FrancophonIA/ELRC3.0 huggingface dataset:
English: Week 26 Week 52 p value for Standard Dose versus Low Dose comparison 2 Immunosuppressant therapy could only be discontinued at or after week 26 at the investigator's discretion if the subject met the clinical response criterion 3 Defined as a closure of all fistulas that were draining at Baseline for at least 2 consecutive post-Baseline visits
Icelandic: 26 samkvæmt ákvörðun rannsakanda hafi sjúklingur náð viðmiðum klínískrar svörunar 3 skilgreint sem lokun allra fistla sem láku við upphafsgildi, í a.m.k.
English: This may mean there is an infection and therefore you should contact your doctor.
Icelandic: og því skal hafa samband við lækninn.
English: Among patients who had failed prior anti-TNF treatment, week 52 remission was achieved by 3 % on placebo and 10 % on adalimumab.
Icelandic: 52 hjá 3 % sjúklinga sem fengu lyfleysu og 10 % sjúklinga sem fengu adalimumab.
English: For single use only
Icelandic: Aðeins einnota
English: The decision to stop using Imraldi should be discussed with your doctor.
Icelandic: Ræða skal við lækninn um hvort hætta eigi að nota Imraldi.
English: Pen disposal
Icelandic: Förgun sprautu
English: Table 16 ACR Response in Placebo-Controlled Psoriatic Arthritis Studies (Percent of Patients)
Icelandic: Tafla 16 ACR svörun í lyfleysustýrðum samanburðarrannsóknum hjá sjúklingum með sóraliðbólgu (Hlutfall sjúklinga)
English: Dosing Regimen
Icelandic: 6) Förgun
English: If you use more Imraldi than you should
Icelandic: Ef notaður er stærri skammtur
English: Children and adolescents from 6 to 17 years of age weighing 40 kg or more The usual dose regimen is 80 mg (as two 40 mg injections in one day) initially followed by 40 mg two weeks later.
Icelandic: Börn og unglingar á aldrinum 6-17 ára sem eru minna en 40 kg að þyngd Venjulegur skammtur er 40 mg í upphafi sem fylgt er eftir með 20 mg tveimur vikum síðar.
English: Subjects had to have failed conventional therapy (including a corticosteroid and/or an immunomodulator) for CD.
Icelandic: Imraldi stendur skal haga annarri samhliða meðferð (t.d. barksterar og/eða ónæmistemprandi lyf) þannig að hún skili sem mestum árangri.
English: Injection site care
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á
English: HS study I
Icelandic: HS rannsókn
English: Table 6 Undesirable Effects
Icelandic: Tafla 6 Aukaverkanir
English: • paediatric uveitis.
Icelandic: • skert sáragræðsla.
English: • intestinal perforation;
Icelandic: • vélindabakflæði
English: Infection
Icelandic: Líffæri
English: Children, adolescents and adults with enthesitis-related arthritis Children and adolescents from 6 years of age weighing 15 kg to less than 30 kg The recommended dose of Imraldi is 20 mg every other week.
Icelandic: 30 kg eða þyngri Ráðlagður skammtur af Imraldi er 40 mg aðra hverja viku Börn, unglingar og fullorðnir með festumeinstengda liðagigt Börn og unglingar frá 6 ára aldri sem eru 15 kg til minna en 30 kg að þyngd Ráðlagður skammtur af Imraldi er 20 mg aðra hverja viku.
English: B. PACKAGE LEAFLET
Icelandic: Ein pakkning innheldur
English: Adverse Reaction alopecia1), pruritus
Icelandic: Sarklíki1), æðabólga
English: • intestinal infections (including gastroenteritis);
Icelandic: • sýkingar í taugakerfi (þ.m.t. veirumengisbólga)
English: • migraine;
Icelandic: • hryggikt,
English: 6 months 12 months a RA study I at 24 weeks, RA study II at 26 weeks, and RA study III at 24 and 52 weeks b 40 mg adalimumab administered every other week c MTX = methotrexate
Icelandic: I í 24. viku, RA rannsókn II í 26. viku, og RA rannsókn III í 24. og 52. viku
English: HRa
Icelandic: Hópur
English: Table 1 Imraldi Dose for Patients with Polyarticular Juvenile Idiopathic Arthritis Patient Weight
Icelandic: Tafla 1 Imraldi skammtar fyrir börn með sjálfvakta fjölliðagigt
English: Continued therapy should be carefully considered in a subject not responding by week 12.
