FrancophonIA/ELRC3.0 huggingface dataset:
English: At 1 year post last vaccination, the percentages of subjects with hSBA ≥1:8 after the 2-dose series and the single dose were both lower than at 1 month post-vaccination (30% after the 2-dose series, 11%20% after the single dose for serogroup A; 61%-81% and 41%-55% for serogroup C; 92%-94% and 90%-91% for serogroup W-135; 67%-75% and 57%-65% for serogroup Y).
Icelandic: Einu ári eftir síðustu bólusetningu var hlutfall þátttakenda með hSBA ≥1:8 eftir bæði tveggja skammta röð og stakan skammt lægra en það var einum mánuði eftir bólusetningu (30% eftir tveggja skammta röð, 11%-20% eftir einn skammt fyrir sermihóp A; 61%-81% og 41%-55% fyrir sermihóp C; 92%94% og 90%-91% fyrir sermihóp W-135; 67%-75% og 57%-65% fyrir sermihóp Y).
English: Not for intravascular, subcutaneous or intradermal injection.
Icelandic: Ekki til notkunar í æð, í eða undir húð.
English: Table 4: Serum bactericidal antibody responses following Menveo one month after vaccination among subjects aged 11-18 years
Icelandic: Bakteríudrepandi mótefnasvörun í sermi eftir bólusetningu með Menveo einum mánuði eftir bólusetningu hjá einstaklingum á aldrinum 11-18 ára
English: In the children 2-10 years of age, as well as in each age strata (2-5 and 6-10 years), immune response as measured by percentage of subjects with seroresponse, hSBA≥1:8 and GMTs were not only non-inferior to comparator vaccine ACWY-PS, but all were statistically higher than the comparator for all serogroups and all immune measurements at 1 month post vaccination.
Icelandic: Hjá 2-10 ára börnunum og hjá hvorum aldursflokki (2-5 og 6-10 ára), var ónæmissvörum, mæld sem hlutfall einstaklinga með sermissvörun, hSBA≥1:8 og hSBA margfeldismeðaltöl, ekki aðeins ekki lakari (non-inferior) en hjá samanburðarbóluefninu
English: In the event of any foreign particulate matter and/or variation of physical aspect being observed, discard the vaccine.
Icelandic: Ef agnir sjást og/eða bóluefnið hefur annað útlit skal farga því.
English: In the adolescent age group, the safety and tolerability of the vaccine was favourable relative to Tdap and did not substantially change with concomitant or sequential administration of other vaccines.
Icelandic: öryggi við notkun bóluefnisins meira og það þoldist betur en Tdap bóluefni og engar verulegar breytingar komu fram við samtímis gjöf annarra bóluefna eða gjöf þeirra hvers á eftir öðru.
English: Menveo powder and solution for solution for injection Meningococcal Group A, C, W-135 and Y conjugate vaccine
Icelandic: Menveo stungulyfsstofn og lausn fyrir stungulyf, lausn Samtengt bóluefni gegn meningókokkum af sermisgerðum A, C, W-135 og Y
English: Y. At 1 month post last vaccination, the percentages of subjects with hSBA ≥1:8 in the 2-dose group and in the single dose group across the two age strata were: 90%-95% vs 76%-80% for serogroup A, 98%-99% vs 76%-87% for serogroup C, 99% vs 93%-96% for serogroup W-135, and 96% vs 65%69% for serogroup Y. GMTs were higher in the 2-dose group than the single dose group at 1 month after vaccination in both age strata; however, this difference was less pronounced in the older age stratum.
Icelandic: 90%-95% á móti 76%-80% fyrir sermihóp A, 98%-99% á móti 76%-87% fyrir sermihóp C, 99% á móti 93%-96% fyrir sermihóp W-135 og 96% á móti 65%-69% fyrir sermihóp Y. GMT (margfeldismeðaltöl styrks) voru hærri í tveggja skammta hópnum en í hópnum sem fékk einn skammt, einum mánuði eftir bólusetningu í báðum aldurshópum; þessi munur var þó minna áberandi í eldri aldurshópnum.
