FrancophonIA/ELRC3.0 huggingface dataset:
English: The following adverse reactions were reported as vaccine related by the investigator in individuals after a single dose of ProQuad.
Icelandic: Rannsakendur greindu frá eftirtöldum bóluefnistengdum aukaverkunum hjá börnum eftir stakan skammt af ProQuad.
English: These surveillance data actually suggest that varicella-vaccinated children may have a lower risk of herpes zoster.
Icelandic: Þessar upplýsingar varðandi eftirlit benda til þess að börn sem hafa verið bólusett gegn hlaupabólu eigi síður á hættu að fá ristil.
English: Injection site complaints (Burning and/or Stinging of short duration, Eczema, Oedema/Swelling, Hive-like rash, Hematoma, Induration, Lump, Vesicles, Wheal and Flare), Inflammation, Lip abnormality, Papillitis, Roughness/Dryness, Stiffness, Trauma, Varicella-like rash, Venipuncture site haemorrhage, Warm sensation, Warm to touch
Icelandic: Umkvartanir á stungustað (bruni og/eða skammvinnir stingir, exem, bjúgur/bólga, kláðaútbrot, margúll, hersli, hnútur, blöðrur, rauðkláðaþoti og ertiroði), bólga, óeðlileg vör, totubólga, hrjúf/þurr húð, stirðleiki, áverki, hlaupabólulík útbrot, blæðing á stungustað í bláæð, hitatilfinning, hiti við viðkomu
English: Acne, Clammy skin, Exfoliative dermatitis, Drug eruption, Exanthema, Henoch-Schönlein purpura, Livedo reticularis, Papular rash, Pruritus, Skin discolouration, Skin lesion, Zosteriform rash
Icelandic: Þrymlabólur, þvöl húð, húðbólga með skinnflögnun, lyfjaútbrot, útþotasótt, Henoch-Schönlein purpuri, aflitun húðar, dröfnuörðuútbrot, kláði, litabreyting á
English: Two doses of ProQuad administered by the IM route of administration were as immunogenic as two doses administered by the SC route in terms of antibody response rates and antibody titres to measles, mumps, rubella, and varicella.
Icelandic: Tveir skammtar af ProQuad gefnir í vöðva veittu jafn mikla mótefnamyndun og tveir skammtar gefnir undir húð hvað varðar tíðni mótefnasvörunar og þéttni mótefna gagnvart mislingum, hettusótt, rauðum hundum og hlaupabólu.
English: Following the dose of ProQuad, GMTs for measles, mumps, rubella, and varicella were similar to those following a second dose of Varicella Vaccine live (Oka/Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. administered concomitantly at separate injection sites.
Icelandic: Eftir bólusetningu með ProQuad voru gildi GMT fyrir mislinga, hettusótt og rauða hunda svipuð því sem gerist eftir annan skammt af lifandi bóluefni við hlaupabólu (Oka/Merck) og bóluefni gegn mislingum, hettusótt og rauðum hundum sem Merck & Co., Inc. framleiðir, gefin samtímis á mismunandi inndælingarstaði.
English: Agitation, Apathy, Clinging, Emotional changes, Nervousness, Restlessness
Icelandic: Óróleiki, sinnuleysi, nærvistarþörf, skapsveiflur, taugaveiklun, eirðarleysi
English: In severely immunocompromised individuals inadvertently vaccinated with measles-containing vaccine, measles inclusion body encephalitis, pneumonitis, and fatal outcome as a direct consequence of disseminated measles vaccine virus infection have been reported.
Icelandic: Greint hefur verið frá því að sjúklingar með alvarlega skert ónæmi, sem fyrir mistök voru bólusettir með bóluefni sem innihélt mislingaþátt, hafi fengið mislinga með innlyksuheilabólgu (measles inclusion body encephalitis) eða lungnabólgu (pneumonitis) og þeir jafnvel dáið, vegna útbreiddrar sýkingar af völdum bóluefnisstofns mislingaveirunnar.