Icelandic: Íhuga skal vandlega hvort halda eigi meðferð áfram, hafi sjúklingur ekki svarað meðferð eftir 12 vikur.
English: Confirm completion & dispose
Icelandic: VIÐAUKI III ÁLETRANIR OG FYLGISEÐILL
English: Low dose
Icelandic: UM AÐ LYFIÐ
English: Rheumatoid arthritis
Icelandic: endurvirkjun lifrarbólgu
English: PsA study I
Icelandic: PsA rannsókn
English: Holbaek DK-4300
Icelandic: DK-4300
English: Sanofi-Aventis, s.r.o.
Icelandic: Tékkland Sanofi-Aventis, s.r.o.
English: Amsterdam GK - 1081 The Netherlands
Icelandic: Amsterdam GK - 1081
English: Piso 0 2740-268 Porto Salvo
Icelandic: Piso 0 2740-268
English: Finland Alternova A/S Lodshusvej 11
Icelandic: Finnland Alternova A/S Lodshusvej 11
English: Alet Pharmaceuticals M. Alexander 121, Agia Varvara, 12351 Greece
Icelandic: Alet Pharmaceuticals M. Alexander 121, Agia Varvara, 12351
English: Ethnikis Antistaseos & Trifyllias,
Icelandic: Grikkland Viofar EPE Ethnikis Antistaseos & Trifyllias,
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States
Icelandic: I Listi yfir heiti, lyfjaform, styrkleika lyfjanna, íkomuleiðir og markaðsleyfishafa í aðildarlöndunum
English: Uni-Pharma Kleon Tseitis Pharmaceutical Laboratories
Icelandic: Grikkland Uni-Pharma Kleon Tseitis Pharmaceutical
English: Laboratórios Normon, S.A. Rua Armando Villar, Lote 42 1º Dto.
Icelandic: Rua Armando Villar, Lote 42 1º Dto.
English: Tatoiou Street Nea Erythrea 14671 Greece
Icelandic: Street Nea Erythrea 14671 Greece
English: Pharmachemie B.V. Haarlem - 2031 GA The Netherlands
Icelandic: Holland Pharmachemie B.V. Haarlem - 2031
English: Sanofi-Aventis SPA Viale Luigi Bodio, 37/B 20158 Milano Italy sodium ferric gluconate complex
Icelandic: Sanofi-Aventis SPA Viale Luigi Bodio, 37/B 20158 Milano Italy sódíum járnbundin glókónat-samstæða
English: Verisfield (UK) Ltd, U.K. 41 Chalton street London, NW1 1JD United Kingdom
Icelandic: Grikkland Verisfield (UK) Ltd, U.K. 41 Chalton street
English: PHARMABIDE LTD 20, Lakonias str, 15234 Halandri Athens - Greece
Icelandic: Tékkland PHARMABIDE LTD 20, Lakonias str, 15234 Halandri
English: VIFOR France SA 123 Rue Jules Guesde 92200 Neuilly-sur-Seine France
Icelandic: Pólland VIFOR France SA 123 Rue Jules Guesde 92200 Neuilly-sur-Seine France
English: Aftokratoros Nikolaou 2 Athens 17671
Icelandic: 2 Athens 17671
English: 110, Esplanade du Général de Gaulle
Icelandic: Frakkland TEVA SANTE 110, Esplanade du Général de Gaulle 92931
English: Sweden Orion Corporation, Orionintie 1,
Icelandic: Svíþjóð Orion Corporation, Orionintie 1,
English: 21st km National Highway Athens-Lamia, 14565 Greece
Icelandic: Demo ABEE 21st km National Highway Athens-Lamia, 14565 Greece
English: Iroprem 50 mg/ml raztopina za iniciranje ali infundiranje
Icelandic: Karboxýmaltsykur Iroprem 50 mg/ml raztopina za iniciranje ali infundiranje
English: Germany Sanofi-Aventis Deutschland GmbH Brüningstrasse 50, D-65926 Frankfurt am Main Germany sodium ferric gluconate complex
Icelandic: Þýskaland Sanofi-Aventis Deutschland GmbH Brüningstrasse 50, D-65926
English: Denmark Orion Corporation, Orionintie 1,
Icelandic: Danmörk Orion Corporation, Orionintie 1,
English: Czech Republic sodium ferric gluconate complex
Icelandic: Czech Republic sódíum járnbundin glókónat-samstæða
English: Rafarm AEBE Korinthou 12, N. Psychiko, 15451 Greece
Icelandic: N. Psychiko, 15451
English: Lek Pharmaceuticals d.d.
