FrancophonIA/ELRC3.0 huggingface dataset:
English: Coxibs therefore display analgesic, anti-inflammatory and antipyretic properties.
Icelandic: Coxib hafa því verkjastillandi, bólgueyðandi og hitalækkandi áhrif.
English: As anaesthetic drugs may affect renal perfusion, the use of parenteral fluid therapy during surgery should be considered to decrease potential renal complications when using NSAIDs peri-operatively.
Icelandic: Þar sem að svæfingarlyf geta haft áhrif á gegnflæði í nýrum skal íhuga að gefa meðferð með vökva með inndælingu meðan á skurðaðgerð stendur til að minnka hættu á fylgikvillum í nýrum þegar bólgueyðandi gigtarlyf eru notuð.
English: Rarely, nervous system disorders have been reported in treated dogs.
Icelandic: Í mjög sjaldgæfum tilvikum hefur verið greint frá sjúkdómum í taugakerfi hjá hundum sem hafa verið meðhöndlaðir með lyfinu.
English: In in-vitro canine whole blood assays, firocoxib exhibits approximately 380-fold selectivity for COX-2 over COX-1.
Icelandic: Í in vitro heilblóðsrannsóknum hjá hundum hefur firocoxib um það bil 380 falt meiri sértækni fyrir COX-2 en COX-1.
English: The peak concentration (Cmax) is 0.52 (± 0.22) µg/ml (equivalent to approximately 1.5 µM), area under the curve (AUC 0-24) is 4.63 (±1.91) µg x hr/ml, and oral bioavailability is 36.9 (± 20.4) percent.
Icelandic: 4,63 (± 1,91) μg·x klst./ml og aðgengi eftir inntöku er 36,9 (± 20,4) hundraðshlutar.
English: Do not use in pregnant or lactating bitches.
Icelandic: Lyfið má ekki gefa hvolpafullum eða mjólkandi tíkum.
English: Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs (NSAIDs).
Icelandic: Lyfið má ekki nota samhliða barksterum eða öðrum bólgueyðandi gigtarlyfjum (NSAIDs).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle label
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á LITLUM
English: Osteoarthritis:
Icelandic: Verkunarmáti:
English: A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Icelandic: FRAMLEIÐANDI/FRAMLEIÐENDUR SEM ER(U) ÁBYRGUR/ÁBYRGIR FYRIR LOKASAMÞYKKT
English: Previcox 227 mg chewable tablets for dogs
Icelandic: Previcox 227 mg tuggutöflur handa hundum
English: Elimination is principally in the bile and gastrointestinal tract.
Icelandic: Brotthvarf verður einkum í galli og í meltingarvegi.
English: Previcox 57 mg chewable tablets for dogs Previcox 227 mg chewable tablets for dogs
Icelandic: 57 mg tuggutöflur handa hundum Previcox 227 mg tuggutöflur handa hundum
English: Use in very young animals, or animals with suspected or confirmed impairment of renal, cardiac or hepatic function may involve additional risk.
Icelandic: Vera má að aukin hætta sé fyrir hendi ef lyfið er notað handa mjög ungum dýrum eða dýrum sem grunur leikur á um eða þekkt er að eru með skerta nýrna-, hjarta- eða lifrarstarfsemi.
English: COX-2 is the isoform of the enzyme that has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever.
Icelandic: COX-2 er sú ísómynd ensímsins sem talið er að eigi stærstan þátt að máli við nýmyndun prostanóíðboða verkja, bólgu og hita.
English: Previcox must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Icelandic: Ekki má nota Previcox samhliða öðrum bólgueyðandi gigtarlyfjum (NSAID) eða sykursterum.
English: For the relief of pain and inflammation associated with osteoarthritis in dogs.
Icelandic: Við verkjum og bólgu í tengslum við slitgigt hjá hundum.
English: Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic products, non-steroids.
Icelandic: Bólgueyðandi lyf og gigtarlyf, nema barksterar.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton Box labelling
Icelandic: SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM Áletranir á öskju
English: Previcox 57 mg chewable tablets Firocoxib
Icelandic: 57 mg tuggutöflur Firocoxib
English: Renal and/or hepatic disorders have been reported in very rare cases in dogs administered the recommended treatment dose.
Icelandic: Örsjaldan hefur verið greint frá nýrna- og/eða lifrarsjúkdómum hjá hundum sem fengið hafa ráðlagðan meðferðarskammt.
