FrancophonIA/ELRC3.0 huggingface dataset:
English: These babies may require respiratory monitoring for 48-72h following the administration of the first two or three doses of Infanrix hexa.
Icelandic: Nauðsynlegt getur verið að hafa eftirlit með öndun hjá þessu börnum í 48-72 klst.
English: After booster vaccination (post-dose 4), at least 98.4% of children had developed seroprotective or seropositive antibody levels against each of the vaccine antigens.
Icelandic: Eftir örvunarónæmisaðgerð (eftir-skammtur 4) hafði a.m.k 98,4% ungbarna þróað sermisvörn eða sermisjákvæð mótefnagildi gegn hverjum mótefnavaka bóluefnisins.
English: 2 Adverse reactions from spontaneous reporting.
Icelandic: § Fjöldi þátttakenda úr 2 klínískum rannsóknum
English: • Your child will have a total of two or three injections with at least 1 month between each injection.
Icelandic: Barnið fær samtals tvær eða þrjár sprautur og líður a.m.k.
English: Read all of this leaflet carefully before your child receives this vaccine because it contains important information for you.
Icelandic: Lesið allan fylgiseðilinn vandlega áður en barnið fær bóluefnið.
English: In extremely rare cases, allergic reactions mimicking serum sickness, paralysis, neuropathy, neuritis, hypotension, vasculitis, lichen planus, erythema multiforme, arthritis, muscular weakness, GuillainBarré syndrome, encephalopathy, encephalitis and meningitis have been reported.
Icelandic: Í örfáum tilfellum hefur verið greint frá ofnæmisviðbrögðum sem líkjast sermissótt, lömun, taugakvilla, taugabólgu, lágþrýstingi, æðabólgu, flatskæningi, regnbogaroða, liðbólgu, máttleysi í vöðvum, GuillainBarré heilkenni, heilakvilla, heilabólgu og heilahimnubólgu.
English: The vaccine suspension should be inspected visually before and after reconstitution for any foreign particulate matter and/or abnormal physical appearance.
Icelandic: Bóluefnið skal skoða fyrir og eftir blöndun m.t.t. aðskotahluta og/eða óeðlilegs útlits.
English: As with any vaccine, a protective immune response may not be elicited in all vaccinees (see section
Icelandic: Eins og á við um öll bóluefni er ekki víst að verndandi ónæmissvörun náist hjá öllum sem bólusettir eru (sjá kafla 5.1).
English: The immunogenicity of a booster dose at 18 to 24 months of age was evaluated in approximately 200 preterm infants.
Icelandic: örvunarskammts við 18 til 24 mánaða aldur var metin hjá u.þ.b. 200 fyrirburum.
English: Hib powder: lactose anhydrous
Icelandic: Hib-duft: vatnsfrír mjólkursykur
English: Infanrix hexa will confer an anti-PRP immune response (cut-off ≥ 0.15µg/ml) in at least 84% of the infants.
Icelandic: Infanrix hexa mun gefa and-PRP ónæmissvörun (samþykkt viðmiðunargildi ≥ 0,15 míkróg/ml) hjá a.m.k.
English: After a 3-dose primary vaccination schedule, at least 95.7% of infants had developed seroprotective or seropositive antibody levels against each of the vaccine antigens.
Icelandic: Eftir 3-skammta áætlun frumónæmisaðgerða hafði a.m.k 95,7% ungbarna þróað sermisvörn eða sermisjákvæð mótefnagildi gegn hverjum mótefnavaka bóluefnisins.
English: 1 dose (0.5 ml)
Icelandic: 50 x 1 skammtur (0,5 ml)
English: Component of a multipack comprising 5 packs, each containing 10 vials and 10 pre-filled syringes without needles
Icelandic: Hluti fjölpakkningar sem inniheldur 5 pakkningar, sem hver inniheldur 10 hettuglös og 10 áfylltar sprautur án nála
English: Protective immunity against the three poliovirus types and PRP was observed in at least 91.0% of children and against diphtheria and tetanus in at least 64.7% of children.