Icelandic: Eistland Lek Pharmaceuticals d.d. Verovškova 57
English: 14KM National Highway Athens-Lamia Kifissia 14564
Icelandic: 14KM National Highway Athens-Lamia
English: Vianex S.A.
Icelandic: Grikkland Vianex S.A. Tatoiou
English: Germany Medice Arzneimittel Pütter GmbH & Co KG
Icelandic: Þýskaland Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37
English: Specifar AEBE 28th October Street 1 Agia Barbara 12351 Greece
Icelandic: 1 Agia Barbara 12351
English: Pharmaki Generics Ltd 5 Bourlet Close W1W 7BL London United Kingdom
Icelandic: Frakkland Pharmaki Generics Ltd 5 Bourlet
English: Iron (III) hydroxide dextran
Icelandic: Járnblandað (III) hýdroxíð-dextran
English: Solution for injection Solution for infusion
Icelandic: Injektionslösung und Infusionslösung
English: Intermed ABEE Kalyftaki 27 Athens 14564 Greece
Icelandic: Intermed ABEE Kalyftaki 27
English: COSMOFER SOLUTION FOR INJECTION OR INFUSION 50MG IRON/ML
Icelandic: COSMOFER SOLUTION FOR INJECTION OR INFUSION 50MG
English: Egelenburg 2
Icelandic: Holland Pharmamatch B.V. Egelenburg 2
English: Solution for infusion
Icelandic: Lösung zur Injektion/Infusion
English: HIERRO SACAROSA NORMON 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION
Icelandic: HIERRO SACAROSA NORMON 20 mg/ml SOLUCION
English: FERINJECT SOLUTION FOR INJECTION OR INFUSION 50MG IRON/ML
Icelandic: FERINJECT SOLUTION FOR INJECTION OR INFUSION 50MG
English: Lithuania VIFOR France SA 7-13 Boulevard Paul Emile Victor
Icelandic: Litháen VIFOR France SA 7-13
English: Iron (III) hydroxide dextran complex
Icelandic: Járnbundið (III) hýdroxíð-dextransamstæða
English: Target Pharma Ltd Menandrou 54 Athens 10431
Icelandic: Athens 10431
English: Lithuania Pharmacosmos A/S Roervangsvej 30
Icelandic: Litháen Pharmacosmos A/S Roervangsvej 30
English: Solution for perfusion
Icelandic: SOLUCIÓN INYECTABLE O PARA PERFUSIÓN
English: Concentrate for solution for infusion/solution for injection
Icelandic: Injektionslösung/ Konzentrat zur Herstellung einer Infusionslösung
English: Venofer 20 mg FR / ml Injektionslösung
Icelandic: Venofer 20 mg FR / ml
English: Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl Austria
Icelandic: Pólland Sandoz GmbH Biochemiestrasse 10
English: Finland Pharmacosmos A/S Roervangsvej 30
Icelandic: Finnland Pharmacosmos A/S Roervangsvej 30
English: VIFOR France SA 7-13 Boulevard Paul Emile Victor
Icelandic: Boulevard Paul Emile Victor
English: COSMOFER 50 mg/ml SOLUCION PARA PERFUSION E INYECCION
Icelandic: COSMOFER 50 mg/ml SOLUCION PARA PERFUSION
English: Genericos Espanoles Laboratorio S.A.Cólquide, 6 - Portal 2, 1 Oficina F.Las Rozas 28230 MADRID Spain
Icelandic: F.Las Rozas 28230 MADRID Spain
English: Denmark Pharmacosmos A/S Roervangsvej 30
Icelandic: Danmörk Pharmacosmos A/S Roervangsvej 30
English: Finland VIFOR France SA 7-13 Boulevard Paul Emile Victor
Icelandic: Finnland VIFOR France SA 7-13
