FrancophonIA/ELRC3.0 huggingface dataset:
English: Among 130 vaccinated infants, the estimated efficacy in prevention of chronic hepatitis B infection was 95 % as compared to the infection rate in untreated historical controls.
Icelandic: B 95 % samanborið við sýkingartíðni þeirra sem ekki höfðu verið meðhöndlaðir.
English: Skin and subcutaneous tissue disorders Rash, Alopecia, Pruritus, Urticaria, Erythema multiforme, Angioedema, Eczema
Icelandic: Húð og undirhúð Útbrot, skalli, kláði, ofsakláði, regnbogaroðasótt, ofsabjúgur, exem.
English: Read all of this leaflet carefully before you are vaccinated because it contains important information for you.
Icelandic: Lesið allan fylgiseðilinn vandlega áður en byrjað er að nota lyfið.
English: The schedule is two injections with an interval of one month followed by a third injection 6 months after the first administration (0, 1, 6 months).
Icelandic: Gert er ráð fyrir tveimur inndælingum með eins mánaðar millibili og síðan þriðju inndælingunni 6 mánuðum eftir fyrstu inndælinguna (0, 1, 6 mánuðir).
English: Hepatitis B virus surface antigen, recombinant (HBsAg) * ................... 5 micrograms Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.25 milligram Al
Icelandic: B veiru, raðbrigða (HBsAg)* ...... 5 míkrógrömm, Aðsogað á ókristallað álhýdroxýfosfatsúlfat (0,25 milligrömm
English: • Joint pain, Arthritis, Muscle pain, Pain in extremity
Icelandic: • liðverkir, liðagigt, vöðvaverkir, verkir í útlimum
English: This vaccine may contain traces of formaldehyde and potassium thiocyanate, which are used during the manufacturing process.
Icelandic: Bóluefnið gæti innihaldið leifar af formaldehýði og kalíum tíocýanati, sem eru notuð í framleiðsluferlinu.
English: The vial should be well shaken until a slightly opaque white suspension is obtained.
Icelandic: Hristið hettuglasið vel þar til hvít ógagnsæ dreifa fæst.
English: HBVAXPRO 10 micrograms
Icelandic: HBVAXPRO 10 míkrógrömm
English: If you miss a scheduled injection, talk to your doctor, pharmacist or nurse.
Icelandic: Ef ein inndæling gleymist skalt þú hafa samband við lækninn, lyfjafræðinginn eða hjúkrunarfræðinginn.
English: EU/1/01/183/029 - pack of 10 EU/1/01/183/032 - pack of 20
Icelandic: EU/1/01/183/029 - Pakkningastærð 10 EU/1/01/183/032 - Pakkningastærð 20
English: - In the case of unvaccinated or incompletely vaccinated individuals, additional doses should be given as in the recommended immunisation schedule.
Icelandic: - Ef um ræðir einstaklinga sem ekki hafa hlotið bólusetningu eða ef ekki hefur verið lokið við bólusetningu skal gefa inn aukaskammta í samræmi við bólusetningaráætlunina.
English: If you forget one dose of HBVAXPRO 10 micrograms
Icelandic: Ef gleymist að gefa HBVAXPRO 10 míkrógrömm
English: IM use
Icelandic: Skammtar
English: Talk to your doctor, pharmacist or nurse before you receive HBVAXPRO 40 micrograms.
Icelandic: Leitið ráða hjá lækninum, lyfjafræðingi eða hjúkrunarfræðingnum áður en HBVAXPRO 40 míkrógrömm er notað.
English: 0.5 ml of suspension in vial (glass) with stopper (gray butyl rubber) and aluminum seals with plastic flip caps with an empty sterile injection syringe with needle.
Icelandic: 0,5 ml af dreifu í hettuglasi (gler) með tappa (grátt bútýlgúmmí) og með innsigli úr áli með smelluloki úr plasti.
English: If you forget one dose of HBVAXPRO 40 micrograms
Icelandic: Ef gleymist að gefa HBVAXPRO 40 míkrógrömm
English: Breast-feeding: There is no clinical data on the use of HBVAXPRO on breast-feeding women.
