FrancophonIA/ELRC3.0 huggingface dataset:
English: AUC ↔ 1.15 (1.09-1.21) Cmin ↑ 1.19 (1.13-1.26) Cmax ↑ 1.15 (1.04-1.27) etravirine
Icelandic: AUC ↔ 1,15 (1,09-1,21) Cmin ↑ 1,19 (1,13-1,26) Cmax ↑ 1,15 (1,04-1,27) etravirin
English: Concomitant use of etravirine with indinavir may cause a significant decrease in the plasma concentration of indinavir and loss of therapeutic effect of indinavir.
Icelandic: Samhliða notkun etravirins og indinavirs getur valdið marktækri lækkun á plasmaþéttni indinavirs og getur dregið úr verkun indinavirs.
English: No significant effect on tenofovir and etravirine PK parameters is seen.
Icelandic: Engin marktæk áhrif á lyfjahvörf tenofovirs og etravirins hafa komið fram.
English: Etravirine is expected to increase plasma concentrations of warfarin.
Icelandic: Get er ráð fyrir að etravirin auki plasmaþéttni warfaríns.
English: Etravirine 200 mg twice daily 2
Icelandic: Etravirin 200 mg tvisvar á sólarhring
English: This will improve your immune system and reduces the risk of developing illnesses linked to HIV infection.
Icelandic: INTELENCE vinnur gegn HIVsýkingu með því að draga úr veirufjöldanum í líkamanum, en við það styrkist ónæmiskerfið sem aftur dregur úr hættu á sjúkdómum sem tengjast HIV-sýkingu.
English: If a patient vomits more than 4 hours after taking the medicine, the patient does not need to take another dose until the next regularly scheduled time.
Icelandic: eftir töku lyfsins þarf ekki að taka annan skammt fyrr en komið er að næsta skammti samkvæmt áætlun.
English: The population pharmacokinetic estimates for etravirine AUC12h and C0h are summarised in the table below.
Icelandic: Mat á lyfjahvörfum hjá ákveðnum hópum fyrir etravirin AUC12klst. og C0klst.
English: AUC ↓ 0.47 (0.38-0.58) Cmin ↓ 0.61 (0.53-0.71) Cmax ↓ 0.40 (0.28-0.57) etravirine
Icelandic: AUC ↓ 0,47 (0,38-0,58) Cmin ↓ 0,61 (0,53-0,71) Cmax ↓ 0,40 (0,28-0,57) etravirin
English: AUC ↔ 0.95 (0.64-1.42) Cmin ↓ 0.80 (0.46-1.38) Cmax ↔ 1.00 (0.70-1.42) etravirine
Icelandic: AUC ↔ 0,95 (0,64-1,42) Cmin ↓ 0,80 (0,46-1,38) Cmax ↔ 1,00 (0,70-1,42) etravirin
English: AUC ↓ 0.62 (0.48-0.80) Cmin ↓ 0.82 (0.67-1.01) Cmax ↓ 0.72 (0.55-0.94) dihydroartemisinin AUC ↓ 0.85 (0.75-0.97) Cmin ↓ 0.83 (0.71-0.97) Cmax ↓ 0.84 (0.71-0.99) lumefantrine AUC ↓ 0.87 (0.77-0.98) Cmin ↔ 0.97 (0.83-1.15) Cmax ↔ 1.07 (0.94-1.23) etravirine
Icelandic: AUC ↓ 0,62 (0,48-0,80) Cmin ↓ 0,82 (0,67-1,01) Cmax ↓ 0,72 (0,55-0,94) dihydroartemisinin AUC ↓ 0,85 (0,75-0,97) Cmin ↓ 0,83 (0,71-0,97) Cmax ↓ 0,84 (0,71-0,99) lumefantrin
English: The plastic bottle comes with a child resistant cap and should be opened as follows: Push the plastic screw cap down while turning it counter clockwise.
Icelandic: Plastglasið er með barnaöryggisloki sem er opnað á eftirfarandi hátt:
English: Each tablet of INTELENCE contains 200 mg of etravirine.
Icelandic: Hver tafla af INTELENCE inniheldur 200 mg af etravirini.
