FrancophonIA/ELRC3.0 huggingface dataset:
English: o Each Segluromet 2.5 mg/1,000 mg film-coated tablet contains 2.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 1,000 mg of metformin hydrochloride.
Estonian: o Üks Segluromet 2,5 mg/1000 mg õhukese polümeerikattega tablett sisaldab 2,5 mg ertugliflosiini (ertugliflosiin-L-püroglutaamhappega) ja 1000 mg metformiinvesinikkloriidi.
English: Segluromet 2.5 mg/850 mg tablets ertugliflozin/metformin hydrochloride
Estonian: Segluromet 2,5 mg/850 mg tabletid ertugliflozinum/metformini hydrochloridum
English: o Each Segluromet 7.5 mg/1,000 mg film-coated tablet contains 7.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 1,000 mg of metformin hydrochloride.
Estonian: o Üks Segluromet 7,5 mg/1000 mg õhukese polümeerikattega tablett sisaldab 7,5 mg ertugliflosiini (ertugliflosiin-L-püroglutaamhappega) ja 1000 mg metformiinvesinikkloriidi.
English: Segluromet 7.5 mg/850 mg tablets ertugliflozin/metformin hydrochloride
Estonian: Segluromet 7,5 mg/850 mg tabletid ertugliflozinum/metformini hydrochloridum
English: Each tablet contains 2.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 850 mg of metformin hydrochloride.
Estonian: Üks tablett sisaldab 2,5 mg ertugliflosiini (ertugliflosiin-L-püroglutaamhappega) ja 850 mg metformiinvesinikkloriidi.
English: Segluromet 7.5 mg/1000 mg tablets ertugliflozin/metformin hydrochloride
Estonian: Segluromet 7,5 mg/1000 mg tabletid ertugliflozinum/metformini hydrochloridum
English: Segluromet 2.5 mg/1000 mg tablets ertugliflozin/metformin hydrochloride
Estonian: Segluromet 2,5 mg/1000 mg tabletid ertugliflozinum/metformini hydrochloridum
English: Each tablet contains 7.5 mg of ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 850 mg of metformin hydrochloride.
Estonian: Üks tablett sisaldab 7,5 mg ertugliflosiini (ertugliflosiin-L-püroglutaamhappega) ja 850 mg metformiinvesinikkloriidi.
English: Segluromet 2.5 mg/1,000 mg film-coated tablets and Segluromet 7.5 mg/1,000 mg film-coated tablets Hypromellose (E464)
Estonian: Segluromet 2,5 mg/1000 mg õhukese polümeerikattega tabletid ja Segluromet 7,5 mg/1000 mg õhukese polümeerikattega tabletid
English: Segluromet 2.5 mg/1,000 mg film-coated tablets Each tablet contains 2.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 1,000 mg of metformin hydrochloride.
Estonian: Segluromet 2,5 mg/1000 mg õhukese polümeerikattega tabletid Üks tablett sisaldab 2,5 mg ertugliflosiini (ertugliflosiin-L-püroglutaamhappega) ja 1000 mg metformiinvesinikkloriidi.
English: Urine glucose
Estonian: Glükoos uriinis
English: Segluromet 7.5 mg/1,000 mg film-coated tablets Each tablet contains 7.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 1,000 mg metformin hydrochloride.
Estonian: Segluromet 7,5 mg/1000 mg õhukese polümeerikattega tabletid Üks tablett sisaldab 7,5 mg ertugliflosiini (ertugliflosiin-L-püroglutaamhappega) ja 1000 mg metformiinvesinikkloriidi.