English: Rubella (titre ≥10 IU/mL)
Icelandic: Rauðir hundar (títur ≥10 a.e./ml)
English: These results were similar to the immune response rates induced by concomitant administration of a single dose of Varicella Vaccine live (Oka/Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. at separate injection sites.
Icelandic: Þessar niðurstöður voru sambærilegar við ónæmissvörun af völdum samtímis notkunar staks skammts af lifandi bóluefni við hlaupabólu (Oka/Merck) og bóluefnis gegn mislingum, hettusótt og rauðum hundum sem Merck & Co., Inc. framleiðir, gefið á mismunandi inndælingarstaði.
English: Inject the entire content of the syringe into the vial containing the powder.
Icelandic: Dælið öllum leysinum úr sprautunni í hettuglasið með þurrefninu.
English: Severe humoral or cellular (primary or acquired) immunodeficiency, e.g., severe combined immunodeficiency, agammaglobulinemia and AIDS or symptomatic HIV infection or an age-specific
Icelandic: Alvarlegur vessa- eða frumubundinn (meðfæddur eða áunninn) ónæmisbrestur, t.d. alvarlegur samsettur ónæmisbrestur, gammaglóbúlínskortur og alnæmi eða HIV-sýking með einkennum eða aldurshópaháð CD4+ T-eitilfrumuhlutfall hjá börnum yngri en 12 mánaða:
English: Most cases of varicella reported in recipients of 1 dose or 2 doses of vaccine were mild.
Icelandic: Í flestum tilvikum sem greint var frá eftir 1 skammt eða 2 skammta, var um að ræða væga hlaupabólu.
English: ProQuad - Powder in vial and solvent in pre-filled syringe without needle - Pack of 1, 10, 20
Icelandic: ProQuad - Þurrefni í hettuglasi og leysir í áfylltri sprautu án nálar- pakkning með 1, 10 eða 20 hettuglösum
English: Febrile seizures
Icelandic: Varanleiki ónæmissvörunar
English: In addition, a decrease by approximately 90% (approximately 10-fold) in varicella hospitalization rates was observed in all age groups.
Icelandic: Auk þess fækkaði innlögnum á sjúkrahús sem nemur u.þ.b. 90% (u.þ.b. 10-falt) hjá öllum aldurshópum.
English: What ProQuad contains
Icelandic: ProQuad inniheldur
English: Sucrose, hydrolysed gelatin, urea, sodium chloride, sorbitol, monosodium glutamate, sodium phosphate, sodium bicarbonate, potassium phosphate, potassium chloride, medium 199 with Hanks' Salts, MEM, neomycin, phenol red, HCl, NaOH.
Icelandic: Súkrósi, vatnsrofin gelatína, þvagefni, natríumklóríð, sorbitól, einnatríumglútamat, natríumfosfat, natríumtvíkarbónat, kalíumfosfat, kalíumklóríð, medium 199 með Hankssöltum, MEM, neomycin, fenólrautt, HCl, NaOH.
English: Abdominal pain upper, Abnormal faeces, Constipation, Flatulence, Nausea, Salivation increase, Stomatitis, Teething
Icelandic: Verkur í efri hlut kviðar, óeðlilegar hægðir, hægðatregða, vindgangur, ógleði, aukin munnvatnsmyndun, munnbólga, tanntaka
English: • A side effect after vaccination with measles, mumps, or rubella (in a single vaccine or combined vaccine, such as the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. or ProQuad) that involved easy bruising or bleeding for longer than usual.
Icelandic: Aukaverkun eftir bólusetningu gegn mislingum, hettusótt eða rauðum hundum (sem einþátta bóluefni eða sem fjölþátta bóluefni, t.d. bóluefni gegn mislingum, hettusótt og rauðum hundum sem Merck & Co., Inc. framleiðir, eða ProQuad), ef aukaverkunin var á þá leið að marblettir komu auðveldlega fram eða að blæðing stóð óeðlilega lengi yfir.
English: Vascular disorders Flushing, Pallor
Icelandic: Meltingarfæri Niðurgangur, uppköst
English: 1 vial (powder) + 1 pre-filled syringe without needle (solvent).