Icelandic: Brjóstagjöf Ekki eru til klínískar upplýsingar um notkun HBVAXPRO hjá konum með barn á brjósti.
English: Other side effects are reported very rarely:
Icelandic: Aðrar aukaverkanir sem koma örsjaldan fyrir:
English: BATCH NUMBER
Icelandic: Pakkningarstærð
English: The most common side effects seen are injection-site reactions: transient soreness, erythema, induration.
Icelandic: Algengustu aukaverkanir eru viðbrögð á stungustað: tímabundin eymsli, hörundsroði, herslismyndun.
English: This vaccine is indicated for active immunisation against hepatitis B virus infection caused by all known subtypes in individuals from birth through 15 years of age considered at risk of exposure to hepatitis B virus.
Icelandic: B veirusýkingu af völdum allra þekktra undirflokka veirunnar hjá einstaklingum frá fæðingu að 15 ára aldri sem talin eru vera í sýkingarhættu af völdum lifrarbólgu
English: Amorphous aluminium hydroxyphosphate sulfate is included in this vaccine as an adsorbant.
Icelandic: Bóluefnið inniheldur ókristallað álhýdroxýfosfatsúlfat sem aðsogsefni.
English: 0.5 ml of suspension in pre-filled syringe (glass) without needle with a plunger stopper (gray chlorobutyl).
Icelandic: 0,5 ml af dreifu í áfylltri sprautu (gler) án nálar með tappa (grátt klóróbútýl).
English: • Skin reactions such as eczema, Rash, Itching, Hives and Skin blistering, Hair loss
Icelandic: • einkenni frá húð s.s. exem, útbrot, hárlos, kláði, ofsakláði og blöðrumyndun
English: A booster dose must be considered in these vaccinees if the antibody level against hepatitis B virus surface antigen (anti-HBsAg) after primary series is less than 10 IU/l.
Icelandic: Íhuga skal örvunarskammt hjá þeim sem hafa verið bólusettir ef styrkur mótefnis gegn yfirborðsmótefnivaka lifrarbólgu B (anti-HBsAg) veiru eftir fyrstu bólusetningarmeðferð er lægri en 10 AE/l.
English: These factors include older age, male gender, obesity, smoking, route of administration and some chronic underlying diseases.
Icelandic: Komið hafa í ljós ýmsir þættir sem draga úr mótefnasvörun við bóluefni gegn lifrarbólgu B. Þessir þættir eru m.a. hár aldur, karlkyns einstaklingar, offita, reykingar, aðferð við lyfjagjöf og sumir langvinnir, undirliggjandi sjúkdómar.
English: Reduced risk of Hepatocellular Carcinoma
Icelandic: Minni áhætta á lifrarfrumukrabbameini
English: How to store HBVAXPRO 40 micrograms
Icelandic: Hvernig geyma á HBVAXPRO 40 míkrógrömm
English: How to store HBVAXPRO 5 micrograms
Icelandic: Hvernig geyma á HBVAXPRO 5 míkrógrömm
English: HBVAXPRO is indicated for the active immunisation against hepatitis B virus infection caused by all known subtypes in predialysis and dialysis adult patients.
Icelandic: HBVAXPRO er ætlað til bólusetningar gegn sýkingum af völdum allra þekktra undirflokka lifrarbólgu
English: - The first dose of the vaccine should be given within 7 days of birth and can be administered simultaneously with hepatitis B immunoglobulin at birth, but at a separate injection site.
Icelandic: - Gefa skal fyrsta skammt af bóluefninu innan 7 daga frá fæðingu og það má gefa samtímis lifrarbólgu B immunóglóbulíni, en ekki á sama stungustað.
English: Talk to your doctor, pharmacist or nurse before you receive HBVAXPRO 10 micrograms.
Icelandic: Leitið ráða hjá lækninum, lyfjafræðingi eða hjúkrunarfræðingnum áður en HBVAXPRO 10 míkrógrömm er notað.
English: How to store HBVAXPRO 10 micrograms
Icelandic: Hvernig geyma á HBVAXPRO 10 míkrógrömm
English: Others vaccines and HBVAXPRO 40 micrograms
Icelandic: Notkun annarra bóluefna samhliða HBVAXPRO 40 míkrógrömm
English: This vaccine is indicated for active immunisation against hepatitis B virus infection caused by all known subtypes in individuals 16 years of age or more considered at risk of exposure to hepatitis B virus.