English: INTELENCE 100 mg tablets etravirine
Icelandic: INTELENCE 100 mg töflur etravirin
English: Lovastatin, rosuvastatin and simvastatin are CYP3A4 substrates and co-administration with etravirine may result in lower plasma concentrations of the HMG Co-A reductase inhibitor.
Icelandic: Lovastatin, rosuvastatin og simvastatin eru CYP3A4 hvarfefni og samhliða gjöf þeirra og etravirins gæti leitt til lægri plasmaþéttni HMG Co-A redúktasahemlanna.
English: Janssen-Cilag, S.A. Tel: +34 91 722 81 00 infojaces@its.jnj.com
Icelandic: +34 91 722 81 00 infojaces@its.jnj.com
English: dolutegravir AUC↓ 0.75 (0.69-0.81) Cmin ↓ 0.63 (0.52-0.77) Cmax ↓ 0.88 (0.78-1.00) etravirine
Icelandic: dolutegravir AUC↓ 0,75 (0,69-0,81) Cmin ↓ 0,63 (0,52-0,77) Cmax ↓ 0,88 (0,78-1,00) etravirin
English: Each tablet contains 25 mg of etravirine.
Icelandic: Hver tafla inniheldur 25 mg af etravirini.
English: Fluvastatin, and rosuvastatin are metabolised by CYP2C9 and co-administration with etravirine may result in higher plasma concentrations of the HMG Co-A reductase inhibitor.
Icelandic: Fluvastatin, og rosuvastatin umbrotna fyrir tilstilli CYP2C9 og samhliða gjöf þeirra og etravirins getur leitt til hærri plasmaþéttni HMG Co-A redúktasahemlanna.
English: Janssen-Cilag AB Tfn: +46 8 626 50 00 jacse@its.jnj.com
Icelandic: +46 8 626 50 00 jacse@its.jnj.com
English: In healthy subjects, the absorption of etravirine is not affected by co-administration of oral ranitidine or omeprazole, medicinal products that are known to increase gastric pH.
Icelandic: Hjá heilbrigðum einstaklingum hefur samhliða gjöf ranitidins eða ómeprazóls til inntöku ekki áhrif á frásog etravirins, en þekkt er að þessi lyf hækka sýrustig í maga.
English: (Hypericum perforatum)
Icelandic: JURTALYF Jóhannesarjurt (Hypericum perforatum)
English: Each tablet of INTELENCE contains 100 mg of etravirine.
Icelandic: Hver tafla af INTELENCE inniheldur 100 mg af etravirini.
English: INTELENCE and lopinavir/ritonavir can be used without dose adjustments.
Icelandic: INTELENCE og lopinavir/ritonavir má nota án aðlögunar skammta.
English: INTELENCE contains the active substance etravirine.
Icelandic: INTELENCE inniheldur virka efnið etravirin.
English: The pharmacokinetics of etravirine in paediatric patients less than 6 years of age are under investigation.
Icelandic: Rannsókn stendur yfir á lyfjahvörfum etravirins hjá börnum yngri en 6 ára.
English: In all the other trials conducted with etravirine in HIV-1 infected patients, the following mutations emerged most commonly: L100I, E138G, V179F, V179I, Y181C and H221Y.
Icelandic: L100I, E138G, V179F, V179I, Y181C og H221Y.
English: 200 mg twice daily eight 25 mg tablets twice daily or two 100 mg tablets twice daily or one 200 mg tablet twice daily
Icelandic: Átta 25 mg töflur tvisvar á sólarhring eða tvær 100 mg töflur tvisvar á sólarhring eða ein 200 mg tafla tvisvar á sólarhring
English: Excipient with known effect Each tablet contains less than 1 mmol sodium (23 mg), and is essentially sodium-free.
Icelandic: INTELENCE inniheldur natríum Lyfið inniheldur minna en 1 mmól (23 mg) af natríum í hverri töflu, þ.e.a.s. er sem næst natríumlaust.
English: Tablet White to off-white, biconvex, oblong tablet debossed with “T200” on one side.
Icelandic: Hvít eða beinhvít tvíkúpt, ílöng tafla, með ígreyptu „T200“ á annarri hliðinni.
English: Fusion Inhibitors Enfuvirtide 90 mg twice daily etravirine*
Icelandic: 90 mg tvisvar á sólarhring etravirin*
English: No significant effect on didanosine and etravirine PK parameters is seen.
