümeerikihiga kaetud tabletti: 7 blistririba 14 õhukese polümeerikihiga kaetud tabletiga PVC/PVDC/alumiinium blistris.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains: irbesartan 150 mg
Estonian: TOIMEAINE(TE) SISALDUS Tablett sisaldab 150 mg irbesartaani
English: Cartons of 14 film-coated tablets: 1 blister card of 14 film-coated tablets in PVC/PVDC/Aluminium blisters.
Estonian: Karbis on 14 õhukese polümeerikihiga kaetud tabletti: 1 blistririba 14 õhukese polümeerikihiga kaetud tabletiga PVC/PVDC/alumiinium blistris.
English: What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 150 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2872 engraved on the other side.
Estonian: Kuidas Irbesartan BMS välja näeb ja pakendi sisu Irbesartan BMS 150 mg õhukese polümeerikilega kaetud tabletid on valged või valkjad, kaksikkumerad ja ovaalse kujuga, mille ühele küljele on sisse pressitud südame kujutis ja teisele küljele on graveeritud number 2872.
English: Respiratory, thoracic and mediastinal disorders: Uncommon: cough
Estonian: pearinglus, ortostaatiline pearinglus* Respiratoorsed, rindkere ja mediastiinumi häired: Aeg-ajalt:
English: The PSUR cycle of Irbesartan BMS is aligned with the cross-referred product, KARVEA, until otherwise specified.
Estonian: Kuni pole osutatud teisiti, kattub Irbesartan BMS'i perioodiliste ohutusaruannete (PSUR) tsükkel viidatud ravimite KARVEA tsükliga.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 75 mg film-coated tablets.
Estonian: RAVIMPREPARAADI NIMETUS Irbesartan BMS 75 mg õhukese polümeerikilega kaetud tabletid.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 150 mg film-coated tablets.
Estonian: RAVIMPREPARAADI NIMETUS Irbesartan BMS 150 mg õhukese polümeerikilega kaetud tabletid.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 300 mg film-coated tablets.
Estonian: RAVIMPREPARAADI NIMETUS Irbesartan BMS 300 mg õhukese polümeerikilega kaetud tabletid.
English: Strength Pharmaceutical Form Route of Administration Immediate Packaging
Estonian: Tugevus Ravimvorm
English: Protection starts from 25 days after the last injection and lasts for at least a year.
Estonian: Kaitse haiguse vastu tekib 25 päeva pärast viimast süsti ning püsib vähemalt 1 aasta.
English: After the second injection, animals may show a slight, temporary increase in body temperature of 0.4 ºC, in the 24 hours after vaccination.
Estonian: Loomadel võib 24 tunni jooksul pärast teist süsti ajutiselt tõusta kehatemperatuur 0,4 ºC võrra.
English: The first injection is given from three months of age and the second injection is given three weeks later.
Estonian: Esimene süst tehakse 3 kuu vanustele loomadele ja teine 3 nädalat hiljem.
English: The European Commission granted a marketing authorisation valid throughout the EU for ZULVAC 8 Bovis on 15 January 2010.
Estonian: Euroopa Komisjon andis vaktsiini ZULVAC 8 Bovis müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 15. jaanuaril 2010.
English: The efficacy of the vaccine in cattle was studied in a laboratory trial using the vaccine in calves from two and a half months of age.
Estonian: Vaktsiini efektiivsust veistel uuriti laborikatses, milles kasutati vaktsiini vähemalt 2,5 kuu vanustel noorloomadel.
English: Results from a series of laboratory safety trials performed with a vaccine of similar composition containing serotypes 1 and 8 and of studies performed with a vaccine of the same composition but of different serotype, used in sheep were presented in order to extrapolate safety conclusions.
Estonian: Ohutustulemuste ekstrapoleerimiseks esitati mitme laboratoorse ohutuskatse tulemused sarnase koostisega vaktsiini kohta, mis sisaldas serotüüpe 1 ja 8, ning selliste uuringute tulemused, mis viidi läbi sama koostise, kuid erineva serotüübiga vaktsiiniga, mida kasutati lammastel.