English: For oral use as per table below.
Icelandic: Til inntöku í samræmi við töfluna hér á eftir.
English: Body weight (kg) Number of chewable tablets by size mg/kg range
Icelandic: Fjöldi tuggutaflna eftir styrkleika mg/kg bil
English: Previcox 57 mg chewable tablets for dogs
Icelandic: 57 mg tuggutöflur handa hundum
English: The treatment should be discontinued if any of these signs are observed: repeated diarrhoea, vomiting, faecal occult blood, sudden weight loss, anorexia, lethargy, degradation of renal or hepatic biochemistry parameters.
Icelandic: Endurtekinn niðurgangur, uppköst, blóð í saur, skyndilegt þyngdartap, lystarleysi, sinnuleysi, hnignun lífefnafræðilegra gilda nýrna- eða lifrarstarfsemi.
English: Gastrointestinal tract ulceration may be exacerbated by corticosteroids in animals given non-steroidal anti-inflammatory drugs.
Icelandic: Barksterar geta leitt til versnunar sára í meltingarvegi hjá dýrum sem fá bólgueyðandi gigtarlyf.
English: Following multiple oral administrations, the steady state is reached by the third daily dose.
Icelandic: Eftir endurtekna skammta með inntöku næst jafnvægi eftir þriðja dagsskammtinn.
English: Pain and inflammation associated with osteoarthritis.
Icelandic: Verkir og bólga í tengslum við slitgigt.
English: Concurrent administration of potentially nephrotoxic drugs should be avoided as there might be an increased risk for renal toxicity.
Icelandic: Forðast skal samhliða notkun lyfja sem geta hugsanlega haft eiturverkanir á nýru því fyrir hendi gæti verið aukin hætta á eiturverkunum á nýru.
English: Emesis and diarrhoea have occasionally been reported.
Icelandic: *Tíðni mögulegra aukaverkana er skilgreind samkvæmt eftirfarandi:
English: Avoid use in any dehydrated, hypovolaemic or hypotensive animals, as there is a potential risk of increased renal toxicity.
Icelandic: Forðast skal notkun lyfsins handa dýrum með vessaþurrð, blóðþurrð eða lágþrýsting því fyrir hendi er hugsanleg aukin hætta á eiturverkunum á nýru.
English: For the reduction of post-operative pain and inflammation, the animals can be dosed starting approximately 2 hours before surgery for up to 3 consecutive days as needed.
Icelandic: 2 klukkustundum fyrir skurðaðgerð og í allt að 3 daga í röð, eftir þörfum.
English: Peri-operative pain management.
Icelandic: Dýralyf - lyfseðilsskylt.
English: Avoid use in any dehydrated, hypovolaemic or hypotensive animals, as there is a risk of increased renal toxicity.
Icelandic: Forðast skal notkun lyfsins handa dýrum með vessaþurrð, blóðþurrð eða lágþrýsting vegna hættu á auknum eiturverkunum á nýru.
English: Shelf life of the veterinary medicinal product as packaged for sale: 4 years.
Icelandic: Geymsluþol dýralyfsins í söluumbúðum:
English: Mode of action:
Icelandic: ATCvet flokkur:
English: Concurrent administration of potentially nephrotoxic drugs should be avoided as there might be an increased risk of renal toxicity.
Icelandic: Forðast skal samhliða notkun lyfja sem hugsanlega geta valdið eiturverkunum á nýru.
English: A transient increase in body temperature, normally not exceeding an average of 1.1 °C, may occur within 24 hours after vaccination.
Icelandic: Tímabundin hækkun líkamshita, venjulega ekki meiri en 1,1°C að meðaltali, getur átt sér stað innan 24 klst.
English: MERIAL Animal Health Limited Biological Laboratory, Ash Road, Pirbright, Woking, Surrey GU24 0NQ United Kingdom
Icelandic: MERIAL Animal Health Limited Biological Laboratory, Ash Road, Pirbright, Woking, Surrey GU24 0NQ Bretland.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP.
Icelandic: Ekki skal nota dýralyfið eftir fyrningardagsetningu sem tilgreind er á öskjunnu á eftir EXP.
