FrancophonIA/ELRC3.0 huggingface dataset:
English: No previous treatment with a PARP inhibitor, including olaparib, was permitted.
Icelandic: Sjúklingar máttu ekki áður hafa fengið meðferð með PARP hemli, þ.m.t. olaparibi.
English: There are limited clinical data available in non-Caucasian patients.
Icelandic: Takmarkaðar klínískar upplýsingar liggja fyrir um sjúklinga af öðrum kynþætti en hvítum.
English: The primary endpoint was PFS (progression-free survival) based on investigator assessment using RECIST 1.0.
Icelandic: Aðalendapunktur var lifun án versnunar sjúkdóms (PFS), byggt á mati rannsóknalæknis samkvæmt
English: Hepatic impairment
Icelandic: Ágengur sjúkdómur við slembiröðun
English: Lynparza 100 mg film-coated tablets olaparib
Icelandic: Lynparza 100 mg filmuhúðaðar töflur olaparib
English: Lynparza 150 mg film-coated tablets olaparib
Icelandic: Lynparza 150 mg filmuhúðaðar töflur olaparib
English: A clinical study to evaluate the impact of itraconazole, a known CYP3A inhibitor, has shown that co-administration with olaparib increased mean olaparib Cmax by 42% (90% CI: 33-52%) and mean
Icelandic: Klínísk rannsókn sem var gerð til að meta áhrif itraconazols, þekkts CYP3A hemils, sýndi að samhliðagjöf með olaparibi jók meðal Cmax olaparibs um 42% (90% CI: 33-52%) og meðal AUC um 170% (90% CI: 144-197).
English: Figure 5 Study 19: Kaplan Meier plot of OS in the FAS (79% maturity) DCO 09 May 2016
Icelandic: Meier graf af heildarlifun hjá heildarþýðinu (79% fullnusta) lok gagnasöfnunar (DCO) 09. maí 2016
English: It is unknown whether olaparib or its metabolites are excreted in human milk.
Icelandic: Ekki er vitað hvort olaparib eða umbrotsefni þess skiljist út í brjóstamjólk kvenna.
English: An exposure-response relationship between olaparib and decreases in haemoglobin has been demonstrated.
Icelandic: Sýnt hefur verið fram á útsetningar-svörunar samband milli olaparibs og minnkunar blóðrauða.
English: Lynparza 100 mg film-coated tablets
Icelandic: Lynparza 100 mg filmuhúðaðar töflur
English: Lynparza 150 mg film-coated tablets
Icelandic: Lynparza 150 mg filmuhúðaðar töflur
English: Very common Dizziness, Headache, Dysgeusia
Icelandic: Mjög algengar Sundl, höfuðverkur, breytt bragðskyn
English: Component of a multipack, not to be sold separately.
Icelandic: 56 filmuhúðaðar töflur Hluti fjölpakkningar, má ekki selja sér.
English: Contraception in males
Icelandic: Lyfhrifamilliverkanir
English: o A test is used to find out whether you have BRCA-mutated breast cancer.
Icelandic: o Próf er gert til að ákvarða hvort þú ert með BRCA-stökkbreytt brjóstakrabbamein.
English: Table 3 Summary of primary objective outcome for patients with gBRCA1/2m PSR ovarian cancer in SOLO2
Icelandic: Tafla 3 Samantekt á aðalviðmiðum hjá sjúklingum með PSR krabbamein í eggjastokkum með BRCA1/2 stökkbreytingu í kímlínu í SOLO2
English: Within each SOC, preferred terms are arranged by decreasing frequency and then by decreasing seriousness.
Icelandic: Innan hvers líffæraflokks er kjörheitum raðað með lækkandi tíðni og síðan minni alvarleika.
English: 0 Olaparib 300 mg bd 0 Placebo bd
Icelandic: 0 Olaparib 300 mg x 2 á dag
English: If you are planning to breast-feed, tell your doctor.
Icelandic: Segðu lækninum ef þú ráðgerir að vera með barn á brjósti.