English: hSBA GMTs (95% CI)
Icelandic: hSBA margfeldismeðaltöl (95% CI)
English: Table 9: Serum bactericidal antibody responses following Menveo one month after vaccination among subjects aged 19-55 years
Icelandic: Bakteríudrepandi mótefnasvörun í sermi við Menveo einum mánuði eftir bólusetningu hjá einstaklingum 19-55 ára
English: Meningococcal group W-135 oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 3.3-8.3 micrograms
Icelandic: Fásykra meningókokka af sermisgerð W-135 5 míkrógrömm samtengt við Corynebacterium diphtheriae CRM197 prótein 3,3-8,3 míkrógrömm
English: Table 7: Persistence of immune responses approximately 12 months and 5 years after vaccination with Menveo and ACWY-PS (subjects were aged 11-18 years at the time of vaccination)
Icelandic: Varanleiki ónæmissvörunar um 12 mánuðum og 5 árum eftir bólusetningu með Menveo og ACWY-PS (hjá einstaklingum sem voru á aldrinum 11-18 ára við bólusetninguna).
English: Persistence of immune response and booster response in children 2 to 10 years of age Antibody persistence at 5 years after primary vaccination was assessed in study V59P20E1, this was an extension of study V59P20.
Icelandic: Varanleiki mótefna 5 árum eftir frumbólusetningu var metinn í rannsókn V59P20E1 sem var framhald af rannsókn V59P20.
English: One dose consists of 1 vial of MenA Lyophilised Conjugate Component to be reconstituted with 1 vial of MenCWY Liquid Conjugate Component.
Icelandic: Einn skammtur samanstendur af 1 hettuglasi með frostþurrkuðum samtengdum MenA bóluefnisþætti sem blandað er með 1 hettuglasi með fljótandi samtengdum MenCWY bóluefnisþætti.
English: 6.6 Special precautions for disposal and other handling Menveo must be prepared for administration by reconstituting powder (in vial) with solution (in vial).
Icelandic: Menveo verður að undirbúa fyrir lyfjagjöf með því að blanda saman stofninum (í hettuglasinu) og lausninni (í hettuglasinu).
English: At 7 days post vaccination, 64% of subjects achieved hSBA ≥1:8 against serogroup A and 88% through 90% of subjects had bactericidal antibodies against serogroups C, W-135 and Y. At one month post vaccination, 92% through 98% of subjects had hSBA ≥1:8 against serogroups A, C, W-135 and Y. A robust immune response as measured by hSBA GMTs against all serogroups was also observed at 7 days (GMTs 34 through 70) and 28 days (GMTs 79 through 127) after a single dose vaccination.
Icelandic: 7 dögum eftir bólusetningu höfðu 64% einstaklinga náð hSBA ≥ 1:8 gegn sermishópi A og 88% til 90% einstaklinga höfðu myndað bakteríudrepandi mótefni gegn sermishópum C, W-135 og Y. Einum mánuði eftir bólusetningu höfðu 92% til 98% einstaklinga hSBA ≥ 1:8 gegn sermishópum A, C, W-135 og Y. Öflug mótefnasvörun, mæld sem hSBA margfeldismeðaltöl gegn öllum sermishópum, kom einnig fram eftir 7 daga (margfeldismeðaltöl 34 til 70) og 28 daga (margfeldismeðaltöl 79 til 127) eftir eina bólusetningu.
English: Serog roup
Icelandic: Sermis-hópur
English: Time point
Icelandic: Tímapun ktur
English: A booster dose of Menveo was administered 5 years after primary vaccination with Menveo or ACWY-PS. At 7 days after the booster dose, 98%-100% of subjects who previously received Menveo and 73%-84% of subjects who previously received ACWY-PS achieved hSBA ≥1:8 against serogroups A, C, W-135 and Y. At one month post vaccination, the percentages of subjects with hSBA≥1:8 were 98%-100% and 84%-96%, respectively.