English: Laboratory of Lyon Porte des Alpes Rue de l'Aviation, 69800 Saint-Priest France
Icelandic: Laboratory of Lyon Porte des Alpes Rue de l'Aviation, 69800 Saint-Priest Frakkland.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal product on the whole or part of their territory if it is established that:
Icelandic: Samkvæmt ákvæðum 71. greinar í tilskipun Evrópuráðsins og þingsins 2001/82/EB með viðaukum getur aðildarríki, í samræmi við löggjöf sína, bannað framleiðslu, innflutning, vörslu, sölu, dreifingu og/eða notkun ónæmislyfja á öllu yfirráðasvæði sínu eða hluta þess ef sýnt er að:
English: Vaccination may be followed by a small local swelling at the injection site (at most 32 cm²) for a short period (at most 14 days).
Icelandic: Í kjölfar bólusetningar getur komið fram væg, staðbundin bólga á stungustað (allt að 32 cm²) í stuttan tíma (allt að 14 daga).
English: 50 doses (50 ml)
Icelandic: 50 skammtar (50 ml)
English: a) the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control and 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.
Icelandic: a) sé lyfið gefið dýrum muni það trufla framkvæmd innlendrar áætlunar er varðar greiningu, útrýmingu eða baráttu gegn dýrasjúkdómum eða geri erfitt um vik að staðfesta að smit sé ekki til staðar í lifandi dýrum eða matvælum eða öðrum afurðum úr dýrum sem hafa fengið lyfið.
English: The entire content of the bottle should be used immediately after broaching and during the same procedure.
Icelandic: Nota skal allt innihald flöskunnar strax eftir að hún er opnuð og í sömu bólusetningunni.
English: Each dose of 1 ml of vaccine contains:
Icelandic: Hver 1 ml skammtur af bóluefni inniheldur:
English: EXP {month/year}
Icelandic: FYRNINGARDAGSETNING EXP {mánuður/ár}
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.
Icelandic: Hjálparefnin (þ.m.t. ónæmisglæðar) sem talin eru upp í kafla 6.1 í samantekt á eiginleikum lyfsins eru leyfð innihaldsefni sem ekki þurfa gildi fyrir hámark lyfjaleifa samkvæmt töflu 1 í viðaukanum við reglugerð framkvæmdastjórnarinnar (ESB) nr. 37/2010.
English: Any person intending to import, sell, supply and/or use BTVPUR AlSap 8 must consult the relevant Member State's competent authority on the current vaccination policies prior to the import, sale, supply and/or use.
Icelandic: Sá sem ætlar að flytja inn, selja, dreifa og/eða nota BTVPUR AlSap 8 skal leita til viðkomandi yfirvalda til að fá upplýsingar um hvaða bólusetningarreglur gilda um dýr, áður en hafist er handa um innflutning, sölu, dreifingu og/eða notkun.
English: SPECIAL STORAGE CONDITIONS Store and transport refrigerated (2 °C-8 °C).
Icelandic: SÉRSTÖK GEYMSLUSKILYRÐI Geymið og flytjið í kæli (2°C - 8°C).
English: MARKETING AUTHORISATION NUMBER(S) EU/2/09/094/001
Icelandic: 16. MARKAÐSLEYFISNÚMER EU/2/09/094/001
English: No adverse reactions except those mentioned in section 4.6 were observed after the administration of a double- dose of the vaccine.
Icelandic: Ekki komu fram neinar aukaverkanir aðrar en þær sem taldar eru upp í kafla 4.6 eftir gjöf tvöfalds skammts af bóluefninu.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 10 doses (10 ml)
Icelandic: INNIHALD TILGREINT SEM ÞYNGD, RÚMMÁL EÐA FJÖLDI SKAMMTA 10 skammtar (10 ml)
English: BATCH NUMBER Lot{number}
Icelandic: LOTUNÚMER Lot {númer}
English: 1 bottle of 10 doses (1 x 10 ml) 1 bottle of 50 doses (1 x 50 ml) 10 bottles of 50 doses (10 x 50 ml) 1 bottle of 100 doses (1 x 100 ml) 10 bottles of 100 doses (10 x 100 ml)
Icelandic: 1 flaska með 10 skömmtum (1 x 10 ml) 1 flaska með 50 skömmtum (1 x 50 ml) 10 flöskur með 50 skömmtum (10 x 50 ml) 1 flaska með 100 skömmtum (1 x 100 ml) 10 flöskur með 100 skömmtum (10 x 100 ml)
English: The import, sale, supply and/or use of BTVPUR AlSap 8 is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
Icelandic: Innflutningur, sala, dreifing og/eða notkun BTVPUR AlSap 8 er eða getur verið óheimil í tilteknum aðildarríkjum, ýmist í ríkinu öllu eða hluta þess, samkvæmt ákvörðun viðkomandi yfirvalda varðandi heilbrigði dýra.