English: Finland Fresenius Medical Care Nephrologica Deutschland GmbH
Icelandic: Finnland Fresenius Medical Care Nephrologica Deutschland GmbH
English: Lithuania Fresenius Medical Care Nephrologica Deutschland GmbH
Icelandic: Litháen Fresenius Medical Care Nephrologica Deutschland GmbH
English: Romania Pharmacosmos A/S Roervangsvej 30
Icelandic: Rúmenía Pharmacosmos A/S Roervangsvej 30
English: Poland
Icelandic: Belgía
English: Romania VIFOR France SA 7-13 Boulevard Paul Emile Victor
Icelandic: Rúmenía VIFOR France SA 7-13
English: Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark
Icelandic: Pharmacosmos A/S Roervangsvej 30 Holbaek
English: Denmark VIFOR France SA 7-13 Boulevard Paul Emile Victor
Icelandic: Danmörk VIFOR France SA 7-13
English: Germany Pharmacosmos A/S Roervangsvej 30
Icelandic: Frakkland Pharmacosmos A/S Roervangsvej 30
English: Denmark Fresenius Medical Care Nephrologica Deutschland GmbH
Icelandic: Holland Fresenius Medical Care Nephrologica Deutschland GmbH
English: Iceland VIFOR France SA 7-13 Boulevard Paul Emile Victor
Icelandic: Eistland VIFOR France SA 7-13
English: Iceland Pharmacosmos A/S Roervangsvej 30
Icelandic: Eistland Pharmacosmos A/S Roervangsvej 30
English: Germany VIFOR France SA 7-13 Boulevard Paul Emile Victor
Icelandic: Þýskaland VIFOR France SA 7-13
English: Sweden Fresenius Medical Care Nephrologica Deutschland GmbH
Icelandic: Svíþjóð Fresenius Medical Care Nephrologica Deutschland GmbH
English: Germany Fresenius Medical Care Nephrologica Deutschland GmbH
Icelandic: Þýskaland Fresenius Medical Care Nephrologica Deutschland GmbH
English: Sweden VIFOR France SA 7-13 Boulevard Paul Emile Victor
Icelandic: Holland VIFOR France SA 7-13
English: Belgium Pharmacosmos A/S Roervangsvej 30
Icelandic: Bretland Pharmacosmos A/S Roervangsvej 30
English: Demo ABEE
Icelandic: HELP ABEE Valaoritou 10
English: 16 mg Implant
Icelandic: 16 mg Vefjalyf
English: Subcutaneous use vial (glass)
Icelandic: Til notkunar undir húð hettuglas (gler)
English: See sections 4.3, 4.4 and 4.8.
Icelandic: Sjá kafla 4.3, 4.4 og 4.8.
English: These are not, however, recommendations for storage.
Icelandic: Þetta eru þó ekki ráðleggingar varðandi geymslu.
English: Common (≥1/100 to, <1/10)
Icelandic: Algengt (≥1/100 til, <1/10)
English: Therefore, hypersensitivity reactions may occur (see sections 2 and 4.8).
Icelandic: Þess vegna geta komið fram ofnæmisviðbrögð (sjá kafla 2 og 4.8).
English: - if you or your child has a severe illness with fever
Icelandic: ef þú eða barnið þitt eru með alvarleg veikindi ásamt hita.
English: The following information is intended for medical or health care professionals only:
Icelandic: Eftirfarandi upplýsingar eru einungis ætlaðar heilbrigðisstarfsmönnum:
English: Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Icelandic: Eins og við á um öll lyf getur þetta bóluefni valdið aukaverkunum en það gerist þó ekki hjá öllum.