Icelandic: Engin marktæk áhrif á lyfjahvörf didanosins og etravirins hafa komið fram.
English: For instructions on dispersion of the medicinal product before administration, see section 6.6.
Icelandic: Sjá leiðbeiningar í kafla 6.6 um hvernig má leysa lyfið upp fyrir gjöf.
English: AUC ↓ 0.90 (0.68-1.18) Cmin ↓ 0.66 (0.34-1.26) Cmax ↓ 0.89 (0.68-1.15) etravirine
Icelandic: AUC ↓ 0,90 (0,68-1,18) Cmin ↓ 0,66 (0,34-1,26) Cmax ↓ 0,89 (0,68-1,15) etravirin
English: AUC ↔ 1.03 (0.90-1.18) Cmin ↓ 0.87 (0.75-1.02) Cmax ↔ 1.06 (0.95-1.20) etravirine
Icelandic: AUC ↔ 1,03 (0,90-1,18) Cmin ↓ 0,87 (0,75-1,02) Cmax ↔ 1,06 (0,95-1,20) etravirin
English: 6 cells/l), mean (SE) and median (range) Change from baseline in CD4 percentage, median (range)
Icelandic: 6 frumur/l), meðalgildi (SE) og miðgildi (bil)
English: Psychiatric disorders common anxiety, insomnia, sleep disorders uncommon confusional state, disorientation, nightmares,
Icelandic: Ringlun, vistarfirring, martraðir, taugaveiklun, óeðlilegir draumar
English: 25 mg: EU/1/08/468/003 100 mg: EU/1/08/468/001 200 mg: EU/1/08/468/002
Icelandic: EU/1/08/468/001 200 mg:
English: PHOSPHODIESTERASE, TYPE 5 (PDE-5) INHIBITORS Sildenafil 50 mg single dose
Icelandic: FOSFÓDÍESTERASAHEMLAR AF GERÐ 5 (PDE-5)
English: Etravirine 200 mg twice daily postpartum N = 10
Icelandic: Etravirin 200 mg tvisvar á sólarhring þriðji þriðjungur N = 10
English: Removing the child resistant cap
Icelandic: Barnaöryggislokið fjarlægt
English: However, unbound concentrations have not been assessed.
Icelandic: Hins vegar hefur þéttni óbundins lyfs ekki verið metin.
English: An intravenous formulation of etravirine is unavailable, thus, the absolute bioavailability of etravirine is unknown.
Icelandic: Etravirin er ekki til í stungulyfi til gjafar í bláæð og því er raunaðgengi etravirins óþekkt.
English: Boosted protease inhibitors, like darunavir/ritonavir, show a higher barrier to resistance compared to other classes of antiretrovirals.
Icelandic: Örvaðir próteasahemlar, s.s. darunavir/ritonavir, hafa hærri þröskuld m.t.t. ónæmis en lyf í öðrum flokkum andretróveirulyfja.
English: Each tablet contains 100 mg of etravirine.
Icelandic: Hver tafla inniheldur 100 mg af etravirini.
English: Each tablet contains 200 mg of etravirine.
Icelandic: Hver tafla inniheldur 200 mg af etravirini.
English: Using the oral solution may be considered for dose reduction.
Icelandic: Íhuga má notkun mixtúru þegar skammtar eru minnkaðir.
English: Table 5: Proportion of subjects with < 50 HIV-1 RNA copies/ml at week 48 by baseline number of etravirine RAMs in the non-viral failure excluded population of pooled DUET-1 and DUET-2 trials Baseline number of Etravirine RAMs*
Icelandic: RNA eintök/ml í 48. viku samkvæmt fjölda etravirin RAM í upphafi í hópnum sem ekki var útilokaður, hafði ekki veirufræðilegan meðferðarbrest, í samanlögðum DUET-1 og DUET-2rannsóknunum Fjöldi etravirin RAM í upphafi*
English: Clarithromycin exposure was decreased by etravirine; however, concentrations of the active metabolite, 14-OH-clarithromycin, were increased.
Icelandic: Hins vegar jókst þéttni virka umbrotsefnisins, 14-OH-klaritrómýcíns.