English: In the HR+ patient subgroup the confirmed ORR was 57% (46/81) in the olaparib arm and 33% (11/33) in the comparator arm. bd Twice daily; CI Confidence interval; DOR Duration of response; DCO Data cut off; HR Hazard ratio; HR+ Hormone receptor positive, ORR Objective response rate; OS overall survival; PFS progression-free survival; PFS2 Time to second progression or death, TNBC triple negative breast cancer.
Icelandic: CI = öryggisbil; DOR = lengd svörunar; DCO = lok gagnaöflunar; HR = áhættuhlutfall; HR+ = hormónaviðtaka jákvætt; ORR = hlutfallsleg svörun; OS = heildarlifun; PFS = lifun án versnunar sjúkdóms; PFS2 = tími fram að annarri versnun eða dauða; TNBC = þrefalt neikvætt brjóstakrabbamein.
English: The primary endpoint was PFS assessed by blinded independent central review (BICR) using RECIST 1.1.
Icelandic: Mat rannsakanda á PFS var stutt af blindaðri, sjálfstæðri, miðlægri endurskoðun með myndgreiningu (BICR) á PFS.
English: If pneumonitis is confirmed, Lynparza treatment should be discontinued and the patient treated appropriately.
Icelandic: á að hætta meðferð með Lynparza og hefja viðeigandi meðferð.
English: PAES: In order to further define the efficacy of olaparib in patients with platinum sensitive relapsed (PSR) non-germline BRCA mutated high grade ovarian cancer in the maintenance setting and investigate predictive biomarkers within this patient group, the MAH should submit the results of study D0816C00020 (OPINION), a phase IIIb single-arm, open-label, multicentre study of maintenance therapy in PSR non-germline BRCA mutated ovarian cancer patients who are in complete or partial response following platinum based chemotherapy.
Icelandic: D0816C00020 (OPINION), sem er IIIb. stigs einarma, opin, fjölsetra rannsókn á viðhaldsmeðferð hjá sjúklingum með platínunæmt krabbamein með stökkbreytt BRCA í eggjastokkum, ekki í kímlínu, sem tekur sig upp aftur, sem hafa svara að hluta til eða að fullu eftir krabbameinslyfjameðferð sem byggir á platínu.
English: bd Twice daily; OS Overall survival; DCO data cut off; CI confidence interval; TFST time from randomisation to start of first subsequent therapy or death.
Icelandic: OS = heildarlifun; DCO = lok gagnasöfnunar; CI = öryggisbil; TFST = tími frá slembiröðun fram að seinni meðferð sem kom í kjölfarið eða dauðsfalli.
English: The investigator assessment of PFS was supported with a blinded independent central radiological review of PFS (HR 0.25; 95% CI 0.18-0.35; p<0.0001; median 30.2 months for olaparib and 5.5 months placebo).
Icelandic: Mat rannsóknarlæknisins á lifun án versnunar sjúkdóms var í samræmi við blindaða óháða og miðlæga yfirferð á lifun án versnunar sjúkdóms með myndgreiningu (HR 0,25; 95% CI 0,18-0,35; p<0,0001; miðgildi 30,2 mánuðir á olaparibi samanborið við 5,5 mánuði á lyfleysu).
English: Stomatitis a, Upper abdominal pain
Icelandic: blóðflagnafæð a, hvítfrumnafæð
English: • maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
Icelandic: viðhaldsmeðferð hjá fullorðnum sjúklingum eftir bakslag platínunæms þekjufrumukrabbameins af hárri gráðu í eggjastokkum, eggjaleiðara eða frumkrabbamein í lífhimnu sem svara (algjör svörun eða svörun að hluta til) krabbameinslyfjameðferð sem byggist á platínu.
English: Table 1 Tabulated list of adverse reactions
Icelandic: Tafla 1 Yfirlit yfir aukaverkanir
English: Thrombocytopenia a, Leukopenia
Icelandic: AstraZeneca A/S Tlf:
English: Of patients treated with Lynparza, who entered the study with evidence of disease (target or non-target lesions at baseline), 15.0% experienced complete response compared with 9.1% of patients on placebo.