Icelandic: 1 hettuglas (duft) + 1 áfyllt sprauta án nálar (leysir).
English: What you need to know before you receive ProQuad
Icelandic: Áður en þú færð ProQuad
English: In the infants with serological evidence of rubella infection, none had symptomatic disease.
Icelandic: Ekkert kornabarnanna, sem voru með mótefnatítra (serological evidence) sem bendir til að þau hafi fengið rauða hunda, fékk sjúkdóminn þannig að einkenni kæmu fram.
English: The vaccine may contain traces of recombinant human albumin (rHA).
Icelandic: Þetta bóluefni getur innihaldið snefilmagn af manna albúmíni, framleiddu með samrunaerfðatækni (rHA).
English: When completely mixed, the vaccine is a clear pale yellow to light pink liquid.
Icelandic: Þegar blöndun er lokið er bóluefnið tær, fölgulur til ljósbleikur vökvi.
English: 20 vials (powder) + 20 pre-filled syringes without needle (solvent).
Icelandic: 20 hettuglös (duft) + 20 áfylltar sprautur án nála (leysir).
English: In comparison, following ProQuad given concomitantly with Prevenar and/or hepatitis A vaccine in 3 clinical trials, the observed rates of reported fever (≥39.4°C rectal equivalent) ranged from 15.2% to 27.2%.
Icelandic: A bóluefni í þremur klínískum rannsóknum var tilkynnt tíðni hita (≥39,4°C skv. endaþarmsmælingu) á bilinu 15,2% til 27,2%.
English: The vaccine is a powder for suspension for injection contained in a single-dose vial, which should be mixed with solvent provided with the vial of powder.
Icelandic: Bóluefnið er stungulyfsstofn, dreifa í einskammta hettuglasi, sem leysa á upp með leysi sem fylgir hettuglasinu með þurrefninu.
English: Post-marketing experience with live measles, mumps, and rubella vaccine indicates that individuals with current thrombocytopenia may develop more severe thrombocytopenia following vaccination.
Icelandic: Reynslan eftir markaðssetningu með lifandi bóluefni gegn mislingum, hettusótt og rauðum hundum bendir til að einstaklingar sem eru með blóðflagnafæð fyrir kunni að fá alvarlegri blóðflagnafæð eftir bólusetningu.
English: High-risk individuals susceptible to varicella include:
Icelandic: Þeir sem eru í mikilli áhættu og eru næmir fyrir hlaupabólu, eru:
English: The most common adverse events reported with the use of ProQuad were: injection-site reactions including pain/tenderness/soreness, redness, swelling or bruising; fever (≥39.4°C rectal equivalent); irritability; rash (including measles-like rash, varicella-like rash, and injection-site rash); upper respiratory infection; vomiting and diarrhoea.
Icelandic: viðbrögð á stungustað, meðal annars verkur/viðkvæmni/eymsli, roði, bólga eða mar; hiti (≥39,4°C skv. endaþarmsmælingu); erting; útbrot (þar með talin útbrot sem líkjast mislingum, útbrot sem líkjast hlaupabólu og útbrot á stungustað); sýkingar í efri öndunarvegi; uppköst og niðurgangur.
English: Also, if the person to be vaccinated has already been exposed to the measles, mumps, rubella, or varicella virus but is not yet ill, ProQuad may not be able to prevent the illness from appearing.
Icelandic: Einnig er ekki víst að ProQuad geti komið í veg fyrir sjúkdóminn ef einstaklingurinn sem er bólusettur hefur þá þegar smitast af mislingum, hettusótt, rauðum hundum eða hlaupabólu en sjúkdómurinn er ekki enn kominn í ljós.
English: Erythema multiforme, Herpes simplex, Impetigo, Panniculitis, Purpura, Skin induration, StevensJohnson syndrome, Sunburn
Icelandic: Mjög sjaldgæfar húð, sár á húð, ristillík útbrot Regnbogasótt, áblásturssótt, kossageit, panninculitis, purpuri, hersli í húð, Stevens-Johnson heilkenni, sólbruni
English: Sucrose, hydrolysed gelatin, urea, sodium chloride, sorbitol, monosodium glutamate, sodium phosphate, sodium bicarbonate, potassium phosphate, potassium chloride, medium 199 with Hanks' Salts, MEM, neomycin, phenol red, hydrochloric acid and sodium hydroxide.