Icelandic: 7 dögum eftir að örvunarskammtur var gefinn reyndust 98%-100% einstaklinga sem höfðu áður fengið Menveo og 73%-84% einstaklinga sem höfðu áður fengið ACWY-PS hafa náð hSBA ≥ 1:8 gegn sermishópum A, C, W-135 og Y. Einum mánuði eftir bólusetningu var hlutfall einstaklinga með hSBA≥ 1:8 annars vegar 98%-100% og hins vegar 84%-96%.
English: Meningococcal group A oligosaccharides 10 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 16.7-33.3 micrograms
Icelandic: Fásykra meningókokka af sermisgerð A 10 míkrógrömm samtengt við Corynebacterium diphtheriae CRM197 prótein 16,7-33,3 míkrógrömm
English: Table 5: Immunogenicity of one dose of Menveo or ACWY-PS in adolescents, measured at one month post vaccination
Icelandic: Ónæmingargeta eins skammts af Menveo eða ACWY-PS hjá unglingum, mælt einum mánuði eftir bólusetningu
English: ACWY-PS for all four serogroups and statistically superior for serogroups A and Y (Table 10).
Icelandic: Hlutfall einstaklinga með hSBA ≥ 1:8 var ekki lakari miðað við ACWY-PS fyrir allar fjórar sermisgerðir og tölfræðilega hærra fyrir sermisgerð A og Y (tafla 10).
English: GlaxoSmithKline, S.A. Tel: + 34 900 202 700 es-ci@gsk.com
Icelandic: + 34 900 202 700 es-ci@gsk.com
English: Individuals with complement deficiencies and individuals with functional or anatomical asplenia may not mount an immune response to meningococcal group A, C, W-135 and Y conjugate vaccines.
Icelandic: Verið getur að einstaklingar með komplementskort og þeir sem eru án milta eða með vanvirkt milta myndi ekki ónæmi með samtengdu bóluefni gegn meningókokkum af sermisgerð A, C, W-135 og Y.
English: Timepoint
Icelandic: Sermishópur Tímapunktur
English: There was antibody persistence observed against serogroups C, W-135
Icelandic: Fásykra meningókokka af sermisgerð W-135
English: Common: arthralgia
Icelandic: Algengar: liðverkir
English: Results are presented in Table 9.
Icelandic: Niðurstöðurnar eru í töflu
English: It cannot protect against other types of meningococcal bacteria other than groups A, C, W-135 and Y, or against other causes of meningitis and sepsis (blood poisoning).
Icelandic: Þetta bóluefni getur aðeins veitt vörn gegn meningókokkum af sermisgerðum A, C, W-135 og Y. Það veitir ekki vörn gegn öðrum tegundum meningókokka en af gerðum A, C, W-135 og Y eða gegn öðrum sjúkdómsvöldum heilahimnubólgu eða blóðsýkingar.
English: The risk-benefit ratio for persons at risk of haematoma following intramuscular injection must be evaluated by health care professionals.
Icelandic: Heilbrigðisstarfsfólk verður að meta hlutfall áhættu og ávinnings hjá þeim seim eiga á hættu að fá margúl eftir inndælingu í vöðva.
English: • Periodic Safety Update Reports
Icelandic: Upplýsingar um öryggi
English: and Y, with the percentages of subjects with hSBA ≥ 1:8 being 32% and 56% against serogroup C in subjects 2-5 and 6-10 years of age, respectively, 74% and 80% against serogroup W-135, and 48% and 53% against serogroup Y. GMTs were respectively 6.5 and 12 for serogroup C, 19 and 26 for serogroup W-135, and 8.13 and 10 for serogroup Y. For serogroup A, 14% and 22% of subjects 2-5
Icelandic: 2-5 ára var 32% og 56% hjá 6-10 ára gegn sermishópi C, hlutföllin hjá þessum aldurshópum gegn sermishópi W-135 voru annars vegar 74% og hins vegar 80% og 48% og 53% gegn sermishópi Y. Margfeldismeðaltölin voru annars vegar 6,5 og hins vegar 12 fyrir sermishóp C, 19 og 26 fyrir sermishóp W-135 og 8,13 og 10 fyrir sermishóp Y.