Icelandic: Ónæmisvörn gegn mænusóttarveirunum þremur og Haemophilus influenzae gerð b sást hjá a.m.k. 91,0% barnanna og gegn barnaveiki og stífkrampa hjá a.m.k. 64,7% barnanna.
English: Percentage of subjects with antibody titres indicative of seroprotection / seropositivity one month after 2-dose primary and booster vaccination with Infanrix hexa
Icelandic: Hundraðshlutfall einstaklinga með mótefnatítra sem benda til sermisvarnar/sermisjákvæðni einum mánuði eftir 2-skammta frumónæmisaðgerð og örvunarbólusetningu með Infanrix hexa
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 dose
Icelandic: INNIHALD TILGREINT SEM ÞYNGD, RÚMMÁL EÐA FJÖLDI EININGA
English: Syringe plunger
Icelandic: Ending ónæmissvörunar
English: 10 vials and 10 pre-filled syringes 10 x 1 dose (0.5 ml)
Icelandic: 10 hettuglös og 10 áfylltar sprautur 10 x 1 skammtur (0,5 ml)
English: Percentage of subjects with antibody titres indicative of seroprotection / seropositivity one month after 3-dose primary and booster vaccination with Infanrix hexa
Icelandic: Hundraðshlutfall einstaklinga með mótefnatítra sem benda til sermisvarnar/sermisjákvæðni einum mánuði eftir 3-skammta frumónæmisaðgerð og örvunarbólusetningu með Infanrix hexa
English: Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (adsorbed).
Icelandic: Barnaveiki (D), stífkrampa (T), kíghósta (frumulaust, hlutar) (Pa), lifrarbólgu B (rDNA) (HBV), mænusóttar (deytt) (IPV) og samtengt Haemophilus influenzae gerð b (Hib) bóluefni (aðsogað).
English: Prophylactic administration of antipyretics before or immediately after vaccine administration can reduce the incidence and intensity of post-vaccination febrile reactions.
Icelandic: Varnandi meðferð með hitalækkandi lyfjum, fyrir eða rétt eftir gjöf bóluefnis, getur dregið úr tíðni og styrkleika hitaviðbragða eftir bólusetningu.
English: Infanrix hexa should not be given if any of the above apply to your child.
Icelandic: Infanrix hexa ef eitthvað af ofangreindu á við um barnið.
English: • Experience with hepatitis B vaccine:
Icelandic: Reynsla af bóluefnum gegn lifrarbólgu B:
English: GSK Vaccines GmbH Emil-von-Behring-Str. 76, D-35041 Marburg Germany
Icelandic: 76, D-35041 Marburg Þýskaland
English: The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunisation series to very preterm infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
Icelandic: Þegar verið er að frumbólusetja mikla fyrirbura (sem fæddir eru ≤ 28 vikna meðgöngu) og sérstaklega þá sem hafa sögu um vanþroskuð öndunarfæri skal hafa í huga hugsanlega hættu á öndunarstöðvun og þörfina fyrir eftirlit með starfsemi öndunarfæra í 48-72 klst.
English: Filamentous Haemagglutinin1
Icelandic: Barnaveikitoxóíð1
English: Anti-PRP (0.15 µg/ml) †
Icelandic: Gegn haemophilus gerð b (anti-PRP) (0,15 míkróg/ml) †
English: The lyophilised Haemophilus influenzae type b (Hib) component is a white powder.
Icelandic: Frostþurrkaði Haemophilus influenzae b efnisþátturinn er hvítt duft.
English: redness
Icelandic: Skammtar
English: Anti-HBs (10 mIU/ml) †
Icelandic: B (10 ma.e./ml) †
English: Ask your pharmacist how to throw away medicines your child no longer uses.
Icelandic: Leitið ráða í apóteki um hvernig heppilegast er að farga lyfjum sem hætt er að nota.
English: • Store in the original package in order to protect from light.