English: Latex rubber may cause severe allergic reactions.
Icelandic: Latex-gúmmí getur valdið alvarlegum ofnæmisviðbrögðum.
English: Animal reproduction studies have not been conducted.
Icelandic: Ekki hafa verið framkvæmdar neinar frjósemisrannsóknir á dýrum.
English: Apnoea in very premature infants (born ≤ 28 weeks of gestation) (see section 4.4).
Icelandic: Öndunarstöðvun hjá miklum fyrirburum (fæddir ≤ 28 vikna meðgöngu) (sjá kafla 4.4).
English: Pennsylvania 19486
Icelandic: Pike West POINT, Pennsylvania 19486
English: Individuals less than 16 years of age:
Icelandic: Skammtar Einstaklingar 16 ára og eldri:
English: Your doctor or nurse will decide when to give the missed dose.
Icelandic: Læknirinn eða hjúkrunarfræðingurinn mun ákveða hvenær á að gefa skammtinn sem gleymdist.
English: Two primary immunisation schedules can be recommended:
Icelandic: Hægt er að mæla með tveimur upphafsbólusetningaráætlunum:
English: When persons who do not respond to the primary vaccine series are revaccinated, 15-25 % produce an adequate antibody response after one additional dose and 30-50 % after three additional doses.
Icelandic: Þegar einstaklingar sem ekki hafa sýnt nein viðbrögð við fyrstu ónæmisaðgerðinni eru endurbólusettir, sýna 15-25 % nægilega mótefnasvörun við einn viðbótarskammt og 30-50 % eftir þrjá viðbótarskammta.
English: Consideration should be given to serological testing of those subjects who may be at risk of not achieving seroprotection following a complete course of HBVAXPRO.
Icelandic: Íhuga ætti að framkvæma sermipróf á þeim viðföngum sem hugsanlega eiga á hættu að njóta ekki mótefnaverndar eftir að hafa fengið fulla meðferð með HBVAXPRO.
English: • Asthma-like symptoms
Icelandic: • astma-lík einkenni
English: Hepatitis B vaccine has been recognized as the first anti-cancer vaccine because it can prevent primary liver cancer.
Icelandic: B bóluefni hefur verið viðurkennt sem fyrsta bóluefnið gegn krabbameini þar sem það getur komið í veg fyrir krabbamein með uppruna í lifur.
English: As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Icelandic: Þar sem ávinningur af bólusetningu er mikill hjá þessum hópi ungbarna, skal ekki hætta við bólusetningu eða fresta henni.
English: 2031 BN Haarlem The Netherlands
Icelandic: 2031 BN Haarlem Holland.
English: This leaflet was last approved in {MM/YYYY}
Icelandic: Þessi fylgiseðill var síðast uppfærður{MM/ÁÁÁÁ}
English: - if you have a severe illness with fever
Icelandic: ef þú ert með alvarleg veikindi ásamt hita.
English: The concomitant administration of pneumococcal conjugate vaccine (PREVENAR) given with hepatitis B vaccine using the 0, 1 and 6 and 0, 1, 2 and 12 month schedules has not been sufficiently studied.
Icelandic: Samhliða lyfjagjöf samtengds bóluefnis gegn pneumókokkasýkingum (PREVENAR) og bóluefnis gegn lifrarbólgu B, samkvæmt 0, 1 og 6 og 0, 1, 2 og 12 mánaða áætlun, hefur ekki verið nægilega rannsökuð.
English: Do not use this vaccine after the expiry date which is stated on the label.
Icelandic: Ekki skal nota bóluefnið eftir fyrningardagsetningu sem tilgreind er á merkimiðanum.
English: * produced in Saccharomyces cerevisiae (strain 2150-2-3) yeast by recombinant DNA technology.
Icelandic: * framleiddur í Saccharomyces cerevisiae (stofn 2150-2-3) með raðbrigða DNA tækni.
English: Cumulative multiple excursions between 0°C and 2°C are also permitted as long as the total time between 0°C and 2°C does not exceed 72 hours.