Icelandic: Lyfleysa x 2 á dag merki um sjúkdóm (meinsemdir í marklíffæri eða ekki í marklíffæri við upphaf) náðu 15,0% algjörri svörun borið saman við 9,1% sjúklinga sem fengu lyfleysu.
English: • feeling dizzy
Icelandic: • breytt bragðskyn
English: Probability of progression free survival
Icelandic: Líkindi lifunar án versnunar
English: Figure 1 Study 19: Kaplan-Meier plot of PFS in BRCA-mutated patients (53% maturity-investigator assessment)
Icelandic: Kaplan-Meier graf af lifun án versnunar sjúkdóms hjá sjúklingum með BRCA stökkbreytingu (53% fullnustumat rannsóknalæknis)
English: No statistically significant differences were observed between olaparib and placebo in patient reported symptoms or HRQoL as measured by improvement and worsening rates in the FACT/NCCN Ovarian Symptom Index (FOSI), Trial Outcome Index (TOI) and Functional Analysis of Cancer TherapyOvarian total score (FACT-O total).
Icelandic: Index (TOI) og heildarskori á Functional Analysis of Cancer Therapy-Ovarian (FACT-O total).
English: 51.3%; including 20 patients identified with a somatic tumour BRCA1/2 mutation) as the subgroup that derived the greatest clinical benefit from olaparib maintenance monotherapy.
Icelandic: Fyrirfram áformuð undirhópagreining skilgreindi sjúklinga með krabbamein í eggjastokkum með BRCA1/2 stökkbreytingu (n=136, 51,3%, þ.m.t 20 sjúklingar með BRCA1/2 stökkbreytingu í líkamsfrumuæxli (somatic tumour BRCA1/2 mutation)) sem þann undirhóp sem hlyti mestan klínískan ávinning af olaparib einlyfjaviðhaldsmeðferð.
English: Number of events: Total number of patients (%) 102:260 (39) Median time (months)
Icelandic: Heildarfjöldi sjúklinga (%) Miðgildistími (mánuðir)
English: Absorption
Icelandic: Greining
English: Placebo
Icelandic: TNBC
English: Figure 6 OlympiAD: Kaplan-Meier plot of BICR PFS in patients with gBRCA1/2-mutated HER2-negative metastatic breast cancer (77% maturity) DCO 09 December 2016
Icelandic: Kaplan-Meier graf fyrir blindað, sjálfstætt meðlægt mat (BICR) yfir lifun án sjúkdómsversnunar (PFS) hjá sjúklingum með gBRCA1/2-stökkbreytt HER2-neikvætt brjóstakrabbamein með meinvörpum (77% fullnusta).
English: Data demonstrating clinical validation of tumour BRCA1/2 tests in breast cancer are not currently available.
Icelandic: á BRCA1/2 prófi fyrir brjóstakrabbamein eru sem stendur ekki fyrirliggjandi.
English: Metabolism and nutrition disorders
Icelandic: meltingartruflanir eða brjóstsviði
English: Date of first authorisation: 16 December 2014 Date of latest renewal:
Icelandic: Nýjasta dagsetning endurnýjunar markaðsleyfis:
English: Proportion of patients alive progression during platinum treatment and in the (neo)adjuvant setting provided the last dose was received at least 12 months prior to randomisation.
Icelandic: Fyrri meðferð byggð á platínu var leyfð þegar meinvörp voru til staðar ef engin vísbending var um versnun sjúkdóms meðan á meðferð sem byggist á platínu stóð og sem for- eða viðbótarmeðferð ef seinasti skammtur var gefinn að minnsta kosti 12 mánuðum fyrir slembiröðun.
English: Gastrointestinal toxicities
Icelandic: Eiturverkanir frá meltingarvegi
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Icelandic: Olaparib hamlar útflæðis flutningspróteininu
English: Common Stomatitis
Icelandic: YTRI UMBÚÐUM
English: Paediatric population No studies have been conducted to investigate the pharmacokinetics of olaparib in paediatric patients.