English: Mean ± SD (median)
Icelandic: VIRK(T) EFNI
English: AUC ↓ 0.86 (0.79-0.93) Cmin ↓ 0.62 (0.55-0.71) Cmax ↔ 0.97 (0.89-1.05) etravirine
Icelandic: AUC ↓ 0,86 (0,79-0,93) Cmin ↓ 0,62 (0,55-0,71) Cmax ↔ 0,97 (0,89-1,05) etravirin
English: 125 mg twice daily five 25 mg tablets twice daily or one 100 mg tablet and one 25 mg tablet twice daily
Icelandic: Fimm 25 mg töflur tvisvar á sólarhring eða ein 100 mg tafla og ein 25 mg tafla tvisvar á sólarhring
English: Silicified microcrystalline cellulose Microcrystalline cellulose Colloidal anhydrous silica Croscarmellose sodium Magnesium stearate
Icelandic: LYF GEGN SÝKINGUM Andretróveirulyf NRTI-lyf Didanosin
English: Date of first authorisation: 28 August 2008 Date of latest renewal: 23 August 2018
Icelandic: 23. ágúst 2018.
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.8).
Icelandic: Hinsvegar er breytilegt hvenær það gerist og geta slík tilfelli komið fram mörgum mánuðum eftir upphaf meðferðar (sjá kafla 4.8).
English: Patients with coexisting conditions
Icelandic: Sjúklingar sem einnig hafa aðra sjúkdóma
English: In the rat, the key target organs identified were the liver, the thyroid and the coagulation system.
Icelandic: Hjá rottum voru marklíffærin lifur, skjaldkirtill og blóðstorkukerfið.
English: Co-administration is contraindicated (see section 4.3).
Icelandic: Ekki má gefa lyfin samhliða (sjá kafla 4.3).
English: What INTELENCE contains - The active substance is etravirine.
Icelandic: - Virka innihaldsefnið er etravirin.
English: The proportion of paediatric patients with < 400 HIV-1 RNA copies/ml was 63.4%.
Icelandic: RNA eintök/ml var 63,4%.
English: What INTELENCE looks like and contents of the pack This medicinal product is presented as white to off-white, oval tablet, with “T125” on one side and “100” on the other side.
Icelandic: Þetta lyf er hvít eða beinhvít sporöskjulaga tafla, merkt „T125“ á annarri hliðinni og „100“ á hinni hliðinni.
English: Please refer to the product information of the associated boosted PI for the dose adjustment of rifabutin to be used.
Icelandic: Nota skal upplýsingar í samantekt á eiginleikum lyfs fyrir viðkomandi örvaðan próteasahemil sem notaður er samhliða, til að áætla þá skammta af rifabutini sem nota á.
English: Immunologic parameters
Icelandic: Ónæmisfræðilegar breytur
English: Severe cutaneous adverse reactions have been reported with etravirine.
Icelandic: Greint hefur verið frá alvarlegum aukaverkunum í húð af völdum etravirins.
English: Reporting of suspected adverse reactions
Icelandic: Upplýsingar um notkun
English: Special populations
Icelandic: Óháð fjölda
English: In mice, the key target organs identified were the liver and the coagulation system.
Icelandic: Hjá músum voru helstu marklíffærin lifur og blóðstorkukerfið.
English: White to off-white, oval, scored tablet, debossed with “TMC” on one side.
Icelandic: Hvít eða beinhvít sporöskjulaga tafla með deiliskoru, með ígreyptu „TMC“ á annarri hliðinni.
English: C-etravirine dose, 93.7% and 1.2% of the administered dose of C-etravirine could be retrieved in faeces and urine, respectively.
Icelandic: C-etravirin-skammts skildust 93,7% af gefnum skammti af
English: Patients co-infected with hepatitis B and/or hepatitis C virus In the pooled analysis for DUET-1 and DUET-2, the incidence of hepatic events tended to be higher in co-infected subjects treated with etravirine compared to co-infected subjects in the placebo group.
Icelandic: C Í samanlagðri greiningu á DUET-1 og DUET-2 hafði tíðni aukaverkana á lifur tilhneigingu til að vera hærri hjá einstaklingum, sem einnig höfðu lifrarbólgusýkingu, í etravirinhópnum, en hjá sjúklingum, sem einnig höfðu lifrarbólgusýkingu, í lyfleysuhópnum.