English: Multipack: 196 (4 packs of 49) film-coated tablets
Estonian: 168 õhukese polümeerikattega tabletti 180 õhukese polümeerikattega tabletti Mitmikpakend: 196 (4 pakendit, igas 49) õhukese polümeerikattega tabletti
English: Segluromet 2.5 mg/850 mg film-coated tablets and Segluromet 7.5 mg/850 mg film-coated tablets Hypromellose (E464)
Estonian: Segluromet 2,5 mg/850 mg õhukese polümeerikattega tabletid ja Segluromet 7,5 mg/850 mg õhukese polümeerikattega tabletid
English: Volume depletion*
Estonian: Laktatsidoos*
English: • stomach ache (abdominal pain)
Estonian: • maovalu (kõhuvalu),
English: Difference from Sitagliptin (LS mean
Estonian: Erinevus võrreldes sitagliptiiniga (vähimruutude keskmine
English: EU/1/18/1265/022 (14 film-coated tablets) EU/1/18/1265/023 (28 film-coated tablets) EU/1/18/1265/024 (30x1 film-coated tablets) EU/1/18/1265/025 (56 film-coated tablets) EU/1/18/1265/026 (60 film-coated tablets) EU/1/18/1265/027 (168 film-coated tablets) EU/1/18/1265/028 (180 film-coated tablets) EU/1/18/1265/032 (196 (4 x 49) film-coated tablets)
Estonian: EU/1/18/1265/022 (14 õhukese polümeerikattega tabletti) EU/1/18/1265/023 (28 õhukese polümeerikattega tabletti) EU/1/18/1265/024 (30x1 õhukese polümeerikattega tabletti) EU/1/18/1265/025 (56 õhukese polümeerikattega tabletti) EU/1/18/1265/026 (60 õhukese polümeerikattega tabletti) EU/1/18/1265/027 (168 õhukese polümeerikattega tabletti) EU/1/18/1265/028 (180 õhukese polümeerikattega tabletti) EU/1/18/1265/032 (196 (4 x 49) õhukese polümeerikattega tabletti)
English: EU/1/18/1265/008 (14 film-coated tablets) EU/1/18/1265/009 (28 film-coated tablets) EU/1/18/1265/010 (30x1 film-coated tablets) EU/1/18/1265/011 (56 film-coated tablets) EU/1/18/1265/012 (60 film-coated tablets) EU/1/18/1265/013 (168 film-coated tablets) EU/1/18/1265/014 (180 film-coated tablets) EU/1/18/1265/030 (196 (4 x 49) film-coated tablets)
Estonian: EU/1/18/1265/008 (14 õhukese polümeerikattega tabletti) EU/1/18/1265/009 (28 õhukese polümeerikattega tabletti) EU/1/18/1265/010 (30x1 õhukese polümeerikattega tabletti) EU/1/18/1265/011 (56 õhukese polümeerikattega tabletti) EU/1/18/1265/012 (60 õhukese polümeerikattega tabletti) EU/1/18/1265/013 (168 õhukese polümeerikattega tabletti) EU/1/18/1265/014 (180 õhukese polümeerikattega tabletti) EU/1/18/1265/030 (196 (4 x 49) õhukese polümeerikattega tabletti)
English: EU/1/18/1265/001 (14 film-coated tablets) EU/1/18/1265/002 (28 film-coated tablets) EU/1/18/1265/003 (30x1 film-coated tablets) EU/1/18/1265/004 (56 film-coated tablets) EU/1/18/1265/005 (60 film-coated tablets) EU/1/18/1265/006 (168 film-coated tablets) EU/1/18/1265/007 (180 film-coated tablets) EU/1/18/1265/029 (196 (4 x 49) film-coated tablets)
Estonian: EU/1/18/1265/001 (14 õhukese polümeerikattega tabletti) EU/1/18/1265/002 (28 õhukese polümeerikattega tabletti) EU/1/18/1265/003 (30x1 õhukese polümeerikattega tabletti) EU/1/18/1265/004 (56 õhukese polümeerikattega tabletti) EU/1/18/1265/005 (60 õhukese polümeerikattega tabletti) EU/1/18/1265/006 (168 õhukese polümeerikattega tabletti) EU/1/18/1265/007 (180 õhukese polümeerikattega tabletti) EU/1/18/1265/029 (196 (4 x 49) õhukese polümeerikattega tabletti)
English: Volume depletion (ertugliflozin)
Estonian: Ringleva veremahu vähenemine (ertugliflosiin)
English: Table 4: Results at Week 26 from an add-on study of ertugliflozin in combination with metformin and sitagliptin*
Estonian: 26. nädala tulemused metformiini ja sitagliptiini kombinatsioonile ertugliflosiini lisamise uuringust*