Icelandic: Börn Rannsóknir á lyfjahvörfum olaparibs hjá börnum hafa ekki verið gerðar.
English: Previous taxane treatment in (neo)adjuvant setting metastatic setting
Icelandic: Fyrri meðferð með taxani sem for- eða viðbótarmeðferð með meinvörpum
English: Anaemia includes preferred terms (PTs) of anaemia, anaemia macrocytic, erythropenia, haematocrit decreased, haemoglobin decreased, normochromic anaemia, normochromic normocytic anaemia, normocytic anaemia and red blood cell count decreased; Neutropenia includes PTs of agranulocytosis, febrile neutropenia, granulocyte count decreased, granulocytopenia, idiopathic neutropenia, neutropenia, neutropenic infection, neutropenic sepsis and neutrophil count decreased; Thrombocytopenia includes PTs of platelet count decreased, platelet production decreased, plateletcrit decreased and thrombocytopenia; Leukopenia includes PTs of leukopenia and white blood cell count decreased; Lymphopenia includes PTs of B-lymphocyte count decreased, lymphocyte count decreased, lymphopenia and T-lymphocyte count decreased; Cough includes PTs of cough and productive cough; Rash includes PTs of exfoliative rash, generalised erythema, rash, rash erythematous, rash generalised, rash macular, rash maculo-papular, rash papular and rash pruritic; Hypersensitivity includes PTs of drug hypersensitivity and hypersensitivity; Dermatitis includes PTs of dermatitis, dermatitis allergic and dermatitis exfoliative.
Icelandic: Daufkyrningafæð nær yfir kjörheitin kyrningaþurrð (agranulocytosis), daufkyrningafæð með hita, fækkun kyrninga, kyrningafæð, daufkyrningafæð af óþekktum orsökum, daufkyrningafæð, daufkyrningafæð með sýkingu, daufkyrningafæð með sýklasótt og fækkun daufkyrninga.
English: • if you have low blood cell counts on testing.
Icelandic: ef komið hefur í ljós í blóðprufum að þú ert með of fá blóðkorn.
English: What you need to know before you take Lynparza
Icelandic: Áður en byrjað er að nota Lynparza
English: Patients with BRCA1/2 mutations were identified either from germline testing in blood via a local test or by central testing at Myriad or from testing a tumour sample using a local test. Large rearrangements in the BRCA1/2 genes were detected in 4.7% (14/295) of the randomised patients.
Icelandic: Sjúklingar með BRCA1/2 stökkbreytingar voru greindir annaðhvort með prófun á kímlínu í blóði með staðbundinni prófun eða miðlægri prófun á Myriad eða með prófun á æxlissýni með staðbundinni prófun.
English: AstraZeneca UK Limited Tel: +386 1 51 35 600
Icelandic: AstraZeneca UK Ltd Tel: +44 1582 836 836
English: 200 mg Powder for concentrate for solution for infusion
Icelandic: 200 mg Stofn fyrir innrennslisþykkni, lausn
English: Blister(Alu/Alu)
Icelandic: Þynnupakkning (ál/ál)
English: 14 Capsules
Icelandic: 14 hylki
English: 100 mg Capsule, hard Oral use
Icelandic: 100 mg Hart hylki
English: 6 (3 x 2) pre-filled syringes (multipack)
Icelandic: 6 (3 x 2) áfylltar sprautur (fjölpakkning)
English: Montanide ISA
Icelandic: Montaníð ISA
English: However, in some cases, swelling may persist for up to 4 weeks.
Icelandic: Þó verður í sumum tilvikum vart við að bólga vari í allt að 4 vikur.
English: ATCvet code: QI02AB .
Icelandic: QI02AB.
English: Protection of animals not vaccinated following this program has not been demonstrated.
Icelandic: Ekki hefur verið sýnt fram á vörn hjá dýrum sem ekki hafa verið bólusett samkvæmt þessari áætlun.