Icelandic: Geymið í upprunalegum umbúðum til varnar gegn ljósi.
English: LIST OF EXCIPIENTS
Icelandic: Ónæmingargeta hjá fyrirburum
English: Fever ≥39.5°C was observed in 2.6% and 1.5% of infants receiving Infanrix hexa with or without Prevenar, respectively (see sections 4.4 and 4.5).
Icelandic: Infanrix hexa með Prevenar og hjá 1,5% af ungbörnum sem fengu eingöngu Infanrix hexa (sjá kafla 4.4 og 4.5).
English: Household contact study (prospective blinded)
Icelandic: Smit innan heimilis (framsýn blind)
English: 1 vial and 1 pre-filled syringe 1 dose (0.5 ml)
Icelandic: 1 hettuglas og 1 áfyllt sprauta 1 skammtur (0,5 ml)
English: This leaflet is available in all EU/EEA languages on the European Medicines Agency website.
Icelandic: Upplýsingar á íslensku eru á http://www.serlyfjaskra.is Þessi fylgiseðill er birtur á vef Lyfjastofnunar Evrópu á tungumálum allra ríkja Evrópska efnahagssvæðisins.
English: • if your child has had an allergic reaction to any vaccine against diphtheria, tetanus, whooping cough, hepatitis B, polio or Haemophilus influenzae type b.
Icelandic: ef barnið hefur fengið ofnæmisviðbrögð við einhverju bóluefni gegn barnaveiki, stífkrampa, kíghósta, lifrarbólgu B, mænusótt eða Haemophilus influenzae gerð b.
English: GlaxoSmithKline Lietuva UAB Tel. +370 5 264 90 00 info.lt@gsk.com
Icelandic: +370 5 264 90 00 info.lt@gsk.com
English: Syringe
Icelandic: Ónæmingargeta
English: Anti-PRP (0.15 µg/ml)
Icelandic: Gegn haemophilus gerð b (anti-PRP) (0,15 míkróg/ml)
English: The expected immunological response may not be obtained after vaccination of immunosuppressed patients.
Icelandic: Fullkomin ónæmissvörun næst e.t.v. ekki hjá ónæmisbældum sjúklingum.
English: The diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis (DTPa-HBV-IPV) component is a turbid white suspension.
Icelandic: Barnaveiki, stífkrampa, frumulaust kíghósta, lifrarbólgu B, óvirkt mænusóttar (DTPa-HBV-IPV) efnisþættirnir eru ógagnsæ hvít dreifa.
English: Do not administer the vaccine intravascularly or intradermally.
Icelandic: Ekki skal undir neinum kringumstæðum gefa bóluefnið í æð eða í húð.
English: • Keep this vaccine out of the sight and reach of children.
Icelandic: Geymið bóluefnið þar sem börn hvorki ná til né sjá.
English: What Infanrix hexa looks like and contents of the pack
Icelandic: Lýsing á útliti Infanrix hexa og pakkningastærðir
English: Clinical data generated with paracetamol and ibuprofen suggest that the prophylactic use of paracetamol might reduce the fever rate, while prophylactic use of ibuprofen showed a limited effect in reducing fever rate.
Icelandic: Klínískar niðurstöður sem fengust við notkun parasetamóls og íbúprófens benda til þess að varnandi meðferð með parasetamóli geti dregið úr tíðni hita, en varnandi meðferð með íbúprófeni reyndist hafa takmörkuð áhrif á tíðni hita.
English: Fever >39.5°C, injection site reactions,
Icelandic: Hiti > 39,5°C, viðbrögð á stungustað þ.m.t. herslismyndun, staðbundin bólga á stungustað (> 50 mm)1
English: Efficacy study (NIH sponsored)
Icelandic: Rannsókn á vernd (kostuð af NIH)
English: Infanrix hexa, Powder and suspension for suspension for injection in a pre-filled syringe Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (adsorbed).