Icelandic: B veirusýkingu af völdum allra þekktra undirflokka veirunnar hjá einstaklingum 16 ára og eldri sem talin eru vera í sýkingarhættu af völdum lifrarbólgu
English: Pack size of 1, 10, 20
Icelandic: - Pakkningastærð: 1, 10, 20,
English: For any information about this vaccine, please contact the local representative of the Marketing Authorisation Holder.
Icelandic: Hafið samband við fulltrúa markaðsleyfishafa á hverjum stað ef óskað er upplýsinga um bóluefnið:
English: Others vaccines and HBVAXPRO 10 micrograms
Icelandic: Notkun annarra bóluefna samhliða HBVAXPRO 10 míkrógrömm
English: Dosage recommendations for neonates born to mothers who are hepatitis B virus carriers
Icelandic: Skammtar fyrir nýbura mæðra sem bera lifrarbólgu
English: In addition, persistence of vaccine-induced immunologic memory for hepatitis B virus surface antigen (HBsAg) has been demonstrated through an anamnestic antibody response to a booster dose of a previous formulation of Merck's recombinant hepatitis B vaccine.
Icelandic: Þessu til viðbótar, hefur verið sýnt fram á stöðugleika bóluefnisvekjandi ónæmisminnis fyrir yfirborðsmótefnavaka lifrarbólgu B veiru (HBsAg) með upprifjandi mótefnisviðbrögðum við örvunarskammti með fyrri samsetningu af lifrarbólgu B bóluefni frá Merck framleiddu með raðbrigða erfðatækni.
English: • Fatigue, Fever, Vague illness, Flu-like symptoms
Icelandic: • þreyta, hiti, vanlíðan, flensu-lík einkenni
English: Pregnancy:
Icelandic: Upphafsbólusetning:
English: What HBVAXPRO 5 micrograms looks like and contents of the pack
Icelandic: Lýsing á útliti HBVAXPRO 5 míkrógrömm og pakkningastærðir
English: What you need to know before you use HBVAXPRO 40 micrograms
Icelandic: Áður en byrjað er að nota HBVAXPRO 40 míkrógrömm
English: Do not use HBVAXPRO 40 micrograms - if you are allergic to hepatitis B surface antigen or to any of the other ingredients of HBVAXPRO
Icelandic: Ekki má nota HBVAXPRO 40 míkrógrömm ef um er að ræða ofnæmi fyrir yfirborðsmótefnavökum lifrarbólgu
English: MANUFACTURER'S BATCH NUMBER
Icelandic: FRAMLEIÐANDANS
English: The upper arm muscle is the preferred site for injection in children and adolescents.
Icelandic: Best er að sprauta nýbura og ungbörn í efri hluta læris en börn og unglinga í upphandleggsvöðva.
English: Musculoskeletal, connective tissue and bone disorders Arthralgia, Arthritis, Myalgia, Pain in extremity
Icelandic: Stoðkerfi og bandvefur Liðverkir, liðbólga, vöðvaþrautir, verkir í útlimum.
English: In addition, persistence of vaccine-induced immunologic memory for hepatitis B virus surface antigen (HBsAg) has been demonstrated through an anamnestic antibody response to a booster dose of a previous formulation of Merck's recombinant hepatitis B vaccine in healthy adults.
Icelandic: Þessu til viðbótar, hefur verið sýnt fram á stöðugleika bóluefnisvekjandi ónæmisminnis fyrir yfirborðsmótefnavaka lifrarbólgu B veiru (HBsAg) með upprifjandi mótefnisviðbrögðum við örvunarskammti með fyrri samsetningu af lifrarbólgu B bóluefni frá Merck, framleiddu með raðbrigða erfðatækni .
English: 1 ml of suspension in pre-filled syringe (glass) without needle with a plunger stopper (gray chlorobutyl).
Icelandic: 1 ml af dreifu í áfylltri sprautu (gler) án nálar með tappa (grátt klóróbútýl).