English: The studies showed that the vaccine is safe for cattle and that it prevents viraemia in animals from three months of age that are infected with bluetongue virus serotype 8.
Estonian: Uuringud näitasid, et vaktsiin on veistele ohutu ning ennetab vireemiat vähemalt 3 kuu vanustel veistel, kes on nakatunud lammaste katarraalse palaviku viiruse 8. serotüübiga.
English: The vaccine is used to prevent viraemia (the presence of the virus in the blood) in cattle from three months of age.
Estonian: Vaktsiini kasutatakse vireemia (viiruse esinemine veres) ennetamiseks vähemalt 3 kuu vanustel veistel.
English: In 2013 the CVMP considered that the submitted data were adequate for the authorisation of ZULVAC 8 Bovis to convert to a normal status.
Estonian: 2013. aastal leidis veterinaarravimite komitee, et esitatud andmed on piisavad, et muuta ZULVAC 8 Bovis müügiluba tavakorras väljastatuks.
English: The vaccine is given to animals as an injection in the muscle.
Estonian: Vaktsiini manustatakse noorloomadele süstena lihasesse.
English: This means that it was not possible to obtain complete information about ZULVAC 8 Bovis at the time of the initial authorisation.
Estonian: See tähendab, et vaktsiini ZULVAC 8 Bovis kohta ei ole olnud esmase müügiloa andmisel võimalik saada täielikku teavet.
English: It contains inactivated (killed) bluetongue serotype 8 virus.
Estonian: See sisaldab lammaste katarraalse palaviku inaktiveeritud (hävitatud) viiruse 8. serotüüpi.
English: In the future, if the animals are exposed to the bluetongue virus the immune system will be able to produce antibodies more quickly.
Estonian: hiljem lammaste katarraalse palaviku viirusega uuesti kokku, tekivad antikehad kiiremini.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of ZULVAC 8 Bovis exceed the risks in the prevention of viraemia caused by the bluetongue virus serotype 8 in cattle from three months of age.
Estonian: Veterinaarravimite komitee järeldas, et vaktsiini ZULVAC 8 Bovis kasulikkus on suurem kui sellega kaasnevad riskid lammaste katarraalse palaviku viiruse 8. serotüübist põhjustatud vireemia ennetamisel vähemalt 3 kuu vanustel veistel.
English: ZULVAC 8 Bovis contains bluetongue viruses that have been inactivated so that they cannot cause the disease.
Estonian: ZULVAC 8 Bovis sisaldab lammaste katarraalse palaviku viirust, mis on inaktiveeritud ega suuda seetõttu haigust tekitada.
English: ZULVAC 8 Bovis contains bluetongue virus of one type (serotype 8).
Estonian: ZULVAC 8 Bovis sisaldab lammaste katarraalse palaviku viiruse teatud vormi (8. serotüüpi).
English: The withdrawal period for ZULVAC 8 Bovis for meat and milk is zero days.
Estonian: Vaktsiini ZULVAC 8 Bovis keeluaeg liha ja piima korral on 0 päeva.
English: ZULVAC 8 Bovis is a vaccine.
Estonian: ZULVAC 8 Bovis on vaktsiin.
English: What is ZULVAC 8 Bovis?
Estonian: Mis on ZULVAC 8 Bovis?
English: The safety of the vaccine was studied in laboratory safety studies carried out with ZULVAC 8 Bovis in cattle.
Estonian: Vaktsiini ZULVAC 8 Bovis ohutust uuriti veiste laboratoorsetes ohutusuuringutes.
English: Another laboratory study looked at the duration of the immunity following vaccination with ZULVAC 8 Bovis.
Estonian: Ühes laboriuuringus vaadeldi ZULVAC 8 Bovisega vaktsineerimise järel tekkinud immuunsuse kestust.
English: Why has ZULVAC 8 Bovis been approved?