Icelandic: Infanrix hexa, stungulyfsstofn og dreifa, dreifa í áfylltri sprautu Barnaveiki (D), stífkrampa (T), kíghósta (frumulaust, hlutar) (Pa), lifrarbólgu B (rDNA) (HBV), mænusóttar (deytt) (IPV) og samtengt Haemophilus influenzae gerð b (Hib) bóluefni (aðsogað).
English: Anti-FHA (5 EL.U/ml)
Icelandic: Gegn kíghóstatoxóíði (5 EL.e./ml)
English: Percentage of subjects with antibody titres indicative of seroprotection / seropositivity after primary and booster vaccination with Infanrix hexa
Icelandic: Hundraðshlutfall einstaklinga með mótefnatítra sem benda til sermisvarnar/sermisjákvæðni eftir frumónæmisaðgerð og örvunarónæmisaðgerð með Infanrix hexa
English: Infanrix hexa, Powder and suspension for suspension for injection in a pre-filled syringe Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (adsorbed)
Icelandic: Infanrix hexa, stungulyfsstofn og dreifa, dreifa í áfylltri sprautu Barnaveiki (D), stífkrampa (T), kíghósta (frumulaust, hlutar) (Pa), lifrarbólgu B (rDNA) (HBV), mænusóttar (deytt) (IPV) og samtengt Haemophilus influenzae gerð b
English: • Whooping cough (Pertussis): a highly infectious illness that affects the airways.
Icelandic: Kíghósta: mjög smitandi sjúkdómur sem hefur áhrif á öndunarveginn.
English: Antibody (cut-off)
Icelandic: (Hib) bóluefni (aðsogað)
English: Anti-PRN (5 EL.U/ml)
Icelandic: Gegn pertaktíni (5 EL.e./ml)
English: Anti-Polio type 2 (1/8 dilution) †
Icelandic: Gegn mænusótt gerð 2 (1/8 þynning) †
English: What you need to know before your child receives Infanrix hexa
Icelandic: Áður en barnið fær Infanrix hexa
English: Diarrhoea, vomiting
Icelandic: Mænusótt: veirusýking.
English: After reconstitution: an immediate use is recommended.
Icelandic: Ráðlagt er að nota bóluefnið tafarlaust.
English: Bleeding or bruising more easily than normal (thrombocytopenia) has been reported with hepatitis B vaccines.
Icelandic: Greint hefur verið frá blæðingum eða mari af minna tilefni en venjulega (blóðflagnafæð) með lifrarbólgu B bóluefnum.
English: How Infanrix hexa is given
Icelandic: Hvernig gefa á Infanrix hexa
English: One month after primary vaccination at least 98.7% of subjects were seroprotected against diphtheria, tetanus and poliovirus types 1 and 2; at least 90.9% had seroprotective antibody levels against the hepatitis B, PRP and poliovirus type 3 antigens; and all subjects were seropositive for antibodies against FHA and PRN while 94.9% were seropositive for anti-PT antibodies.
Icelandic: Einum mánuði eftir frumónæmisaðgerð voru a.m.k. 98,7% einstaklinga með sermisvörn gegn barnaveiki, stífkrampa og mænusóttarveirum af gerð 1 og 2; a.m.k.
English: • collapse
Icelandic: Sprautulok
English: (polyribosylribitol phosphate, PRP) 3 conjugated to tetanus toxoid as carrier protein approximately 25 micrograms
Icelandic: (polyríbósýlribítól fosfat, PRP)3 samtengt stífkrampatoxóíði, sem burðarpróteini u.þ.b. 25 míkrógrömm
English: Additionally, following a 2-dose primary and booster schedule, seroprotective antibody concentrations against hepatitis B persisted in ≥ 48% of subjects 11-12 years of age.
Icelandic: B hjá ≥ 48% einstaklinga 11-12 ára.
English: Anti-Polio type 3 (1/8 dilution) †
Icelandic: Gegn mænusótt gerð 3 (1/8 þynning) †
English: Country Schedule Vaccine efficacy
Icelandic: Land Áætlun Virkni bóluefnis
English: Powder and suspension for suspension for injection.