English: A booster dose must be considered in these vaccinees if the antibody level against hepatitis B virus surface antigen is less than 10 IU/l.
Icelandic: Íhuga skal örvunarskammt af þessu bóluefni ef mótefni gegn yfirborðsmótefnavaka lifrarbólgu B eru lægri en 10 AE/l.
English: HBVAXPRO 5 micrograms - single dose vial - Pack of 1, 10 HBVAXPRO 5 micrograms - single dose vial + syringe with needle - Pack of 1
Icelandic: - Pakkningastærð: 1,10 HBVAXPRO 5 míkrógrömm - stakskammta hettuglas + sprauta með nál
English: Do not use HBVAXPRO 10 micrograms - if you are allergic to hepatitis B surface antigen or to any of the other ingredients of HBVAXPRO
Icelandic: Ekki má nota HBVAXPRO 10 míkrógrömm ef um er að ræða ofnæmi fyrir yfirborðsmótefnavökum lifrarbólgu
English: In vaccinees with an impaired immune system, administration of additional doses of vaccine should be considered if the antibody level against hepatitis B virus surface antigen (anti-HBsAg) is less than 10 IU/l.
Icelandic: Íhuga ætti að gefa einstaklingum sem hafa verið bólusettir og eru með skerta ónæmissvörun viðbótarskammt af bóluefninu ef styrkur mótefna gegn yfirborðsmótefnavaka lifarbólgu B (antiHbsAg) er minni en 10 AE/l.
English: EU/1/01/183/027 - pack of 10 EU/1/01/183/028 - pack of 1
Icelandic: EU/1/01/183/027 - Pakkningastærð 10 EU/1/01/183/028 - Pakkningastærð 1
English: In accordance with standard medical practice for hepatitis B vaccine administration, regular antibody testing should be done in hemodialysis patients.
Icelandic: Samkvæmt læknisfræðilegum stöðlum um lyfjagjöf á bóluefni gegn lifrarbólgu
English: 0.5 ml of suspension in pre-filled syringe (glass) with 1 separate needle with a plunger stopper (gray chlorobutyl).
Icelandic: 0,5 ml af dreifu í áfylltri sprautu (gler) með 1 lausri nál, með tappa (grátt klóróbutýl).
English: HBVAXPRO 10 micrograms is a suspension for injection in a syringe.
Icelandic: HBVAXPRO 10 míkrógrömm er stungulyf, dreifa, í sprautu.
English: What HBVAXPRO 40 micrograms looks like and contents of the pack
Icelandic: Lýsing á útliti HBVAXPRO 40 míkrógrömm og pakkningastærðir
English: EU/1/01/183/007 - pack of 1 EU/1/01/183/008 - pack of 10
Icelandic: EU/1/01/183/007 - Pakkningastærð 1 EU/1/01/183/008 - Pakkningastærð 10
English: HBVAXPRO 5 micrograms - single dose pre-filled syringe with 1 separate needle - Pack of 1, 10
Icelandic: HBVAXPRO 5 míkrógrömm - stakskammta áfyllt sprauta með 1 lausri nál - Pakkningastærð:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Icelandic: Samantekt á aukaverkunum, settar upp í töflu
English: It can be expected that hepatitis D will also be prevented by immunisation with HBVAXPRO as hepatitis D does not occur in the absence of hepatitis B infection.
Icelandic: Ætla má að ónæmisaðgerð með HBVAXPRO veiti einnig vörn gegn lifrarbólgu
English: Guillain-Barre Syndrome, Inflammation of the nerve of the eye that leads to impaired vision, Brain inflammation, Exacerbation of multiple sclerosis, Multiple sclerosis, Convulsions, Headache,
Icelandic: • einkenni frá taugakerfinu s.s. náladofi, andlitslömun, bólga í taugum þar með talið Guillain-Barré heilkenni, bólga í augntaug sem leiðir til sjónskerðingar, bólga í heila, versnun á heila- og mænusiggi, heila- og mænusigg, krampar, höfuðverkur, svimi og yfirlið
English: EU/1/01/183/001 - pack of 1 EU/1/01/183/018 - pack of 10 EU/1/01/183/019 - pack of 1
Icelandic: EU/1/01/183/001 - Pakkningastærð 1 EU/1/01/183/018 - Pakkningastærð 10 EU/1/01/183/019 - Pakkningastærð 1
English: HBVAXPRO (see section 6.)