English: No adverse reactions except those mentioned in section ‘Adverse Reactions' were observed after the administration of a double-dose of vaccine.
Icelandic: Ekki komu fram neinar aukaverkanir aðrar en þær sem taldar eru upp í kaflanum „Aukaverkanir“ eftir gjöf tvöfalds skammts af bóluefninu.
English: Aluminium hydroxide Purified saponin Silicon antifoam Phosphate buffer Glycine buffer Water for injection
Icelandic: Hreinsað saponin Silicon froðueyðandi efni Fosfatbuffer
English: Bluetongue virus serotype 8 antigen ........................................................................... ≥ 2.1 log10 pixels* Aluminium hydroxide .................................................................................................................... 2.7 mg Saponin ........................................................................................................................................ 30 HU** (*) antigen content (VP2 protein) by immuno-assay (**) Haemolytic units
Icelandic: ........................................................... ≥ 2,1 log10 punktar* Álhýdroxíð ..................................................................................................................................... 2,7 mg Saponin ........................................................................................................................................ 30 HU** (*) Magn mótefnavaka (VP2 prótein) samkvæmt ónæmisprófi (**) Haemolytic units (blóðlýsueiningar)
English: PACKAGE SIZE 100 doses (100 ml)
Icelandic: PAKKNINGASTÆRÐ 100 skammtar (100 ml)
English: The duration of immunity for cattle and sheep is 1 year after the primary vaccination course.
Icelandic: Ending ónæmis hjá sauðfé og nautgripum er 1 ár í kjölfar grunnbólusetningar hjá.
English: Pharmacotherapeutic group: bluetongue virus vaccine, ATCvet code: QI04AA02 (sheep) and QI02AA08 (cattle).
Icelandic: QI04AA02 (sauðfé) og QI02AA08 (nautgripir).
English: * (below the level of detection by the validated RT-PCR method at 3.14 log10 RNA copies/ml, indicating no infectious virus transmission)
Icelandic: * (Undir greiningarmörkum viðurkenndu RT-PCR aðferðarinnar við 3,14 log10
English: Active immunisation of sheep and cattle to prevent viraemia* and to reduce clinical signs caused by Bluetongue virus serotype 8 (BTV 8).
Icelandic: Virk ónæmisaðgerð hjá sauðfé og nautgripum til að koma í veg fyrir veirusýkingu í blóði* og til að draga úr klínískum einkennum af völdum blátunguveiru af sermisgerð 8 (BTV 8).
English: *below the level of detection by the validated RT-PCR method at 3.14 log10 RNA copies/ml, indicating no infectious virus transmission
Icelandic: *Undir greiningarmörkum viðurkenndu RT-PCR aðferðarinnar við 3,14 log10
English: The safety and the efficacy of the vaccine has not been established in breeding males.
Icelandic: Ekki hefur verið sýnt fram á öryggi og verkun bóluefnisins hjá karldýrum sem notuð eru til undaneldis.
English: The vaccine contains inactivated Bluetongue virus serotype 8 with aluminium hydroxide and saponin adjuvants.
Icelandic: Bóluefnið inniheldur óvirkjaða blátunguveiru af sermisgerð 8 ásamt ónæmisglæðunum álhýdroxíði og saponini.
English: Type I glass bottle of 10 ml with butyl elastomere closure.
Icelandic: Flaska úr gleri af gerð I sem inniheldur 10 ml, með bútýl gúmmíloki.
English: Bluetongue virus serotype 8 antigen ........................................................................... ≥ 2.1 log10 pixels* (*) Antigen content (VP2 protein) by immuno-assay Adjuvants:
Icelandic: Mótefnavaki blátunguveiru (bluetongue virus), af sermisgerð 8 ............................. ≥ 2,1 log10 punktar* (*) Magn mótefnavaka (VP2 prótein) samkvæmt ónæmisprófi Ónæmisglæðar:
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each dose of 1 ml of vaccine contains: BTV8 antigen............................................... ≥ 2.1 log10 pixels* Aluminium hydroxide, Saponin, qs 1 dose (*) (*) see package leaflet
Icelandic: Mótefnavaka BTV 8 ......................... ≥ 2,1 log10 punktar* Álhýdroxíð, Saponin, magn í 1 skammti (*)
English: In cattle and sheep - 1st injection: from 1 month of age in naive animals (or from 2.5 months of age in young cattle and sheep born to immune animals).