English: EU/1/18/1265/015 (14 film-coated tablets) EU/1/18/1265/016 (28 film-coated tablets) EU/1/18/1265/017 (30x1 film-coated tablets) EU/1/18/1265/018 (56 film-coated tablets) EU/1/18/1265/019 (60 film-coated tablets) EU/1/18/1265/020 (168 film-coated tablets) EU/1/18/1265/021 (180 film-coated tablets) EU/1/18/1265/031 (196 (4 x 49) film-coated tablets)
Estonian: EU/1/18/1265/015 (14 õhukese polümeerikattega tabletti) EU/1/18/1265/016 (28 õhukese polümeerikattega tabletti) EU/1/18/1265/017 (30x1 õhukese polümeerikattega tabletti) EU/1/18/1265/018 (56 õhukese polümeerikattega tabletti) EU/1/18/1265/019 (60 õhukese polümeerikattega tabletti) EU/1/18/1265/020 (168 õhukese polümeerikattega tabletti) EU/1/18/1265/021 (180 õhukese polümeerikattega tabletti) EU/1/18/1265/031 (196 (4 x 49) õhukese polümeerikattega tabletti)
English: There was, however, an increased incidence of benign stromal uterine polyps in female rats treated with 900 mg/kg/day.
Estonian: Emastel rottidel, kes said ravimit annuses 900 mg/kg ööpäevas, leiti siiski suurema esinemissagedusega emaka strooma healoomulisi polüüpe.
English: Change from baseline (LS mean Difference from glimepiride (LS mean
Estonian: Erinevus võrreldes glimepiriidiga (vähimruutude keskmine
English: A total of 1,326 patients with type 2 diabetes inadequately controlled on metformin monotherapy participated in a randomised, double-blind, multi-centre, 52-week, active comparator-controlled study to evaluate the efficacy and safety of ertugliflozin in combination with metformin.
Estonian: Aktiivkontrolliga uuring ertugliflosiini või glimepiriidi lisamise kohta metformiinile Ühes randomiseeritud topeltpimedas mitmekeskuselises 52-nädalases aktiivse võrdlusravimiga kontrollitud uuringus, milles hinnati ertugliflosiini ohutust ja efektiivsust kombinatsioonis metformiiniga, osales kokku 1326 patsienti, kellel oli 2. tüüpi diabeet, mis ei allunud piisavalt metformiini monoteraapiale.
English: Adverse reaction with ertugliflozin.
Estonian: Ertugliflosiini kõrvaltoime
English: Segluromet 2.5 mg/850 mg film-coated tablets
Estonian: SEGLUROMET 2,5 mg/850 mg VÄLISKARP
English: Segluromet 7.5 mg/850 mg film-coated tablets
Estonian: SEGLUROMET 7,5 mg/850 mg VÄLISKARP
English: • if you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis.
Estonian: iivelduse, oksendamise, kõhulahtisuse, kiire kehakaalu languse, laktatsidoosiga (vt allpool
English: OUTER CARTON FOR SEGLUROMET 7.5 mg/1000 mg
Estonian: SEGLUROMET 7,5 mg/1000 mg VÄLISKARP
English: OUTER CARTON FOR SEGLUROMET 2.5 mg/1000 mg
Estonian: SEGLUROMET 2,5 mg/1000 mg VÄLISKARP
English: Epivir lamivudine
Estonian: Epivir lamivudiin
English: A risk management plan has been developed to ensure that Epivir is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Epiviri võimalikult ohutu kasutamine.
English: What measures are being taken to ensure the safe and effective use of Epivir?
Estonian: Mis meetmed võetakse, et tagada Epiviri ohutu ja efektiivne kasutamine?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Epivir on 8 August 1996.
Estonian: Euroopa Komisjon andis Epiviri müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 8. augustil
English: The full EPAR for Epivir can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Epiviri kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The combination also reduced viral loads in all studies after two to four weeks of treatment, but this effect was temporary.
Estonian: See kombinatsioon vähendas ka kõikides uuringutes pärast 2-4-nädalast ravi viiruskoormust, kuid see toime oli ajutine.