Icelandic: B veiru eða einhverju öðru innihaldsefni HBVAXPRO (talin upp í kafla 6).
English: What HBVAXPRO 10 micrograms looks like and contents of the pack
Icelandic: Lýsing á útliti HBVAXPRO 10 míkrógrömm og pakkningastærðir
English: 1 ml of suspension in pre-filled syringe (glass) with 1 separate needle with a plunger stopper (gray chlorobutyl).
Icelandic: 1 ml af dreifu í áfylltri sprautu (gler) með 1 lausri nál, með tappa (grátt klóróbútýl).
English: The upper arm muscle is the preferred site for injection in adults.
Icelandic: Best er að sprauta fullorðna í upphandleggsvöðva.
English: HBVAXPRO 5 micrograms suspension for injection Hepatitis B vaccine (rDNA)
Icelandic: HBVAXPRO 5 míkrógrömm stungulyf, dreifa Lifrarbólgu B bóluefni (rDNA)
English: HBVAXPRO 10 micrograms - single dose pre-filled syringe with 1 separate needle - Pack of 1, 10 HBVAXPRO 10 micrograms - single dose pre-filled syringe with 2 separate needles - Pack of 1, 10,
Icelandic: - Pakkningastærð: 1, 10 HBVAXPRO 10°míkrógrömm - stakskammta áfyllt sprauta með 1 lausri nál - Pakkningastærð:
English: HBVAXPRO 10 micrograms - single dose pre-filled syringe without needle - Pack of 1, 10
Icelandic: HBVAXPRO 10 míkrógrömm - stakskammta áfyllt sprauta án nálar
English: HBVAXPRO 10 micrograms suspension for injection in pre-filled syringe Hepatitis B vaccine (rDNA)
Icelandic: HBVAXPRO 10 míkrógrömm stungulyf, dreifa í áfylltri sprautu Lifrarbólgu B bóluefni (rDNA)
English: The following undesirable effects have been reported following the widespread use of the vaccine.
Icelandic: Tilkynnt hefur verið um eftirfarandi aukaverkanir í kjölfarið á víðtækri notkun á bóluefninu.
English: Pregnancy and breast-feeding
Icelandic: B veiru og mótefnisvaka lifrarbólgu
English: HBVAXPRO may be administered at the same time as with some other vaccines, using separate sites and syringes.
Icelandic: HBVAXPROmá gefa samtímis sumum öðrum bóluefnum ef notaður er annar stungustaður og önnur sprauta.
English: HBVAXPRO 5 micrograms is a suspension for injection in a syringe.
Icelandic: HBVAXPRO 5 míkrógrömm er stungulyf, dreifa, í sprautu.
English: Date of first authorisation: 27/04/2001 Date of last renewal: 17/03/2011
Icelandic: 27. apríl 2001 Dagsetning endurnýjunar markaðsleyfis:
English: HBVAXPRO 40 micrograms, suspension for injection Hepatitis B vaccine (recombinant DNA)
Icelandic: HBVAXPRO 40 míkrógrömm stungulyf, dreifa Lifrarbólgu B bóluefni (raðbrigða DNA)
English: However, because data are insufficient concerning the safety of hepatitis B vaccine when additional doses in excess of the recommended series are administered, revaccination following completion of the primary series is not routinely recommended.
Icelandic: Samt sem áður er venjulega ekki mælt með endurbólusetningu þar sem ekki liggja fyrir nægilegar upplýsingar um öryggi lifrarbólgu
English: HBVAXPRO 10 micrograms, suspension for injection in pre-filled syringe Hepatitis B vaccine (recombinant DNA)
Icelandic: HBVAXPRO 10 míkrógrömm, stungulyf, dreifa í áfylltri sprautu Lifrarbólgu B bóluefni (raðbrigða DNA)
English: 1 ml of suspension in pre-filled syringe (glass) with 2 separate needles with a plunger stopper (gray chlorobutyl).