English: ANTIARRHYTHMICS Digoxin
Icelandic: LYF VIÐ HJARTSLÁTTARÓREGLU Digoxín
English: Reporting of side effects
Icelandic: Samantekt á niðurstöðum um virkni
English: 1 mg once daily ethinylestradiol AUC ↑ 1.22 (1.13-1.31) Cmin ↔ 1.09 (1.01-1.18) Cmax ↑ 1.33 (1.21-1.46) norethindrone AUC ↔ 0.95 (0.90-0.99) Cmin ↓ 0.78 (0.68-0.90) Cmax ↔ 1.05 (0.98-1.12) etravirine
Icelandic: 1 mg einu sinni á sólarhring etinylestradiol AUC ↑ 1,22 (1,13-1,31) Cmin ↔ 1,09 (1,01-1,18) Cmax ↑ 1,33 (1,21-1,46) noretindron
English: 150 mg twice daily six 25 mg tablets twice daily or one 100 mg tablet and two 25 mg tablets twice daily
Icelandic: Sex 25 mg töflur tvisvar á sólarhring eða ein 100 mg tafla og tvær 25 mg töflur tvisvar á sólarhring
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Icelandic: Lýsing á útliti INTELENCE og pakkningastærðir
English: nervousness, abnormal dreams
Icelandic: Kvíði, svefnleysi, svefnraskanir
English: What INTELENCE looks like and contents of the pack This medicinal product is presented as white to off-white, oval, scored tablet, with “TMC” on one side.
Icelandic: Þetta lyf er hvít eða beinhvít sporöskjulaga tafla með deiliskoru, merkt „TMC“ á annarri hliðinni.
English: Median CD4 cell count
Icelandic: Upphafsgildi CD4 fjölda (x 10
English: The effect of etravirine on dolutegravir plasma concentrations was mitigated by co-administration of darunavir/ritonavir or lopinavir/ritonavir, and is expected to be mitigated by atazanavir/ritonavir.
Icelandic: Samhliða gjöf darunavirs/ritonavirs eða lopinavirs/ritonavirs dró úr áhrifum etravirins á plasmaþéttni dolutegravirs og búist er við að atazanavir/ritonavir dragi úr áhrifunum.
English: After administration of a radiolabeled
Icelandic: Eftir gjöf geislamerkts
English: CORTICOSTEROIDS Dexamethasone (systemic)
Icelandic: Dexametason (ekki útvortis)
English: Therefore, the pharmacokinetic parameter estimates shown in the table account for reductions in the pharmacokinetic parameters of etravirine due to co-administration of etravirine with darunavir/ritonavir.
Icelandic: Við matið á lyfjahvarfafræðilegum breytum sem koma fram í töflunni er þess vegna tekið tillit til minnkunar á lyfjahvarfafræðilegum breytum etravirins vegna samhliða notkunar etravirins og darunavirs/ritonavirs.
English: Most often, rash was mild to moderate, of macular/papular type, and occurred in the second week of therapy.
Icelandic: Algengast var að útbrotin væru væg eða miðlungsmikil dröfnuörðuútbrot sem komu fram í annarri viku meðferðar.
English: Stevens-Johnson Syndrome a, erythema multiforme very rare toxic epidermal necrolysis a, DRESS
Icelandic: Eitrunardreplos húðþekju a, DRESS
English: Geometric Mean ± Standard Deviation Median (Range)
Icelandic: Margfeldismeðaltal ± Staðalfrávik Miðgildi (bil)
English: With an associated boosted PI:
Icelandic: Með örvuðum próteasahemli:
English: Vascular disorders common hypertension rare haemorrhagic stroke
Icelandic: Hár blóðþrýstingur Mjög sjaldgæfar Blæðingarslag
English: What you need to know before you take INTELENCE
Icelandic: Áður en byrjað er að nota INTELENCE
English: Voriconazole 200 mg twice daily voriconazole AUC ↑ 1.14 (0.88-1.47) Cmin ↑ 1.23 (0.87-1.75) Cmax ↓ 0.95 (0.75-1.21) etravirine
Icelandic: AUC ↑ 1,14 (0,88-1,47) Cmin↑ 1,23 (0,87-1,75) Cmax ↓ 0,95 (0,75-1,21) etravirin
English: What INTELENCE looks like and contents of the pack This medicinal product is presented as white to off-white, biconvex, oblong tablet with “T200” on one side.