English: *Relative Potency Units (ELISA)
Icelandic: *Hlutfallslegar virknieiningar (ELISA)
English: This swelling will have disappeared or be clearly reduced in size by 17 days post vaccination.
Icelandic: Slík bólga hverfur eða minnkar verulega að umfangi á 17 dögum eftir bólusetningu.
English: The full immunisation program should be repeated with each gestation.
Icelandic: Endurtaka ætti fulla ónæmisáætlun við hverja meðgöngu.
English: Allow the vaccine to reach a temperature of +15 to + 25 °C before administration.
Icelandic: Látið bóluefnið ná hitastiginu +15 til + 25 °C fyrir bólusetningu.
English: Store and transport refrigerated (2 ºC - 8 °C) and protected from light.
Icelandic: Geymið og flytjið í kæli (2°C - 8°C) og varið ljósi.
English: Administer one dose (2 ml) by deep intramuscular injection in the neck muscles according to the following immunisation program:
Icelandic: Gefið einn skammt (2 ml) með djúpri inndælingu í hálsvöðva samkvæmt eftirfarandi ónæmisáætlun:
English: This should be considered in case of herd vaccination.
Icelandic: Þetta þarf að hafa í huga við bólusetningu á hjörð.
English: Immunisation has to be considered as one component in a complex intramammary infection 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 and health monitoring) and other management practices.
Icelandic: Líta verður á ónæmisaðgerð sem einn þátt varnaráætlunar gegn samsettri júgurbólgu sem tekur á öllum mikilvægum heilsufarsatriðum júgurs (t.d. mjólkurtækni, þurrkun og undaneldi, hreinlæti, næringu, húsakynnum, undirburði, vellíðan kúnna, loft- og vatnsgæðum og heilsuvöktun) og öðrum búrekstri.
English: LTA from BAC of Streptococcus uberis, strain 5616 Relative Potency ≥ 1 RPU
Icelandic: Lipoteichoic-sýra (LTA) úr BAC-þætti Streptococcus uberis, stofn 5616 hlutfallsleg virkni ≥ 1 RPU
English: A transient increase in rectal temperature (mean increase of 1°C but may be up to 2°C in individual animals) may very commonly occur in the first 24 hours after injection.
Icelandic: Skammvinn aukning á hitastigi í endaþarmi (meðalaukning sem nemur 1 °C en getur verið allt að 2 °C hjá einstökum dýrum) getur oft átt sér stað á fyrstu 24 klukkustundunum eftir inndælingu.
English: - 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)
Icelandic: - Mjög algengar (aukaverkanir koma fyrir hjá fleiri en 1 af hverjum 10 dýrum sem fá meðferð) - Algengar (koma fyrir hjá fleiri en 1 en færri en 10 af hverjum 100 dýrum sem fá meðferð) - Sjaldgæfar (koma fyrir hjá fleiri en 1 en færri en 10 af hverjum 1.000 dýrum sem fá meðferð) - Mjög sjaldgæfar (koma fyrir hjá fleiri en 1 en færri en 10 af hverjum 10.000 dýrum sem fá meðferð)
English: 1 dose (2 ml) 5 doses (10 ml)
Icelandic: 1 skammtur (2 ml) 5 skammtar (10 ml)
English: Monophosphoryl Lipid A (MPLA)
Icelandic: Mónófosfórýl-lípíð A (MPLA)
English: Lipoteichoic acid (LTA) from Biofilm Adhesion Component (BAC) of Streptococcus uberis, strain 5616 .................................................................................................................................. ≥ 1 RPU*
Icelandic: Lipoteichoic-sýru (LTA) úr BAC-þætti (Biofilm Adhesion Component) Streptococcus uberis, stofn 5616 ............................................................................................................................................
English: Onset of immunity: approximately 36 days after the second dose.
Icelandic: Ónæmi myndast: um það bil 36 dögum eftir gjöf seinni skammtsins.