Icelandic: 1 ml af dreifu í áfylltri sprautu (gler) með 2 lausum nálum, með tappa (grátt klóróbútýl).
English: Merck Sharp & Dohme OÜ, Tel: +372.614.4200 msdeesti@merck.com
Icelandic: +372.614.4200 msdeesti@merck.com
English: 1 ml of suspension in vial (glass) with stopper (gray butyl rubber) and aluminum seals with plastic flip caps.
Icelandic: 1 ml af dreifu í hettuglasi (gler) með tappa (grátt bútýlgúmmí) og innsigli úr áli og smelluloki úr plasti.
English: Special dosage recommendations:
Icelandic: Sérstakir skammtar:
English: Suspension for injection 1 single dose 1 ml vial
Icelandic: Stungulyf, dreifa Stakskammta 1 ml hettuglas
English: HBVAXPRO 40 micrograms is a suspension for injection in a vial.
Icelandic: HBVAXPRO 40 míkrógrömm er stungulyf, dreifa, í hettuglasi.
English: Eye Disorders Uveitis
Icelandic: B. FYLGISEÐILL
English: Respiratory, thoracic and mediastinal disorders Bronchospasm-like symptoms
Icelandic: Öndunarfæri, brjósthol og miðmæti Einkenni lík berkjukrampa
English: The upper arm muscle is the preferred site for injection in adults and adolescents.
Icelandic: Best er að sprauta fullorðna og unglinga í upphandleggsvöðva.
English: HBVAXPRO 10 micrograms - single dose vial - Pack of 1, 10
Icelandic: HBVAXPRO 10°míkrógrömm - stakskammta áfyllt sprauta með 2 lausum nálumPakkningastærð: 1, 10, 20
English: It can be expected that hepatitis D will also be prevented by immunisation with HBVAXPRO as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
Icelandic: D þar sem lifrarbólga D (af völdum delta veiru) verður ekki ef lifrarbólgu
English: HBVAXPRO 5 micrograms suspension for injection in pre-filled syringe Hepatitis B vaccine (rDNA)
Icelandic: HBVAXPRO 5 míkrógrömm stungulyf, dreifa í áfylltri sprautu Lifrarbólgu B bóluefni (rDNA)
English: The vaccine should be inspected visually in order to detect any appearance of precipitate or discolouring of the content prior to administration.
Icelandic: Skoða skal bóluefnið með tilliti til útfellinga eða litabreytinga á innihaldinu áður en lyfið er gefið.
English: HBVAXPRO 5 micrograms, suspension for injection in pre-filled syringe Hepatitis B vaccine (recombinant DNA)
Icelandic: HBVAXPRO 5 míkrógrömm stungulyf, dreifa í áfylltri sprautu Lifrarbólgu B bóluefni (raðbrigða DNA)
English: HBVAXPRO 10 micrograms, suspension for injection Hepatitis B vaccine (recombinant DNA)
Icelandic: HBVAXPRO 10 míkrógrömm, stungulyf, dreifa Lifrarbólgu B bóluefni (raðbrigða DNA)
English: Pharmacotherapeutic group: anti-infectious, ATC code: J07BC01
Icelandic: Sýkingalyf, ATC flokkur:
English: What HBVAXPRO 5 micrograms contains
Icelandic: HBVAXPRO 5 míkrógrömm inniheldur
English: (e.g. formaldehyde and potassium thiocyanate), see sections 6.1 and 2.
Icelandic: Þekkt ofnæmi fyrir virka efninu eða einhverju hjálparefnanna, eða snefilefnanna (t.d. formaldehýði og kalíum tíocýanati), sjá kafla 6.1 og 6.2.
English: HBVAXPRO 10 micrograms is not indicated in this subset of paediatric population.
Icelandic: HBVAXPRO 10míkrógrömm er ekki ætlað einstaklingum undir 16 ára aldri.
English: What you need to know before you receive HBVAXPRO 10 micrograms
Icelandic: Áður en byrjað er að nota HBVAXPRO 10 míkrógrömm
English: Individuals 16 years of age or more: 1 dose (1 ml) at each injection.
Icelandic: Einn skammtur (1 ml) fyrir hverja inndælingu.