Icelandic: MEÐ BLINDRALETRI Fallist hefur verið á rök fyrir undanþágu frá kröfu um blindraletur.
English: Anti-diphtheria (0.1 IU/ml) †
Icelandic: Gegn barnaveiki (0,1 a.e./ml) †
English: In clinical studies in which some of the vaccinees received Infanrix hexa concomitantly with Prevenar (PCV7) as a booster (4th) dose of both vaccines, fever ≥ 38.0°C was reported in 43.4% of infants receiving Prevenar and Infanrix hexa at the same time as compared to 30.5% of infants receiving the hexavalent vaccine alone.
Icelandic: Prevenar (PCV7) sem örvunar- (4.) skammt af báðum bóluefnum, var greint frá hita ≥ 38°C hjá 43,4%
English: Powder for suspension for injection
Icelandic: Upplýsingar fyrir notanda lyfsins
English: Anti-Polio type 2 (1/8 dilution)
Icelandic: Gegn mænusótt gerð 2 (1/8 þynning)
English: How Infanrix hexa works
Icelandic: Hvernig verkar Infanrix hexa
English: Bordetella pertussis antigens Pertussis toxoid (PT)1
Icelandic: Kíghóstamótefnavakar Kíghóstatoxóíð (PT)1
English: Anti-HBs (10 mIU/ml)
Icelandic: B (10 ma.e./ml)
English: Anti-tetanus (0.1 IU/ml) †
Icelandic: Gegn stífkrampa (0,1 a.e./ml) †
English: Anti-Polio type 1 (1/8 dilution) †
Icelandic: Gegn mænusótt gerð 1 (1/8 þynning) †
English: Syringe barrel
Icelandic: B bóluefni
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION DTPa HBV IPV for Infanrix hexa
Icelandic: DTPa HBV IPV fyrir Infanrix hexa Dreifa fyrir stungulyf, dreifa i.m.
English: Anti-Polio type 3 (1/8 dilution)
Icelandic: Gegn mænusótt gerð 3 (1/8 þynning)
English: Anti-PT (5 EL.U/ml)
Icelandic: Gegn þráðlaga hemagglútíni (5 EL.e./ml)
English: It makes the liver swollen.
Icelandic: Hún veldur því að lifrin bólgnar.
English: (polyribosylribitol phosphate) 2 conjugated to tetanus toxoid as carrier protein approximately 25 micrograms
Icelandic: (polyríbósýlribitól fosfat)2 samtengt stífkrampatoxóíði, sem burðarpróteini u.þ.b. 25 míkrógrömm
English: each containing 10 vials and 10 pre-filled syringes, without needles.
Icelandic: 5 pakkningum, sem hver inniheldur 10 hettuglös og 10 áfylltar sprautur, án nála.
English: (polyribosylribitol phosphate)3 conjugated to tetanus toxoid as carrier protein approximately 25 micrograms
Icelandic: (polyríbósýlribítól fosfat)3 samtengt stífkrampatoxóíði, sem burðarpróteini u.þ.b. 25 míkrógrömm
English: Nervous system disorders
Icelandic: Sýking í efri hluta öndunarfæra
English: If any of the above apply to your child (or you are not sure), talk to your doctor or pharmacist before your child is given Infanrix hexa.
Icelandic: Ræddu við lækninn eða lyfjafræðing áður en barninu er gefið Infanrix hexa ef eitthvað af ofangreindu á við um barnið (eða ef þú ert ekki viss).
English: Serological correlates of protection have been established for diphtheria, tetanus, polio, Hepatitis B and Hib.
Icelandic: Sýnt hefur verið fram á samsvarandi vörn í sermi fyrir barnaveiki, stífkrampa, mænusótt, lifrarbólgu B og Haemophilus influenzae gerð b.
English: Infanrix hexa is contraindicated if the infant or toddlers has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine.