English: In 5 years post vaccination, the percentage of Menveo recipients with hSBA ≥ 1:8 remained significantly higher compared with ACWY-PS recipients for serogroups C and Y. Higher hSBA GMTs were observed for serogroups W-135 and Y (Table 7).
Icelandic: Í 5 ár eftir bólusetningu hélst hlutfall einstaklinga sem fengu Menveo og höfðu hSBA ≥ 1:8 umtalsvert hærra, samanborið við þá sem fengu ACWY-PS fyrir sermishópa C og Y. Hærri hSBA margfeldismeðaltöl komu fram fyrir sermishópa W-135 og Y (tafla 7).
English: No effects on fertility were observed in female rabbits receiving Menveo pre-mating and during pregnancy.
Icelandic: Engin áhrif á frjósemi komu fram hjá kvenkanínum sem fengu
English: Meningococcal group C oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 7.1-12.5 micrograms
Icelandic: Fásykra meningókokka af sermisgerð 5 míkrógrömm samtengt við Corynebacterium diphtheriae CRM197 prótein 7,1-12,5 míkrógrömm
English: Meningococcal group Y oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 5.6-10.0 micrograms.
Icelandic: Fásykra meningókokka af sermisgerð Y 5 míkrógrömm samtengt við Corynebacterium diphtheriae CRM197 prótein 5,6-10,0 míkrógrömm
English: There are no data on the applicability of the vaccine for post-exposure prophylaxis.
Icelandic: Engin gögn eru til um notkun bóluefnisins til sjúkdómsvarnar eftir að viðkomandi hefur komist í snertingu við sjúkdóminn.
English: Timepo int
Icelandic: VIÐAUKI II
English: The clinical relevance of higher post-vaccination immune responses is not known.
Icelandic: Klínískt mikilvægi hærri ónæmissvörunar eftir bólusetningu er óþekkt.
English: GMT (95% CI)
Icelandic: hSBA (95% CI)
English: Frequencies are defined as follows:
Icelandic: Tíðni er skilgreind með eftirfarandi hætti:
English: Common: injection site erythema (>50 mm), injection site induration (>50 mm), fever ≥38°C, chills Uncommon: injection site pruritus
Icelandic: Algengar: bólga við íkomustað (>50 mm), hersli við íkomustað (>50 mm), hiti ≥38°C, hrollur Sjaldgæfar: kláði við íkomustað
English: Contents of the pack and other information What Menveo contains
Icelandic: Hugsanlegar aukaverkanir Hvernig geyma á Menveo Pakkningar og aðrar upplýsingar
English: Gastrointestinal disorders:
Icelandic: Blöndun bóluefnisins:
English: GlaxoSmithKline S.p.A. Tel: +39 (0)45 9218 111
Icelandic: ГлаксоСмитКлайн ЕООД Тел. + 359 2 953 10 34
English: The need for and timing of a booster dose in subjects previously vaccinated with Menveo is to be defined based on national recommendations.
Icelandic: örvunarskammts fyrir einstaklinga sem hafa áður verið bólusettir með Menveo á grundvelli ráðlegginga sem gefnar eru í hverju landi.
English: At one year post vaccination in these same subjects, compared with ACWY-PS, a higher proportion of subjects vaccinated with Menveo had hSBA ≥1:8 for serogroups C, W-135, and Y, with comparable levels for serogroup A. Similar findings were observed in the comparison of hSBA GMTs.
Icelandic: Þegar skoðaðir voru sömu einstaklingar einu ári eftir bólusetningu, í samanburði við þá sem fengu ACWY-PS, var hærra hlutfall þeirra sem voru bólusettir með Menveo með hSBA ≥1:8 fyrir sermisgerðir C, W-135 og Y, en með svipaðan styrk fyrir sermisgerð A.
English: ACWY
Icelandic: Stofn
English: The contents of the two components (vial and vial) are to be mixed prior to vaccination providing 1 dose of 0.5 ml.
Icelandic: Innihaldi beggja bóluefnisþáttanna (hettuglas og hettuglas) á að blanda áður en bólusett er þannig að fáist einn skammtur með 0,5 ml.