English: Similar results were seen in HIV-infected patients aged under 15 years.
Estonian: Sarnased tulemused esinesid ka HIV-nakkusega alla 15-aastastel patsientidel.
English: It does not cure HIV infection or AIDS, but it can hold off damage to the immune system and avoid the development of infections and diseases associated with AIDS.
Estonian: See ei ravi HIV-nakkust ega AIDS-i välja, kuid võib immuunsüsteemi kahjustumist ning AIDS-iga seotud nakkuste ja haiguste tekkimist edasi lükata.
English: Epivir has also been studied in 615 patients aged between nine months and 15 years.
Estonian: Epiviri uuriti ka 615 patsiendil vanuses 9 kuust 15 aastani.
English: It is available as tablets (150 and 300 mg) and as an oral solution (10 mg/ml).
Estonian: Seda turustatakse tablettidena (300 mg) ja suukaudse lahusena (10 mg/ml).
English: This study looked at how many patients had developed an illness associated with AIDS or had died after a year's treatment.
Estonian: Selles uuringus vaadeldi, mitu patsienti oli pärast üheaastast ravi haigestunud AIDSiga seotud haigusesse või surnud.
English: Other information about Epivir
Estonian: Muu teave Epiviri kohta
English: The CHMP decided that Epivir's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Epiviri kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: In the fifth adult study, adding Epivir to existing treatment reduced the risk of disease progression or death: after a year, 9% of the patients taking Epivir had developed an AIDS-related illness or died (128 out of 1,369), compared with 20% of those taking placebo (95 out of 471).
Estonian: Viiendas täiskasvanute uuringus vähendas Epiviri lisamine olemasolevale ravile haiguse progresseerumise või surma riski: pärast üht aastat oli patsiente, kes haigestusid AIDSiga seotud haigusesse või surid, Epiviri uuringurühmas 9% (128 patsienti 1369st) ja platseeborühmas 20% (95 patsienti 471st).
English: Epivir is a medicine containing the active substance lamivudine.
Estonian: Epivir on ravim, mis sisaldab toimeainena lamivudiini.
English: The most common side effects with Epivir (seen in between 1 and 10 patients in 100) are diarrhoea, nausea (feeling sick), vomiting, headache, insomnia (difficulty sleeping), cough, nasal symptoms, rash, muscle disorders, arthralgia (joint pain), alopecia (hair loss), fever, abdominal pain (stomach ache) or cramps, malaise (feeling unwell) and fatigue (tiredness).
Estonian: Epiviri kõige sagedamad kõrvalnähud (esinenud 1-10 patsiendil 100st) on kõhulahtisus, iiveldus, oksendamine, peavalu, unetus, köha, ninasümptomid, lööve, lihasehäired, liigesevalu, alopeetsia (juuste väljalangemine), palavik, kõhuvalu või -krambid, halb enesetunne ja väsimus.
English: All of the studies found that combinations including Epivir were more effective than the comparator medicines.
Estonian: Kõikides uuringutes leiti, et Epiviri sisaldavad kombinatsioonid olid võrdlusravimitest efektiivsemad.
English: This can be taken either as a single daily dose or divided into 150 mg twice a day.
Estonian: Ööpäevase annuse tohib võtta ühekorraga või jagatuna kaks korda ööpäevas võetavaks 150 mg annuseks.
English: Patients who cannot swallow tablets should use the oral solution, or alternatively they may crush the tablets and add them to a small amount of food or drink immediately before swallowing it.
Estonian: Kui patsiendid ei suuda tablette neelata, tuleb kasutada suukaudset lahust või lisada purustatud tabletid vahetult enne annuse võtmist väikesele söögi- või joogikogusele.
English: CD4 T-cells are white blood cells that are important in helping to fight infections, but which are killed by HIV.
Estonian: CD4-T-rakud on leukotsüüdid (vere valgelibled), mis aitavad oluliselt nakkuste vastu võidelda, kuid mida HIV hävitab.
English: This document is a summary of the European Public Assessment Report (EPAR) for Epivir.
Estonian: Käesolev dokument on ravimi Epivir Euroopa avaliku hindamisaruande kokkuvõte.