Icelandic: Súkrósi, vatnsrofin gelatína, þvagefni, natríumklóríð, sorbitól, einnatríumglútamat, natríumfosfat, natríumtvíkarbónat, kalíumfosfat, kalíumklóríð, medium 199 með Hankssöltum, MEM, neomycin, fenólrautt, saltsýra, natríumhýdroxíð.
English: 10 vials (powder) + 10 pre-filled syringes (solvent)+ 10 needles.
Icelandic: 10 hettuglös (duft) + 10 áfylltar sprautur (leysir) + 10 nálar.
English: ProQuad is a vaccine containing measles, mumps, rubella, and varicella (chickenpox) viruses that have been weakened.
Icelandic: ProQuad er bóluefni sem inniheldur veiklaðar mislinga-, hettusóttar-, rauðra hunda og hlaupabóluveirur.
English: 20 vials (powder) + 20 pre-filled syringes (solvent)+ 40 needles.
Icelandic: 20 hettuglös (duft) + 20 áfylltar sprautur (leysir) + 40 nálar.
English: EU/1/05/323/010 - pack of 1 EU/1/05/323/011 - pack of 10 EU/1/05/323/013 - pack of 20
Icelandic: EU/1/05/323/010 - pakkning með 1 hettuglasi EU/1/05/323/011 - pakkning með 10 hettuglösum EU/1/05/323/013- pakkning með 20 hettuglösum
English: ProQuad is available in pack of 1, 10 and 20.
Icelandic: ProQuad er fáanlegt í 1, 10 eða 20 stk. pakkningum, með eða án nálar.
English: ProQuad - Powder in vial and solvent in pre-filled syringe with attached needle - Pack of 1, 10
Icelandic: ProQuad - Þurrefni í hettuglasi og leysir í áfylltri sprautu með nál - pakkning með 1 eða 10 hettuglösum
English: Children who received ProQuad at 4 through 6 years of age after primary immunization with Varicella Vaccine live (Oka/Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc.
Icelandic: ProQuad 4 til 6 ára gömul, eftir grunnbólusetningu með lifandi bóluefni við hlaupabólu (Oka/Merck) og bóluefni gegn mislingum, hettusótt og rauðum hundum sem Merck & Co., Inc. framleiðir
English: 1 vial (powder) + 1 pre-filled syringe (solvent)+ 1 needle.
Icelandic: 1 hettuglas (duft) + 1 áfyllt sprauta (leysir) + 1 nál.
English: Dehydration
Icelandic: LYFJAFORM
English: ProQuad elicits rates of antibody responses against measles, mumps, and rubella similar to those observed after vaccination with the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc.
Icelandic: ProQuad veldur mótefnasvörun gegn mislingum, hettusótt og rauðum hundum í svipuðum mæli og sést eftir bólusetningu með bóluefni gegn mislingum, hettusótt og rauðum hundum, sem Merck & Co., Inc. framleiðir.
English: The immunogenicity of the current refrigerator-stable formulation was shown to be similar to the immunogenicity of the earlier formulation of ProQuad six weeks after a single dose of the vaccine.
Icelandic: Ónæmingargetan 6 vikum eftir stakan skammt af nýju samsetningunni sem er stöðug í kæli (current refrigerator-stable formulation) var svipuð ónæmingargetu fyrir eldri samsetninguna af Proquad.
English: ProQuad may be used as the second dose in individuals who have previously received measles, mumps, and rubella vaccine and varicella vaccine.
Icelandic: Nota má ProQuad sem annan skammt, handa börnum sem hafa áður fengið bóluefni gegn mislingum, hettusótt og rauðum hundum, sem og bóluefni gegn hlaupabólu.
English: Withdraw the entire volume of solvent into a syringe.
Icelandic: Dragið allan leysinn úr hettuglasinu upp í sprautu.