Icelandic: Einnig eru samanlögð frávik á bilinu 0°C til 2°C leyfileg svo framarlega sem heildartími á bilinu 0°C til 2°C sé ekki lengri en 72 klst.
English: In babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination.
Icelandic: Í fyrirburum fæddum mikið fyrir tímann (28 vikur meðganga eða fyrr) getur bilið milli andardrátta varað lengur en venjulega, í 2-3 daga eftir bólusetningu.
English: Additional doses may need to be considered for persons who do not respond or have a sub-optimal response to a course of vaccinations.
Icelandic: Íhuga þarf mögulega aukaskammta fyrir þá einstaklinga sem ekki svara eða veita lélega svörun við bólusetningarmeðferð.
English: Precautions to be taken before handling or administering the product: see section 6.6.
Icelandic: Varúðarráðstafanir sem þarf að gera áður en lyfið er meðhöndlað eða gefið, sjá kafla 6.6.
English: In two infant trials using different dosing schedules and concomitant vaccines, the proportion of infants with protective levels of antibodies were 97.5 % and 97.2 % with geometric mean titres of 214 and 297 IU/l, respectively.
Icelandic: Í tveimur rannsóknum á ungbörnum þar sem notaðar voru mismunandi skammtaáætlanir og samhliða lyfjagjöf voru hlutföll ungbarna sem sýndu fram á mótefnamyndun sem veitti sjúkdómsvörn 97,5% og 97,2%, og meðalmótefnatítrar voru 214 og 297 AE/l, í hvorri rannsókn fyrir sig.
English: In two trials conducted in older adolescents and adults, 95.6-97.5 % of vaccinees developed a protective level of antibodies, with geometric mean titres in these trials ranging from 535 - 793 IU/l.
Icelandic: Í tveimur rannsóknum á eldri unglingum og fullorðnum, þróuðu 95,6-97,5 % bólusettra mótefnavörn og voru meðalmótefnatítrar í þessum rannsóknum á bilinu 535793 AE/l.
English: HBVAXPRO should be administered as soon as possible after being removed from refrigeration.
Icelandic: HBVAXPRO á að gefa eins og fljótt og hægt er eftir að það hefur verið tekið úr kæli.
English: Adsorbants are substances included in certain vaccines to accelerate, improve and/or prolong the protective effects of the vaccine.
Icelandic: Sum bóluefni innihalda aðsogsefni til að hraða, bæta og/eða lengja verndandi áhrif bóluefnissins.
English: Merck Sharp and Dohme, B.V. Waarderweg, 39
Icelandic: Merck Sharp & Dohme, B.V. Waarderweg, 39
English: The vaccine should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Icelandic: Einungis skal nota bóluefnið meðan á meðgöngu stendur, ef mögulegur ávinningur réttlætir hugsanlega áhættu fyrir fóstrið.
English: Hold the syringe barrel and attach the needle by twisting in clockwise direction, until the needle fits securely on the syringe.
Icelandic: Haldið um bol sprautunnar og festið nálina með því að snúa henni réttsælis þar til hún er tryggilega föst við sprautuna.
English: - Hepatitis B immunoglobulin should be given as soon as possible after exposure (within 24 hours).
Icelandic: B immunóglóbulín eins fljótt og hægt er eftir útsetningu (innan 24 klst.).