Icelandic: - 1. inndæling: frá 1 mánaða aldri handa dýrum sem eru að fá bóluefnið í fyrsta skipti (eða frá
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml of vaccine contains:
Icelandic: VIRK(T) INNIHALDSEFNI OG ÖNNUR INNIHALDSEFNI Hver 1 ml skammtur af bóluefni inniheldur:
English: Shelf life of the veterinary medicinal product as package for sale (50-ml and 100-ml bottles): 2 years.
Icelandic: Geymsluþol dýralyfsins í söluumbúðum (50 ml og 100 ml flöskur):
English: In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/ or national Competent Authorities on the current vaccination policies against Bluetongue virus (BTV).
Icelandic: Hjá þessum dýrum má eingöngu nota bóluefnið að undangengnu ávinnings-/áhættumati dýralæknis og/eða viðkomandi yfirvalda í hverju landi fyrir sig m.t.t. gildandi reglna um bólusetningu gegn blátunguveiru.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each dose of 1 ml of vaccine contains Bluetongue virus serotype 8 antigen ................. ≥ 2.1 log10 pixels
Icelandic: VIRK(T) INNIHALDSEFNI OG ÖNNUR INNIHALDSEFNI Hver 1 ml skammtur af bóluefni inniheldur mótefnavaka blátunguveiru, sermigerð 8 ...................................................................
English: Shelf life of the veterinary medicinal product as package for sale (10-ml bottle): 18 months.
Icelandic: Geymsluþol dýralyfsins í söluumbúðum (10 ml flaska):
English: Shelf life after first opening the immediate packaging: immediately after broaching.
Icelandic: Geymsluþol eftir að innri umbúðir hafa verið rofnar: nota skal lyfið strax.
English: It induces an active and specific immunity against bluetongue virus serotype 8 in the vaccinated animal.
Icelandic: Það veldur virku og sértæku ónæmi gegn blátunguveiru af sermisgerð 8 hjá bólusettum dýrum.
English: Box of 10 bottles of 50 doses (10 x 50 ml).
Icelandic: Askja með 10 flöskum með 50 skömmtum (10 x 50 ml)
English: Box of 1 bottle of 10 ml Box of 1 bottle of 50 ml, Box of 10 bottles of 50 ml, Box of 1 bottle of 100 ml, Box of 10 bottles of 100 ml
Icelandic: Askja með 1 flösku með 50 ml Askja með 10 flöskum með 50 ml Askja með 1 flösku með 100 ml
English: Polypropylene bottle of 50 or 100 ml with butyl elastomere closure.
Icelandic: Pólýprópýlen flaska með bútýl gúmmíloki sem inniheldur 50 eða 100 ml.
English: Box of 10 bottles of 100 doses (10 x 100 ml).
Icelandic: Askja með 10 flöskum með 100 skömmtum (10 x 100 ml)
English: Box of 1 bottle of 50 doses (1 x 50 ml).
Icelandic: Askja með 1 flösku með 50 skömmtum (1 x 50 ml)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle of 100 ml
Icelandic: INNRI UMBÚÐUM Flaska með 100 ml
English: TARGET SPECIES Sheep and cattle
Icelandic: DÝRATEGUND(IR) Sauðfé og nautgripir
English: 4.2 Indications for use, specifying the target species Active immunisation of sheep and cattle to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotype 8.
Icelandic: Virk ónæmisaðgerð hjá sauðfé og nautgripum til að koma í veg fyrir veirusýkingu í blóði* og til að draga úr klínískum einkennum af völdum blátunguveiru af sermisgerð 8.
English: Box of 1 bottle of 100 doses (1 x 100 ml).
Icelandic: Askja með 1 flösku með 100 skömmtum (1 x 100 ml)
English: Box of 1 bottle of 10 doses (1 x 10 ml).
Icelandic: Askja með 1 flösku með 10 skömmtum (1 x 10 ml)
English: 4.11 Withdrawal period Zero days.