English: Epivir has been studied in five main studies involving almost 3,000 adults (aged 18 years or over).
Estonian: Epiviri uuriti viies põhiuuringus, milles osales ligi 3000 täiskasvanud (vähemalt 18-aastast) patsienti.
English: The recommended dose of Epivir for adults and children weighing at least 25 kg is 300 mg a day.
Estonian: Epiviri soovitatav annus täiskasvanutele ja vähemalt 25 kg kehamassiga lastele on 600 mg ööpäevas.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Epivir, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Epiviri omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: What is Epivir?
Estonian: Mis on Epivir?
English: Epivir, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Estonian: Koos teiste viiruseravimitega võetav Epivir vähendab HIV-sisaldust veres ja hoiab selle sisalduse väikese.
English: For more information about treatment with Epivir, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Epiviriga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Epivir.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: The fifth study compared the effects of adding Epivir or placebo (a dummy treatment) to existing treatment for HIV infection in 1,895 adults who had been taking antiviral medicines for at least four weeks.
Estonian: Viiendas uuringus võrreldi Epiviri või platseebo (näiva ravimi) toimet lisamisel olemasolevale HIVnakkuse ravile 1895 täiskasvanud patsiendil, kes olid võtnud viiruseravimeid vähemalt 4 nädalat.
English: In the first four studies in adults, Epivir, taken in combination with zidovudine, increased CD4 cell counts more than the comparator medicines after 24 weeks of treatment.
Estonian: Esimeses neljas täiskasvanute uuringus suurendas Epivir kasutamisel koos sidovudiiniga CD4-rakkude sisaldust pärast 24-nädalast ravi rohkem kui võrdlusravimid.
English: The studies examined the effects of Epivir on the levels of HIV in the blood (viral load) and the number of CD4 T-cells in the blood (CD4 cell count).
Estonian: Uuringutes vaadeldi Epiviri toimet HIV-sisaldusele veres (viiruskoormus) ja CD4-T-rakkude sisaldusele veres (CD4-rakkude sisaldus).
English: The oral solution can be used to achieve the appropriate dose.
Estonian: Vajaliku annuse saavutamiseks tohib kasutada suukaudset lahust.
English: For the full list of all side effects and restrictions with Epivir, see the package leaflet.
Estonian: Epiviri kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: The study measured how long the patients lived without their disease getting worse.
Estonian: Uuringus oli efektiivsuse põhinäitaja progresseerumiseta elulemus (aeg, kui kaua patsiendid elasid haiguse süvenemiseta).
English: What is the risk associated with Epivir?
Estonian: Mis riskid Epiviriga kaasnevad?
English: Why has Epivir been approved?
Estonian: Miks Epivir heaks kiideti?
English: In children weighing less than 25 kg the recommended dose depends on their weight.
Estonian: Alla 25 kg kehamassiga laste soovitatav annus oleneb kehamassist.
English: Treatment with Epivir should be started by a doctor who has experience in the management of HIV infection.
Estonian: Ravi Epiviriga tohib alustada üksnes HIV-nakkuse ravis kogenud arst.
English: The active substance in Epivir, lamivudine, is a nucleoside reverse transcriptase inhibitor (NRTI).It works by blocking the activity of reverse transcriptase, an enzyme needed by HIV to produce the genetic instructions for making more viruses once it has infected the cell.
Estonian: Epiviri toimeaine lamivudiin on nukleosiid-pöördtranskriptaasi inhibiitor (NRTI), mis blokeerib HIV-i tekitatava ensüümi pöördtranskriptaasi.
English: Epivir is used in combination with other antiviral medicines to treat patients infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).
Estonian: Epiviri kasutatakse koos teiste viiruseravimitega, et ravida täiskasvanuid ja lapsi, kellel on inimese immuunpuudulikkuse viiruse (HIV) nakkus.
English: Four of these studies compared Epivir in combination with zidovudine (another antiviral medicine) to either Epivir or zidovudine alone, or to the combination of Epivir and zalcitabine (another antiviral medicine).
Estonian: Neist neljas uuringus võrreldi Epiviri kasutamist koos sidovudiiniga (samuti viiruseravim) ainult Epiviri või ainult sidovudiini kasutamisega või Epiviri kasutamisega koos saltsitabiiniga (samuti viiruseravim).