English: In a multicentre field study, the incidence of new cases of Streptococcus uberis clinical intramammary infection in the group vaccinated with UBAC was 50% lower than the incidence in the placebo group (6.1% versus 12.2%) which was statistically significantly different (p=0.012).
Icelandic: Í fjölsetra vettvangsrannsókn, var tíðni nýrra tilfella af klínískri júgurbólgu af völdum Streptococcus uberis í hópnum sem var bólusettur með UBAC 50% lægri en tíðnin í lyfleysuhópnum (6,1% samanborið við 12,2%) sem var tölfræðilega marktæktur munur (p=0,012).
English: Type I colourless glass vials of 3 ml.
Icelandic: Gerð I af 3 ml litlausum hettuglösum úr gleri.
English: Subunit vaccine to stimulate active immunity against Streptococcus uberis.
Icelandic: Undirbóluefni til að örva virkt ónæmi gegn Streptococcus uberis.
English: 25 doses (1 vial of 50 ml) 50 doses (1 vial of 100 ml) 25 doses (50 ml) 50 doses (100 ml)
Icelandic: 5 skammtar (1 hettuglas með 10 ml) 25 skammtar (1 hettuglas með 50 ml) 50 skammtar (1 hettuglas með 100 ml) 25 skammtar (50 ml) 50 skammtar (100 ml)
English: Shake before use.
Icelandic: Hristist vel fyrir notkun.
English: Polyethylene (PET) vials of 10, 50 and 100 ml.
Icelandic: Pólýetýlen (PET) hettuglös, 10, 50 og 100 ml.
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Icelandic: Leitið ráða hjá dýralækni í apóteki um hvernig heppilegast er að farga lyfjum sem hætt er að nota.
English: 20 x 1 dose (1 vial of 2 ml)
Icelandic: 20 x 1 skammtur (1 hettuglas með 2 ml)
English: The injections should be preferably administered on the alternate sides of the neck.
Icelandic: Gefa ætti bóluefnið á hvorri hlið hálsins til skiptis.
English: Special warnings for each target species: Only healthy animals should be immunised.
Icelandic: Sérstakar varúðarreglur við notkun hjá dýrum Bólusetjið aðeins heilbrigð dýr.
English: Cardboard box with 1 PET vial of 5, 25 and 50 doses.
Icelandic: Pappaaskja með 1 PET hettuglas með 5, 25 og 50 skömmtum.
English: Date of first authorisation: <{DD/MM/YYYY}>
Icelandic: Dagsetning fyrstu útgáfu markaðsleyfis: {DD/MM/ÁÁÁÁ}.
English: Pregnancy and Lactation:
Icelandic: Meðganga og mjólkurgjöf:
English: Carretera C63 Km 48, 300, Poligono Industrial El Rieral 17170 Amer (Girona) Spain
Icelandic: Carretera C63 Km 48,300, Polígono Industrial
English: Cardboard box with 20 glass vials of 1 dose (2 ml).
Icelandic: Pappaaskja með 20 hettuglösum með 1 skammti (2 ml).
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals: To the user:
Icelandic: Sérstakar varúðarreglur fyrir þann sem gefur dýrinu lyfið Upplýsingar fyrir þann sem annast lyfjagjöfina:
English: Potassium chloride
Icelandic: Tvínatríumfosfatdódekahýdrat
English: Name and address of the manufacturer responsible for batch release: Laboratorios Hipra, S.A.
Icelandic: Heiti og heimilisfang framleiðenda sem eru ábyrgir fyrir lokasamþykkt Laboratorios Hipra, S.A.
English: Pharmacotherapeutic group: Immunologicals for bovidae, inactivated bacterial vaccines for cattle.
Icelandic: Flokkun eftir verkun: Ónæmislyf handa slíðurhyrningum (bovidae).
English: UBAC emulsion for injection for cattle.
Icelandic: UBAC stungulyf, fleyti fyrir nautgripi.
English: Duration of immunity: approximately the first 5 months of lactation.
Icelandic: Ónæmi endist í: um það bil 5 mánuði frá upphafi mjólkurgjafar.