Icelandic: Þetta lyf er hvít eða beinhvít tvíkúpt, ílöng tafla, merkt „T200“ á annarri hliðinni.
English: Pharmacotherapeutic group: Antivirals for systemic use, non-nucleoside reverse transcriptase inhibitors, ATC code: J05AG04.
Icelandic: Veirusýkingalyf til almennrar verkunar, Bakritahemlar nema núkleósíð, ATC-flokkur:
English: Table 9: Pharmacokinetic results of total etravirine after administration of etravirine 200 mg twice daily as part of an antiretroviral regimen, during the 2
Icelandic: Niðurstöður lyfjahvarfa heildaretravirins eftir gjöf etravirins 200 mg tvisvar á sólarhring sem hluti af andretróveiru meðferðaráætlun, á öðrum þriðjungi meðgöngu, þriðja þriðjungi meðgöngu og eftir fæðingu.
English: At the highest tested doses, the systemic exposures
Icelandic: Innan tíðniflokka eru alvarlegustu aukaverkanirnar taldar upp fyrst.
English: St John's wort is expected to decrease the plasma concentrations of etravirine.
Icelandic: Gert er ráð fyrir að Jóhannesarjurt lækki plasmaþéttni etravirins.
English: Paediatric population
Icelandic: Ákveðnir sjúklingahópar
English: ≥ 20 to < 25 kg
Icelandic: ≥ 20 til < 25 kg 125 mg tvisvar á sólarhring
English: If you notice within 6 hours of the time you usually take INTELENCE, you must take the tablet as soon as possible.
Icelandic: INTELENCE venjulega, að þú hafir gleymt skammti áttu að taka töfluna án tafar.
English: Each tablet contains 25 mg etravirine.
Icelandic: Hver tafla inniheldur 25 mg etravirin.
English: Etravirine 200 mg twice daily N = 575
Icelandic: Etravirin 200 mg tvisvar á sólarhring annar þriðjungur N = 13
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
Icelandic: Samantekt á aukaverkunum sett upp í töflu
English: ≥ 25 to < 30 kg
Icelandic: ≥ 25 til < 30 kg 150 mg tvisvar á sólarhring
English: Etravirine is expected to increase nelfinavir plasma concentrations.
Icelandic: Gert er ráð fyrir að etravirin auki plasmaþéttni nelfinavirs.
English: 100 mg twice daily four 25 mg tablets twice daily or one 100 mg tablet twice daily
Icelandic: Fjórar 25 mg töflur tvisvar á sólarhring eða ein 100 mg tafla tvisvar á sólarhring
English: All ranges
Icelandic: Meðganga
English: Oral use.
Icelandic: TLOVR-algóritma.
English: 4.8 log10 copies/ml
Icelandic: 4,8 log10eintök/ml 4,8 log10eintök/ml Miðgildi CD4 frumufjölda
English: Paediatric population (6 years to less than 18 years of age) The recommended dose of etravirine for paediatric patients (6 years to less than 18 years of age and weighing at least 16 kg) is based on body weight (see table below).
Icelandic: Ráðlagður skammtur af etravirini fyrir börn (á aldrinum 6 ára til yngri en 18 ára og sem vega a.m.k.
English: Pregnancy
Icelandic: Enfuvirtid
English: PLATELET AGGREGGATION INHIBITORS Clopidogrel
Icelandic: LYF SEM HAMLA SAMLOÐUN BLÓÐFLAGNA Clopidogrel
English: The systemic exposure (AUC) to etravirine was decreased by about 50% when etravirine was administered under fasting conditions, as compared to administration following a meal.
Icelandic: 50% þegar etravirin var gefið á fastandi maga, samanborið við gjöf þess eftir máltíð.
English: Dolutegravir + darunavir/ritonavir 50 mg once daily + 600/100 mg twice daily
Icelandic: + Lopinavir/ritonavir 50 mg einu sinni á sólarhring
English: UAB "JOHNSON & JOHNSON" Eesti filiaal Tel: +372 617 7410 ee@its.jnj.com
Icelandic: +372 617 7410 ee@its.jnj.com
English: * based on population pharmacokinetic analyses
Icelandic: * byggt á greiningu á lyfjahvörfum ákveðinna hópa
English: Do not re-freeze under any circumstances.