English: 20 vials (powder) + 20 pre-filled syringes (solvent)+ 20 needles.
Icelandic: 20 hettuglös (duft) + 20 áfylltar sprautur (leysir) + 20 nálar.
English: 10 vials (powder) + 10 pre-filled syringes without needle (solvent).
Icelandic: 10 hettuglös (duft) + 10 áfylltar sprautur án nála (leysir).
English: EU/1/05/323/005 - pack of 1 EU/1/05/323/006 - pack of 10 EU/1/05/323/007 - pack of 20
Icelandic: EU/1/05/323/005 - pakkning með 1 hettuglasi EU/1/05/323/006 - pakkning með 10 hettuglösum EU/1/05/323/007 - pakkning með 20 hettuglösum
English: • If the person to be vaccinated has any illness with fever higher than 38.5°C; however, lowgrade fever itself is not a reason to delay vaccination.
Icelandic: Ef einstaklingurinn sem á að bólusetja er veikur og með meira en 38,5°C hita.
English: ProQuad contains sorbitol
Icelandic: ProQuad inniheldur sorbitól
English: Consequently, transmission through close personal contact, while accepted as a theoretical possibility, is not regarded as a significant risk; however, transmission of the rubella vaccine virus to infants via breast milk has been documented without any evidence of clinical disease (see section 4.6).
Icelandic: Hins vegar hefur verið greint frá smiti rauðra hunda veiru með brjóstamjólk til kornabarna, án nokkurra einkenna um klínískan sjúkdóm (sjá kafla 4.6).
English: VIAL OF POWDER
Icelandic: Heyrnarleysi frá taug
English: Sorbitol
Icelandic: Mislingaveira
English: Encephalitis and encephalopathy
Icelandic: Áverkar og eitranir
English: Influenza-like illness, Injection-site desquamation, Injection-site discolouration, Injection-site pruritus, Injection-site rash non-specific, Injection-site reaction, Injection-site scar, Hyperthermia, Pain
Icelandic: Inflúensulíkur sjúkdómur, hreistrun á stungustað, aflitun á stungustað, kláði á stungustað, ótilgreind útbrot á stungustað, viðbrögð á stungustað, ör á stungustað, ofurhiti, verkur
English: EU/1/05/323/008 - pack of 1 EU/1/05/323/009 - pack of 10 EU/1/05/323/012 - pack of 20
Icelandic: EU/1/05/323/008 - pakkning með 1 áfylltri sprautu EU/1/05/323/009 - pakkning með 10 áfylltum sprautum EU/1/05/323/012 - pakkning með 20 áfylltum sprautum
English: Ataxia, Convulsion, Headache, High-pitched crying, Hyperkinesia, Hypersomnia, Lethargy, Tremor
Icelandic: Hreyfiglöp, krampar, höfuðverkur, hár grátur, sjúkleg hreyfingarþörf, svefnsækni, þreyta, skjálfti
English: Lymphadenitis, Regional lymphadenopathy, Thrombocytopenia
Icelandic: ProQuad stungulyfsstofn, dreifa i.m./s.c.
English: If you or your child get any side effects, talk to your doctor or pharmacist.
Icelandic: Látið lækninn eða lyfjafræðing vita um allar aukaverkanir hjá þér eða barninu.
English: 10 vials (powder) + 10 pre-filled syringes (solvent)+ 20 needles.
Icelandic: 10 hettuglös (duft) + 10 áfylltar sprautur (leysir) + 20 nálar.