English: 1 single dose 0.5 ml pre-filled syringe without needle 10 single dose 0.5 ml pre-filled syringes without needle 20 single dose 0.5 ml pre-filled syringes without needle 50 single dose 0.5 ml pre-filled syringes without needle 1 single dose 0.5 ml pre-filled syringe with 1 separate needle 10 single dose 0.5 ml pre-filled syringes with 1 separate needle (for each syringe) 1 single dose 0.5 ml pre-filled syringe with 2 separate needles 10 single dose 0.5 ml pre-filled syringes with 2 separate needles (for each syringe) 20 single dose 0.5 ml pre-filled syringes with 2 separate needles (for each syringe) 50 single dose 0.5 ml pre-filled syringes with 2 separate needles (for each syringe)
Icelandic: Stakskammta, 0,5 ml áfyllt sprauta án nálar 10 stakskammta, 0,5 ml áfylltar sprautur án nála 20 stakskammta, 0,5 ml áfylltar sprautur án nála 50 stakskammta, 0,5 ml áfylltar sprautur án nála Stakskammta, 0,5 ml áfyllt sprauta með 1 lausri nál 10 stakskammta, 0,5 ml áfylltar sprautur með 1 lausri nál (fyrir hverja sprautu) Stakskammta, 0,5 ml áfyllt sprauta með 2 lausum nálum 10 stakskammta, 0,5 ml áfylltar sprautur með 2 lausum nálum (fyrir hverja sprautu) 20 stakskammta, 0,5 ml áfylltar sprautur með 2 lausum nálum (fyrir hverja sprautu) 50 stakskammta, 0,5 ml áfylltar sprautur með 2 lausum nálum (fyrir hverja sprautu)
English: The recommended dose for each injection (1 ml) is 10 micrograms for individuals 16 years of age or more.
Icelandic: Ráðlagður skammtur er 10 míkrógrömm (1 ml) í hverri inndælingu fyrir einstaklinga 16 ára og eldri.
English: The need for a booster dose in healthy individuals who have received a full primary vaccination course has not been established.
Icelandic: Ekki hefur verið lagt mat á þörf fyrir örvunarskammt hjá heilbrigðum einstaklingum sem fengið hafa fulla upphafs bólusetningu.
English: The recommended dose for each injection (0.5 ml) is 5 micrograms for individuals from birth through 15 years of age.
Icelandic: Ráðlagður skammtur er 5 míkrógrömm (0,5 ml) í hverri inndælingu fyrir einstaklinga frá fæðingu að 15 ára aldri.
English: This vaccine should never be given into a blood vessel.
Icelandic: Aldrei má gefa bóluefnið í æð.
English: If these conditions exist, the product should not be administered.
Icelandic: Ef slíkt er til staðar, má ekki gefa lyfið.
English: Dizziness and Fainting
Icelandic: Blóð og eitlar
English: No studies on the effects on the ability to drive and use machines have been performed.
Icelandic: Engar rannsóknir hafa verið gerðar á áhrifum lyfsins á hæfni til að stjórna bifreið eða vélum.
English: year later (0, 1, 2, 12 months).
Icelandic: 0, 1, 2, 12 mánuðir:
English: HBVAXPRO can be administered provided total (cumulative multiple excursion) time out of refrigeration (at temperatures between 8°C and 25°C) does not exceed 72 hours.
Icelandic: HBVAXPRO má gefa ef heildartími (samanlögð frávik) sem lyfið er utan kælis (við 8°C - 25°C) er ekki lengri en 72 klst.
English: The vaccine will not prevent infection caused by other agents such as hepatitis A, hepatitis C and hepatitis E and other pathogens known to infect the liver.
Icelandic: Bóluefnið kemur ekki í veg fyrir sýkingu af öðrum lifrarbólguveirum t.d. lifrarbólgu A, lifrarbólgu C og lifrarbólgu E og öðrum sjúkdómsvöldum sem geta sýkt lifrina.
English: MSD VACCINS 162 avenue Jean Jaurès 69007 Lyon France
Icelandic: MSD VACCINS 162 avenue Jean Jaurès 69007 Lyon Frakkland
English: The vaccine induces specific humoral antibodies against hepatitis B virus surface antigen (anti-HBsAg).
Icelandic: Bóluefnið vekur upp sértæk vessamótefni gegn yfirborðsmótefnisvaka lifrarbólgu B veiru (antiHBsAg).
English: - At birth, one dose of hepatitis B immunoglobulin (within 24 hours).
Icelandic: - Við fæðingu, einn skammtur af lifrarbólgu B immunóglóbulíni (innan 24 klst.).
English: There have been reports of administration of higher than recommended doses of HBVAXPRO.
Icelandic: Tilkynnt hefur verið um að gefnir hafi verið stærri skammtar af HBVAXPRO en ráðlagt er.