Icelandic: Ef ung- eða smábarnið hefur fengið heilakvilla af óþekktum orsökum innan 7 daga frá fyrri ónæmisaðgerð með kíghóstabóluefni skal ekki gefa Infanrix hexa.
English: H-2100 Gödöllö
Icelandic: J07CA09
English: Anti-Polio type 1 (1/8 dilution)
Icelandic: Gegn mænusótt gerð 1 (1/8 þynning)
English: Uncommon Upper respiratory tract infection
Icelandic: Yfirborðsmótefnavaka lifrarbólgu
English: Name and address of the manufacturers of the biological active substances
Icelandic: Heiti og heimilisföng framleiðenda líffræðilegra virkra efna
English: Pre-filled syringe: suspension
Icelandic: Áfyllt sprauta: dreifa
English: Dermatitis
Icelandic: Lystarleysi
English: Powder and suspension for suspension for injection in a pre-filled syringe Vial: powder
Icelandic: Stungulyfsstofn og dreifa, dreifa í áfylltri sprautu Hettuglas: stofn
English: Lactose anhydrous
Icelandic: Vatnsfrír laktósi
English: After a 2-dose primary vaccination schedule, at least 84.3% of infants had developed seroprotective or seropositive antibody levels against each of the vaccine antigens.
Icelandic: 84,3% ungbarna þróað sermisvörn eða sermisjákvæð mótefnagildi gegn hverjum mótefnavaka bóluefnisins.
English: Anti-diphtheria (0.1 IU/ml)
Icelandic: Gegn stífkrampa (0,1 a.e./ml)
English: Hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B, polio or Hib vaccines.
Icelandic: Ofnæmi eftir fyrri gjöf bóluefna gegn barnaveiki, stífkrampa, kíghósta, lifrarbólgu B, mænusótt eða Haemophilus gerð b.
English: Infanrix hexa will not prevent disease caused by pathogens other than Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, hepatitis B virus, poliovirus or Haemophilus influenzae type b. However, it can be expected that hepatitis D will be prevented by immunisation as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
Icelandic: Infanrix hexa kemur ekki í veg fyrir sjúkdóm af völdum sýkingarvalda annarra en Corinebacterium diphteriae, Clostridium tetani, Bordetella pertussis, lifrarbólgu
English: Allergic reactions (including pruritus)2
Icelandic: Ofnæmisviðbrögð (þ.m.t. kláði)2
English: months N= 1055 (6 studies)
Icelandic: N= 1055
English: Immunogenicity in preterm infants
Icelandic: Almenn athugunarefni Fullburða ungbörn
English: Paediatric population
Icelandic: Gegn lifrarbólgu
English: Reconstitute the vaccine as described above.
Icelandic: 4. Blandaðu bóluefnið samkvæmt lýsingu hér á undan.
English: • If you have any further questions, ask your doctor or pharmacist.
Icelandic: Leitið til læknisins eða lyfjafræðings ef þörf er á frekari upplýsingum.
English: If a second dose of hepatitis B vaccine is required before this age, monovalent hepatitis B vaccine should be used.
Icelandic: B bóluefni skal nota bóluefni sem eingöngu inniheldur lifrarbólgu B bóluefni.
English: Hepatitis B surface antigen2,3
Icelandic: B yfirborðsmótefnavaki2
English: Tabulated summary of adverse reactions
Icelandic: Tafla með yfirliti yfir aukaverkanir
English: Summary of the safety profile
Icelandic: á öryggisupplýsingum
English: • fits - this may be when they have a fever These side effects have happened very rarely with Infanrix hexa as with other vaccines against whooping cough.
Icelandic: Þessar aukaverkanir hafa örsjaldan komið fram við notkun Infanrix hexa eins og við notkun annarra bóluefna gegn kíghósta.
English: 18 months
Icelandic: 18 mánuðir
English: These changes usually resolve over time.