English: EU/1/05/323/003 - pack of 1 EU/1/05/323/004 - pack of 10
Icelandic: EU/1/05/323/003 - pakkning með 1 hettuglasi EU/1/05/323/004 - pakkning með 10 hettuglösum
English: Postdose 1 Postdose 2
Icelandic: 1 Eftir skammt
English: Bronchiolitis, Candida nappy rash, Candidiasis, Cellulitis, Infectious croup, Viral gastroenteritis, Hand-foot-mouth disease, Influenza, Pseudocroup, Respiratory infection, Skin infection, Tonsillitis, Varicella
Icelandic: Berkjungabólga, hvítsveppa bleiuútbrot, hvítsveppasýking, netjubólga, smitandi kvashósti, maga- og garnabólga af völdum veiru, hand-, fót- og munnsjúkdómur, inflúensa, sogakvef, sýking í öndunarfærum, sýking í húð, eitlabólga, hlaupabóla tárubólga af völdum veiru
English: ProQuad powder and solvent for suspension for injection ProQuad powder and solvent for suspension for injection in a pre-filled syringe
Icelandic: ProQuad stungulyfsstofn og leysir, dreifa ProQuad stungulyfsstofn og leysir, dreifa í áfylltri sprautu
English: EU/1/05/323/001 - pack of 1 EU/1/05/323/002 - pack of 10
Icelandic: EU/1/05/323/001 - pakkning með 1 hettuglasi EU/1/05/323/002 - pakkning með 10 hettuglösum
English: Respiratory, thoracic, and mediastinal disorders Cough, Nasal congestion, Respiratory congestion, Rhinorrhoea
Icelandic: Öndunarfæri, brjósthol og miðmæti Hósti, nefstífla, stífla í öndunarfærum, nefrennsli
English: In addition, individuals who experienced thrombocytopenia following the first dose of a live measles, mumps, and rubella vaccine may develop thrombocytopenia with repeat doses.
Icelandic: Þar að auki kunna einstaklingar sem fengu blóðflagnafæð eftir fyrsta skammt af lifandi bóluefni gegn mislingum, hettusótt og rauðum hundum að fá blóðflagnafæð við endurtekna skammta.
English: Thrombocytopenia
Icelandic: Kalíumfosfat
English: Complications of varicella from vaccine strain including herpes zoster and disseminated disesase such as aseptic meningitis and encephalitis have been reported in immunocompromised or immunocompetent individuals.
Icelandic: Greint hefur verið frá fylgikvillum hlaupabólu af völdum bóluefnis þ.m.t. ristli og dreifðum sjúkdómum eins og heilahimnubólgu án sýkingar og heilabólgu hjá ónæmisbældum einstaklingum eða þeim sem eru með heilbrigt ónæmiskerfi.
English: 10 vials (powder) + 10 pre-filled syringes with needle (solvent).
Icelandic: 10 hettuglös (duft) + 10 áfylltar sprautur með nál (leysir).
English: • pregnant women without documented positive history of varicella (chickenpox) or laboratory evidence of prior infection,
Icelandic: Þungaðar konur, án skjalfestrar sögu um hlaupabólu eða rannsóknarniðurstöður sem staðfesta fyrri sýkingu.
English: When a person is given the vaccine, the immune system (the body's natural defences) will make antibodies against the measles, mumps, rubella, and varicella viruses.
Icelandic: Við bólusetningu myndar ónæmiskerfið (eigin varnir líkamans) mótefni gegn mislinga-, hettusóttar-, rauðra hunda og hlaupabóluveirum.
English: 1 vial (powder) + 1 pre-filled syringe with needle (solvent).
Icelandic: 1 hettuglas (duft) + 1 áfyllt sprauta með nál (leysir).
English: Extravasation
Icelandic: Aukaverkanir
English: Arthralgia and/or arthritis
Icelandic: Liðverkir og/eða liðbólga
English: Vaccination with ProQuad may not result in protection in all vaccine recipients.
Icelandic: Ekki er víst að ProQuad veiti vörn hjá öllum sem eru bólusettir.
English: Phenol red
Icelandic: Pike West Point
English: 10 vials (powder) + 10 vials (solvent).
Icelandic: 10 hettuglös (duft) + 10 hettuglös (leysir).
English: 3 Oka/Merck strain (live, attenuated) ................... not less than 3.99 log10 PFU**
Icelandic: CCID50 Hlaupabóluveira Oka/Merck stofn .......................................................≥ 3,99 log10
English: 1 Jeryl Lynn™ (Level B) strain (live, attenuated)...not less than 4.30 log10 CCID50* Rubella virus
Icelandic: CCID50 Hettusóttarveira Jeryl Lynn™ (Level B) stofn.