English: Cardboard box with 20 glass vials of 1 dose.
Icelandic: Pappaaskja með 20 hettuglösum með 1 skammti.
English: Local swelling more than 5 cm in diameter at the injection site is a very common reaction after administration of the vaccine.
Icelandic: Algeng viðbrögð eru að bólga, sem er meira en 5 cm í þvermál, myndast á íkomustað eftir bólusetningu.
English: UBAC emulsion for injection for cattle
Icelandic: UBAC stungulyf, fleyti fyrir nautgripi
English: Sodium chloride
Icelandic: Kalíumtvívetnisfosfat
English: Bearing in mind that some cows had suffered more than one episode of Streptococcus uberis clinical intramammary infection, the incidence of cows with clinical intramammary infection was 52.5% lower in the vaccinated group than those of the placebo group (4.7% versus 9.9%), with a statistical significance of p<0.017.
Icelandic: 52,5% lægri hjá bólusetta hópnum en hjá lyfleysuhópnum (4,7% versus 9,9%), með tölfræðilegri marktækni p<0,017.
English: Vial of 25 and 50 doses.
Icelandic: Hettuglas með 25 og 50 skömmtum.
English: For active immunisation of healthy cows and heifers to reduce the incidence of clinical intramammary infections caused by Streptococcus uberis, to reduce the somatic cell count in
Icelandic: Til virkrar ónæmingar hjá heilbrigðum kúm og kvígum til að draga úr tíðni klínískrar júgurbólgu af völdum Streptococcus uberis, í þeim tilgangi að minnka frumutölu í Streptococcus uberis jákvæðum mjólksýnum úr júgurfjórðungum og til að draga úr minnkaðri mjólkurmyndun vegna júgurbólgu af völdum Streptococcus uberis.
English: 5616 ≥ 1 RPU* *Relative Potency Units (ELISA)
Icelandic: ≥ 1 RPU*
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals To the user:
Icelandic: Sérstakar varúðarreglur fyrir þann sem gefur dýrinu lyfið:
English: La Selva, 135 17170 Amer (Girona) Spain
Icelandic: El Rieral 17170 Amer (Girona) Spain
English: Cardboard box with 1 PET vial of 50 doses (100 ml).
Icelandic: Pappaaskja með 1 PET hettuglas með 50 skömmtum (100 ml).
English: Cardboard box with 1 PET vial of 25 doses (50 ml).
Icelandic: Pappaaskja með 1 PET hettuglas með 25 skömmtum (50 ml).
English: Cardboard box with 1 PET vial of 5 doses (10 ml).
Icelandic: Pappaaskja með 1 PET hettuglas með 5 skömmtum (10 ml).
English: - Second dose at least 21 days before the expected parturition date - Third dose should be administered about 15 days after the calving.
Icelandic: - Þriðja skammt skal gefa um 15 dögum eftir burð.
English: Streptococcus uberis intramammary infections.
Icelandic: Dýralyfið inniheldur paraffínolíu.
English: Tel: (+49) 211 698236 - 0
Icelandic: HIPRA DEUTSCHLAND GmbH Tel: (+49) 211 698236 - 0
English: LABORATORIOS HIPRA, S.A. Avda.
Icelandic: LABORATORIOS HIPRA, S.A. Avda. la Selva, 135
English: Overdose (symptoms, emergency procedures, antidotes): No information is available.
Icelandic: Ofskömmtun (einkenni, bráðameðferð, móteitur):
English: Sanitários De Uso Animal, Lda
Icelandic: LÍFFRÆÐILEGRA VIRKRA EFNA
English: Monophosphoryl Lipid A (MPLA) Disodium phosphate dodecahydrate Potassium dihydrogen phosphate
Icelandic: UBAC stungulyf, fleyti handa nautgripum
English: Water for injections
Icelandic: OG AÐFERÐ VIÐ LYFJAGJÖF
English: (Invented) name Strength Pharmaceutical Form
Icelandic: ESB makaðsleyfisnúmer