Icelandic: Venjulega ganga þessar breytingar til baka með tímanum.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1022/001
Icelandic: MARKAÐSLEYFISNÚMER EU/1/15/1022/001
English: Polysorbate 20 (E 432)
Icelandic: Pólýsorbat 20 (E 432)
English: United Therapeutics Corporation 1040 Spring Street Silver Spring, Maryland 20910 USA
Icelandic: United Therapeutics Corporation 1040 Spring Street Silver Spring, Maryland 20910
English: This is because it is not known if the medicine can pass into breast-milk.
Icelandic: Það er vegna þess að ekki er þekkt hvort lyfið getur borist í brjóstamjólk.
English: Your doctor will do blood tests and may do eye tests while you are taking this medicine.
Icelandic: Læknirinn mun taka blóðsýni og hugsanlega gera sjónprófanir á meðan þú tekur lyfið.
English: Penn Pharmaceutical Services Limited 23-24 Tafarbaubach Industrial Estate, Tredegar, Gwent NP22 3AA
Icelandic: Penn Pharmaceutical Services Limited 23-24 Tafarbaubach Industrial Estate, Tredegar, Gwent NP22
English: Other side effects that you may experience with this medicine include:
Icelandic: Aðrar aukaverkanir sem lyfið getur haft í för með sér eru meðal annars:
English: Each course lasts one month.
Icelandic: Hver meðferðarlota tekur einn mánuð.
English: Grade 3 (sensory changes for more than 2 weeks, objective motor weakness) or Grade 4
Icelandic: Stig 3 (skynbreytingar í meira en 2 vikur, hlutlægt metinn hreyfislappleiki) eða stig 4
English: Non-clinical data reveal no special hazard for humans based on conventional studies conducted to date.
Icelandic: Forklínískar upplýsingar benda ekki til neinnar sérstakrar hættu fyrir menn á grundvelli hefðbundinna rannsókna sem framkvæmdar hafa verið hingað til.
English: You might notice the following when you first receive Unituxin and during the course of treatment:
Icelandic: Þú gætir fengið eftirfarandi aukaverkanir þegar þú færð Unituxin í fyrsta sinn og meðan á meðferð stendur:
English: If morphine is not tolerated, then fentanyl or hydromorphone may be utilised.
Icelandic: Ef morfín þolist ekki má nota fentanýl eða hýdrómorfón.
English: You will be closely monitored for these signs while being given the medicine.
Icelandic: Fylgst verður vandlega með þessum einkennum hjá þér á meðan þér er gefið lyfið.
English: During courses (months) 1, 3 and 5
Icelandic: Í meðferðarlotum (mánuðum) 1, 3 og 5
English: (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100).
Icelandic: Mjög algengar (≥1/10); algengar (≥1/100 til <1/10); sjaldgæfar (≥1/1.000 til <1/100).
English: The terminal halflife was estimated at 10 (+ 6) days.
Icelandic: Lokahelmingunartíminn var áætlaður 10 (+ 6) sólarhringar.
English: High-risk neuroblastomas are more likely to come back again after treatment.
Icelandic: Hættuleg taugakímsæxli eru líklegri til að koma fram aftur að meðferð lokinni.
English: To reduce the risk of side effects, your doctor may increase the time allowed for the Unituxin infusion up to 20 hours.
Icelandic: Til að minnka hættu á aukaverkunum kann læknirinn að lengja tímann sem Unituxin innrennslisgjöfin tekur upp í 20 klst.
English: You will be given an anti-histamine medicine which helps to prevent allergic reactions.
Icelandic: Þér verður gefið andhistamín, sem hjálpar við að koma í veg fyrir ofnæmisviðbrögð.
English: • Administer supportive measures (see section 4.4).
Icelandic: • Grípið til stuðningsaðgerða (sjá kafla 4.4).
English: Unituxin is used to treat ‘high-risk neuroblastoma' in babies, children and adolescents aged 12 months to 17 years old.
Icelandic: Unituxin er notað til að meðhöndla „hættuleg taugakímsæxli“ hjá ungbörnum, börnum og unglingum á aldrinum 12 mánaða til 17 ára.