English: Blood and the lymphatic system disorders Leukocytosis, Lymphadenopathy
Icelandic: Blóð og eitlar Hvítfrumnafjölgun, eitlastækkun
English: Atypical measles, Encephalitis*, Epididymitis, Herpes zoster*, Infection, Measles, Orchitis, Parotitis
Icelandic: Heilahimnubólga án sýkingar*, óvenjulegir mislingar, heilabólga*, lyppubólga, ristill*, sýking, mislingar, eistnabólga, vangakirtilsbólga
English: Bronchial spasm, Bronchitis, Epistaxis, Pneumonitis (see section 4.3), Pneumonia, Pulmonary congestion, Rhinitis, Sinusitis, Sore throat
Icelandic: Astmi, lungnateppa, skútakvilli, hnerri, önghljóð Mjög sjaldgæfar Berkjukrampar, berkjubólga, blóðnasir, millivefsbjúgbólga lungna (sjá kafla 4.3), lungnabólga, lungnateppa, nefkvef, skútabólga, særindi í hálsi
English: Pregnancy.
Icelandic: Þvagefni
English: General disorders and administration site conditions Fever
Icelandic: Almennar aukaverkanir og aukaverkanir á íkomustað Hiti
English: Measles virus Enders' Edmonston strain .....................................≥ 3.00 log10 CCID50 Mumps virus Jeryl Lynn™ (Level B) strain ................................≥ 4.30 log10 CCID50 Rubella virus Wistar RA 27/3 strain............................................≥ 3.00 log10 CCID50 Varicella virus Oka/Merck strain.................................................≥ 3.99 log10 PFU
Icelandic: CCID50 Rauðra hunda veira Wistar RA 27/3 stofn ...........................................≥ 3,00 log10
English: • If the person to be vaccinated has active untreated tuberculosis.
Icelandic: Ef einstaklingurinn sem á að bólusetja er með virka, ómeðhöndlaða berkla.
English: The only vaccine related injection-site adverse reaction that was more frequent among recipients of ProQuad than among recipients of Varicella Vaccine live (Oka/Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & Co. Inc. was rash at the injection site.
Icelandic: ProQuad en hjá þeim sem fengu lifandi bóluefni við hlaupabólu (Oka/Merck) og bóluefni gegn mislingum, hettusótt og rauðum hundum sem Merck & Co., Inc. framleiðir, var útbrot á stungustað.
English: ‡, Rash, Varicella-like rash
Icelandic: Mar, óeitrað bit/stingur
English: 1 Enders' Edmonston strain (live, attenuated)........ not less than 3.00 log10 CCID50*
Icelandic: Mislingaveira Enders Edmonston stofn ...............................................≥ 3,00 log10
English: • Rare: skin infection; varicella (chickenpox).
Icelandic: Mjög sjaldgæfar: húðsýking; hlaupabóla.
English: Asthenia/fatigue, Injection-site haemorrhage, Injection-site induration or warmth, Injection-site mass, Malaise
Icelandic: Þróttleysi/þreyta, blæðing á stungustað, hersli eða hiti á stungustað, massi á stungustað, lasleiki
English: The vaccine should be administered subcutaneously in patients with thrombocytopenia or any coagulation disorder.
Icelandic: Gefa á bóluefnið undir húð hjá sjúklingum með blóðflagnafæð eða aðra blóðstorkuröskun.
English: 1 vial (powder) + 1 vial (solvent).
Icelandic: 1 hettuglas (duft) + 1 hettuglas (leysir).
English: Conjunctivitis, Eye discharge, Eyelid inflammation, Eye irritation, Eye swelling, Ocular hyperaemia, Tearing, Visual discomfort
Icelandic: Tárubólga, útferð úr auga, bólga í augnloki, erting í auga, augnþroti, blóðsókn í auga, táramyndun, sjónræn óþægindi
English: Musculoskeletal, connective tissue and bone disorders Arm pain, Musculoskeletal stiffness
Icelandic: Kviðverkur, blóðhægðir, sár í munni