Icelandic: Ekki skal undir neinum kringumstæðum frysta þær aftur.
English: No spread was demonstrated between chickens.
Icelandic: Ekki var sýnt fram á útbreiðslu milli kjúklinga.
English: Repeat it one or two times.
Icelandic: Þetta er svo endurtekið einu sinni eða tvisvar.
English: Date of first authorisation: 08/09/2015
Icelandic: Dagsetning fyrstu útgáfu markaðsleyfis: 08/09/2015.
English: The solvent is a clear red solution.
Icelandic: Leysirinn er tær, rauð lausn.
English: ATCvet code: QI01AD.
Icelandic: QI01AD.
English: Frozen glass ampoules may explode during sudden temperature changes.
Icelandic: Frosnar glerlykjur kunna að springa við skyndilegar hitabreytingar.
English: Five ampoules per cane.
Icelandic: Fimm lykjur á geymslustaf.
English: EXP {month/year}
Icelandic: EXP {mán/ár}
English: Do not use Vectormune ND if you notice visible signs of unacceptable decolourisation in the vials.
Icelandic: Ekki má nota Vectormune ND ef sýnilegar vísbendingar um óásættanlega aflitun í hettuglösum eru til staðar.
English: Chicken and embryonated chicken eggs.
Icelandic: Kjúklingar og frjóvguð hænuegg.
English: A slow spread to turkeys which was not detectable at 35 days but was detectable after 42 days of a contact study.
Icelandic: Hægfara útbreiðsla til kalkúna, sem ekki var greinanleg eftir 35 daga en var greinanleg við 42 daga í rannsókn á útbreiðslu.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Icelandic: Hjálparefnin (þ.m.t. ónæmisglæðar) sem talin eru upp í kafla 6.1 í samantekt á eiginleikum lyfsins eru talin falla utan reglugerðar (EB) nr. 470/2009 þegar þau eru notuð eins og í þessu dýralyfi.
English: CEVA-Phylaxia Co. Ltd. 1107 Budapest Szállás u. 5.
Icelandic: 1107 Budapest Szállás u.
English: Store and use liquid nitrogen only in a dry and well-ventilated place.
Icelandic: Geymið og notið fljótandi köfnunarefni aðeins á þurrum og vel loftræstum stað.
English: Store and transport frozen in liquid nitrogen (-196 °C).
Icelandic: Geymið og flytjið í frysti í fljótandi köfnunarefni (-196 °C).
English: The vaccine strain was shown to be excreted by chickens and there was a slow spread to turkeys which was not detectable at 35 days but was detectable after 42 days of a contact study.
Icelandic: Sýnt var fram á að bóluefnisstofninn skilst út hjá kjúklingum og að um hægfara útbreiðslu til kalkúna var að ræða, sem ekki var greinanleg eftir 35 daga en var greinanleg við 42 daga í rannsókn á útbreiðslu.
English: Each dose of reconstituted vaccine (0.05 ml in-ovo or 0.2 ml subcutaneous) contains:
Icelandic: Hver skammtur af blönduðu bóluefni (0,05 ml til notkunar í egg eða 0,2 ml undir húð) inniheldur:
English: Repeat the operations in point 2-7 for the appropriate number of ampoules to be thawed.
Icelandic: Endurtaka skal liði 2-7 fyrir þann fjölda lykja sem á að þíða.
English: The speed of automatic injection is at least 2,500 eggs per hour, therefore solvent presentation of at least or more than 400 ml is recommended to prime and inject for longer than 10 minutes.
Icelandic: Hraði sjálfvirkrar inndælingar er að minnsta kosti 2.500 egg á klukkustund; þess vegna er mælt með leysi yfir 400 ml fyrir næmingu og inndælingu sem varir lengur en 10 mínútur.
English: {MM/YYYY}
Icelandic: <MM/ÁÁÁÁ}.
English: Read also the product information of Cevac Transmune before use.
Icelandic: Lesið einnig lyfjaupplýsingar fyrir Cevac Transmune fyrir notkun.
English: Transfer the suspension into the solvent bag.
Icelandic: Flytja skal lausnina í pokann með leysinum.