Icelandic: 4.11 Biðtími fyrir afurðanýtingu
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle of 10 and 50 ml
Icelandic: INNRI UMBÚÐUM Flaska með 10 og 50 ml
English: PACKAGE LEAFLET FOR: BTVPUR AlSap 8 suspension for injection
Icelandic: FYLGISEÐILL FYRIR BTVPUR AlSap 8 stungulyf, dreifu
English: NAME OF THE VETERINARY MEDICINAL PRODUCT BTVPUR AlSap 8 suspension for injection
Icelandic: HEITI DÝRALYFS BTVPUR AlSap 8 stungulyf, dreifa
English: Can be used during pregnancy and lactation in cows.
Icelandic: Nota má dýralyfið á meðgöngu og við mjólkurgjöf hjá kúm.
English: Sheep and cattle
Icelandic: Meðganga og mjólkurgjöf:
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) BTV 8 antigen ...................................................................................................... ≥ 2.1 log10 pixels/dose
Icelandic: MAGN VIRKS INNIHALDSEFNIS/VIRKRA INNIHALDSEFNA Mótefnavaki BTV 8.....................................................................................
English: PHARMACEUTICAL FORM Suspension for injection
Icelandic: Vatn fyrir stungulyf
English: Read package leaflet before use.
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á LITLUM
English: Fertility:
Icelandic: Dýralyf.
English: Aluminium hydroxide .................................................................................................................... 2.7 mg Saponin ........................................................................................................................................ 30 HU** (**) Haemolytic units
Icelandic: Álhýdroxíð ..................................................................................................................................... 2,7 mg Saponin .................................
English: These patients should be followed closely.
Icelandic: Fylgjast þarf vel með þessum sjúklingum.
English: Your child's doctor will decide the right dose based on your child's weight.
Icelandic: Læknir barnsins þíns mun ákvarða rétta skammtinn miðað við þyngd barnsins.
English: Results beyond 48 weeks of treatment
Icelandic: Niðurstöður eftir meira en 48 vikna meðferð
English: The randomization was stratified by age group (2 to 6 years; >6 to 12 years; and >12 to <18 years).
Icelandic: Slembiröðunin var lagskipt eftir aldri (2 til 6 ára; >6 til 12 ára og >12 til<18 ára).
English: if you are also infected with HIV (human immunodeficiency virus) be sure to tell your doctor.
Icelandic: ● ef þú ert einnig með HIV smit (HIV: human immunodeficiency virus) þarftu að láta lækninn vita.
English: When your treatment with Entecavir Mylan is stopped, your doctor will continue to monitor you and take blood tests for several months.
Icelandic: Þegar meðferð með Entecavir Mylan er hætt mun læknirinn fylgjast með þér og taka blóðsýni í nokkra mánuði
English: 117 Allée des Parcs 69800 Saint Priest France
Icelandic: Allée des Parcs 69800 Saint Priest Frakkland
English: Normalization of:f
Icelandic: Eðlileg gildi:f
English: Children and adolescents (from 2 to less than 18 years of age) can take Entecavir Mylan with or without food.
Icelandic: Börn og unglingar (frá tveggja ára til yngri en 18 ára) mega taka Entecavir Mylan með mat eða án.
English: Rare (at least 1 in 10,000 patients): severe allergic reaction.
Icelandic: Mjög sjaldgæfar (a.m.k. 1 af hverjum 10.000 sjúklingum): alvarleg ofnæmisviðbrögð.
English: Some patients must take Entecavir Mylan on an empty stomach (see Entecavir Mylan with food and drink in Section 2).
Icelandic: Sumir sjúklingar verða að taka Entecavir Mylan á fastandi maga (sjá Notkun Entecavir Mylan með mat eða drykk í kafla 2).
English: If you were switched over to Entecavir Mylan because the treatment with lamivudine was not successful, you should take Entecavir Mylan on an empty stomach once daily.
Icelandic: Ef breytt hefur verið í meðferð með Entecavir Mylan vegna þess að meðferð með lamivúdíni bar ekki árangur, skaltu taka Entecavir Mylan á fastandi maga einu sinni á dag.
English: ATC code: J05AF10
Icelandic: J05AF10.
English: In most cases you may take Entecavir Mylan with or without food.
Icelandic: Yfirleitt má taka Entecavir Mylan hvort með mat eða án.