Estonian: Miks vaktsiin ZULVAC 8 Bovis heaks kiideti?
English: Inactivated vaccine against Bluetongue virus, serotype 8
Estonian: Lammaste katarraalse palaviku viiruse 8. serotüübi vaktsiin (inaktiveeritud)
English: ZULVAC 8 Bovis was initially authorised under ‘exceptional circumstances'.
Estonian: Vaktsiinile ZULVAC 8 Bovis anti müügiluba algselt erandkorras.
English: ZULVAC 8 Bovis is a vaccine that is available as a suspension for injection.
Estonian: ZULVAC 8 Bovis on vaktsiin, mida turustatakse süstesuspensioonina.
English: Other information about ZULVAC 8 Bovis:
Estonian: Muu teave vaktsiini ZULVAC 8 Bovis kohta
English: What is the risk associated with ZULVAC 8 Bovis?
Estonian: Mis riskid vaktsiiniga ZULVAC 8 Bovis kaasnevad?
English: How has ZULVAC 8 Bovis been studied?
Estonian: Kuidas vaktsiini ZULVAC 8 Bovis uuriti?
English: How does ZULVAC 8 Bovis work?
Estonian: Kuidas vaktsiin ZULVAC 8 Bovis toimib?
English: ZULVAC 8 Bovis is used in cattle to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges.
Estonian: Vaktsiini ZULVAC 8 Bovis kasutatakse veiste kaitsmiseks lammaste katarraalse palaviku eest.
English: What is ZULVAC 8 Bovis used for?
Estonian: Milleks vaktsiini ZULVAC 8 Bovis kasutatakse?
English: What benefit has ZULVAC 8 Bovis shown during the studies?
Estonian: Milles seisneb uuringute põhjal vaktsiini ZULVAC 8 Bovis kasulikkus?
English: This will help prevent dehydration.
Estonian: See aitab vältida dehüdratsiooni.
English: Elderly (≥ 65 years)
Estonian: Eakad (≥ 65 aasta)
English: Frequency cannot be estimated from available data.
Estonian: Esinemissagedust ei saa hinnata olemasolevate andmete alusel.
English: ** Based on post-marketing reports.
Estonian: ** Tugineb turustamisjärgsetel teadetel.
English: - The unopened bottle does not require any special storage conditions.
Estonian: - Avamata pudelid ei vaja säilitamisel eritingimusi.
English: Italia Teva Italia S.r.l.
Estonian: Teva Italia S.r.l.
English: This is especially important for the elderly (≥ 65 years) and for patients receiving diuretic therapy.
Estonian: See on eriti oluline eakate (≥ 65 aasta) ja diureetilist ravi saavate patsientide puhul.
English: Date of first authorisation: 16 August 2012 Date of latest renewal:
Estonian: Müügiloa esmase väljastamise kuupäev: 16. august 2012 Müügiloa viimase uuendamise kuupäev:
English: Table 2 Summary of vertebral fracture efficacy at 12, 24 and 36 months Outcome
Estonian: Tabel 2 Kokkuvõte toimest lülimurdudele 12, 24 ja 36 kuu möödudes
English: Zoledronic acid was administered once a year, until at least 211 patients in the study population had confirmed clinical fractures.
Estonian: Zoledroonhapet manustati üks kord aastas kuni vähemalt 211-l uuringus osalejal oli tekkinud kinnitatud kliiniline luumurd.
English: • Contraindication in pregnancy and in breast-feeding women due to potential teratogenicity
Estonian: • Vastunäidustus raseduse ja rinnaga toitmise suhtes potentsiaalse teratogeensuse tõttu
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 August 2012
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE/MÜÜGILOA UUENDAMISE KUUPÄEV Müügiloa esmase väljastamise kuupäev: 16. august 2012
English: It is important to take calcium and vitamin D supplements (for example tablets) as directed by your doctor.
Estonian: Oluline on kasutada kaltsiumi ja D vitamiini preparaate (näiteks tablette) vastavalt arsti soovitustele.