English: What benefit has Epivir shown during the studies?
Estonian: Milles seisneb uuringute põhjal Epiviri kasulikkus?
English: The study compared the effects of Epivir taken with zidovudine to didanosine (another antiviral medicine) taken alone.
Estonian: Uuringus võrreldi Epiviri toimet ravimi kasutamisel koos sidovudiiniga ainult didanosiini kasutamisega (samuti viiruseravim).
English: The dose of Epivir needs to be adjusted in patients who have severe kidney problems.
Estonian: Raskete neeruprobleemidega patsientidel on vaja Epiviri annust kohandada.
English: How is Epivir used?
Estonian: Kuidas Epiviri kasutatakse?
English: What is Epivir used for?
Estonian: Milleks Epiviri kasutatakse?
English: How has Epivir been studied?
Estonian: Kuidas Epiviri uuriti?
English: How does Epivir work?
Estonian: Kuidas Epivir toimib?
English: Annual.
Estonian: Iga-aastane.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of the first authorisation: 17/12/2010
Estonian: Esmase müügiloa väljastamise kuupäev: 17/12/2010 Müügiloa uuendamise kuupäev:
English: a) the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Estonian: a) veterinaarravimi manustamine loomadele segab veterinaarhaiguste diagnoosimise, kontrolli või haigustõrje riiklike programmide rakendamist või komplitseerib nakkuste puudumise tõendamist elusloomadel või toiduainetes või muudes toodetes, mis on saadud loomadelt, kellele on manustatud ravimit;
English: MERIAL Animal Health Limited Biological Laboratory, Ash Road, Pirbright, Woking, Surrey GU24 0NQ United Kingdom
Estonian: MERIAL Animal Health Limited Biological Laboratory, Ash Road, Pirbright, Woking, Surrey GU24 0NQ Ühendkuningriigid
English: Special precautions for use in animals: Vaccinate healthy animals only.
Estonian: Ettevaatusabinõud kasutamisel loomadel: Vaktsineeritakse ainult terveid loomi.
English: The duration of immunity for cattle and sheep is 1 year after the primary vaccination course.
Estonian: Immuunsuse kestus veistel ja lammastel on 1 aasta pärast esmast vaktsineerimiskuuri.
English: Onset of immunity has been demonstrated 3 weeks after the primary vaccination course.
Estonian: Immuunsuse teke 3 nädalat pärast esmast vaktsineerimiskuuri.
English: Overdose (symptoms, emergency procedures, antidotes):
Estonian: 4.10 Üleannustamine (sümptomid, esmaabi, antidoodid), vajadusel
English: Pharmacotherapeutic group: bluetongue virus vaccine, ATCvet code QI04AA02 (sheep) and QI02AA08 (cattle).
Estonian: Farmakoterapeutiline rühm: lammaste katarraalse palaviku (Bluetongue) viiruse vaktsiin, ATCvet kood: QI04AA02 (lammastel) ja QI02AA08 (veistel)
English: Protect from light.
Estonian: Hoida valguse eest kaitstult
English: *(below the level of detection by the validated RT-PCR method at 3.68 log10 RNA copies/ml, indicating no infectious virus transmission).
Estonian: *( RT-RCP meetodil hinnatud ning allpool tuvastamispiiri, tasemel 3,68 log10 RNA koopiat/ml, viidates mittenakkuslikule viiruse kandumisele).
English: If used in other domestic and wild ruminant species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of animals prior to mass vaccination.
Estonian: Kui vaktsiini soovitakse kasutada teistel kodu- ja metsmäletsejalistel, keda peetakse nakatumisohtlikuks, tuleb seda teha ettevaatlikult ning enne massilist vaktsineerimist on soovitav testida vaktsiini väikesel arvul loomadel.
English: Shelf life after first opening the immediate packaging: immediately Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP:
Estonian: Kõlblikkusaeg pärast pakendi esmast avamist: kasutada koheselt Ärge kasutage seda ravimit pärast kõlblikkusaega, mis on märgitud sildil pärast {EXP }.