English: Sodium chloride Borax
Icelandic: 13. LOTUNÚMER
English: Individuals from birth through 15 years of age: 1 dose (0.5 ml) at each injection:
Icelandic: Einstaklingar frá fæðingu að 15 ára aldri:
English: Tell your doctor, pharmacist or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Icelandic: Látið lækninn, lyfjafræðing eða hjúkrunarfræðinginn vita um öll önnur lyf sem eru notuð, hafa nýlega verið notuð eða kynnu að verða notuð, einnig þau sem fengin eru án lyfseðils.
English: Individuals from birth through 15 years of age: 1 dose (0.5 ml) at each injection.
Icelandic: Einn skammtur (0,5 ml) fyrir hverja inndælingu.
English: HBVAXPRO 5 micrograms, suspension for injection Hepatitis B vaccine (recombinant DNA)
Icelandic: HBVAXPRO 5 míkrógrömm, stungulyf, dreifa Lifrarbólgu B bóluefni (raðbrigða DNA)
English: What HBVAXPRO 10 micrograms contains
Icelandic: HBVAXPRO 10 míkrógrömm inniheldur
English: What HBVAXPRO 40 micrograms contains
Icelandic: HBVAXPRO 40 míkrógrömm inniheldur
English: • Vomiting, Nausea, Diarrhoea, Abdominal pain
Icelandic: • uppköst, ógleði, niðurgangur, kviðverkur
English: For clinical or laboratory monitoring regarding immunocompromised individuals or individuals with known or presumed exposure to hepatitis B virus, see section 4.2.
Icelandic: Saga um ofnæmi fyrir virka efninu eða einhverju hjálparefnanna eða snefilefnanna (t.d. formaldehýði og kalíum tíocýanati), sjá kafla 6.1 og 2.
English: Gastrointestinal disorders Vomiting, Nausea, Diarrhoea, Abdominal pain
Icelandic: Meltingarfæri Uppköst, ógleði, niðurgangur, kviðverkir
English: HBVAXPRO 40 micrograms - single dose vial - Pack of 1
Icelandic: HBVAXPRO 40 míkrógrömm - stakskammta hettuglas
English: This vaccine is indicated for active immunisation against hepatitis B virus infection caused by all known subtypes in predialysis and dialysis adult patients.
Icelandic: B veirusýkingu af völdum allra þekktra undirflokka hjá sjúklingum á leið í skilun og fullorðnum skilunarsjúklingum.
English: Before use, the vial should be well shaken.
Icelandic: Hettuglasið skal hrista vel upp fyrir notkun.
English: Suspension for injection Slightly opaque white suspension.
Icelandic: Stungulyf, dreifa Aðeins mött hvít dreifa.
English: Because of the long incubation period of hepatitis B, it is possible for unrecognised hepatitis B infection to be present at the time of vaccination.
Icelandic: D þar sem lifrarbólga D kemur ekki upp ef að lifrarbólga B er ekki til staðar.
English: Talk to your doctor, pharmacist or nurse before you or your child receive HBVAXPRO 5 micrograms.
Icelandic: Leitið ráða hjá lækninum, lyfjafræðingi eða hjúkrunarfræðingnum áður en HBVAXPRO 5 míkrógrömm er notað
English: How much and how often to take?
Icelandic: Hve mikið á að gefa og hve oft?
English: AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Icelandic: Ελλάδα AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
English: For example, do not warm it in a microwave or in hot water
Icelandic: Til dæmis má ekki hita það í örbylgjuofni eða í heitu vatni
English: • Do not warm Humira in any other way.
Icelandic: Ekki hita Humira á nokkurn hátt.
English: Check the inspection window.
Icelandic: Skoðaðu í gluggann.
English: Wash and dry your hands.
Icelandic: Þvoðu hendur og þurrkaðu.
English: 36400 O Porriño Pontevedra, Spain and
Icelandic: 36400 O Porriño Pontevedra
English: • Do not touch the needle with your fingers or let the needle touch anything
Icelandic: Ekki snerta nálina með fingrunum eða láta nálina snerta neitt
English: Do not use the product after the month and year shown.
Icelandic: Ekki nota lyfið eftir mánuðinn og árið sem þar kemur fram.