English: Menveo contains
Icelandic: Menveo inniheldur
English: Each dose of Menveo is supplied as a: - 1 Vial containing the MenA Lyophilised Conjugate Component as a white to off-white powder - 1 Vial containing the MenCWY Liquid Conjugate Component as clear solution - Pack size of one dose (2 vials) or five doses (10 vials).
Icelandic: - 1 hettuglas með MenA frostþurrkuðum samtengdum bóluefnisþætti sem hvítt til beinhvítt duft - 1 hettuglas með MenCWY fljótandi samtengdum bóluefnisþætti sem tær lausn
English: Marketing Authorisation Holder: GSK Vaccines S.r.l., Via Fiorentina 1, 53100 Siena, Italy
Icelandic: GSK Vaccines S.r.l., Via Fiorentina
English: Serogroup hSBA ≥1:8
Icelandic: Sermishópur hSBA ≥1:8
English: 12 months post-vaccination hSBA ≥1:8
Icelandic: 12 mánuðum eftir bólusetningu hSBA ≥1:8
English: While Human Immunodeficiency Virus (HIV) infection is not a contraindication, Menveo has not been specifically evaluated in immunocompromised people.
Icelandic: Þótt HIV-smit sé ekki frábending hefur
English: In the powder: potassium dihydrogen phosphate and sucrose.
Icelandic: Í stofninum: kalíumtvíhýdrógenfosfat og súkrósi.
English: Very common: myalgia
Icelandic: Sjaldgæfar: sundl
English: GlaxoSmithKline GmbH & Co. KG Tel: +49 (0)89 36044 8701 de.impfservice@gsk.com
Icelandic: +49 (0)89 36044 8701 de.impfservice@gsk.com
English: hSBA ≥ 1:8 (95% CI)
Icelandic: hSBA (95% C I)
English: It must not be administered intravascularly, subcutaneously or intradermally.
Icelandic: Það má ekki gefa í æð, undir húð eða í húð.
English: Very common: headache, nausea, injection site pain, injection site redness (≤ 50 mm), injection site firmness (≤ 50 mm), muscle ache, generally feeling unwell
Icelandic: Höfuðverkur, ógleði, verkur á stungustað, roði á stungustað (≤50 mm), hersli á stungustað (≤50 mm), vöðvaverkir, almenn vanlíðan Algengar: Útbrot, roði á stungustað (>50 mm), hersli á stungustað (>50 mm), liðverkir, hiti ≥38°C, hrollur
English: Very common: irritability, malaise, injection site pain, injection site erythema (≤50 mm), injection site induration (≤50 mm)
Icelandic: Mjög algengar: skapstyggð, lasleiki, verkur á stungustað, roði á stungustað (≤50 mm), hersli á stungustað (≤50 mm)
English: 5 year persistence 1 month after booster hSBA
Icelandic: Varanleiki í 5 ár 1 mánuði eftir örvunarskammt hSBA (95% C I)
English: W-135 N=96 N=96 N=95 N=95 N=64 N=64 N=60 N=60
Icelandic: N=96 N=96 N=95 N=95 N=64 N=64 N=60 N=60
English: General disorders and administration site conditions Not known: injection site cellulitis, injection site swelling, including extensive swelling of the injected limb
Icelandic: Almennar aukaverkanir og aukaverkanir á íkomustað Tíðni ekki þekkt: húðbeðsbólga á stungustað, bólga á stungustað, þ.m.t. umfangsmikil bólga í útlim sem dælt var í
English: At 1 year post vaccination, Menveo continued to be statistically higher than ACWY-PS for serogroups A, W-135 and Y, as measured by percentage of subjects with hSBA≥1:8 and GMTs.
Icelandic: Sýnt var fram á að Menveo væri ekki lakara en ACWY-PS bóluefnið hvað varðar allar fjórar sermisgerðirnar (A, C, W-135 og Y) á grundvelli sermissvörunar, hlutfalli þeirra sem náðu hSBA ≥1:8 og margfeldismeðaltala (GMT).
English: At 5 years after primary vaccination, there were significantly higher percentages of subjects with hSBA ≥ 1:8 in the Menveo group than in the vaccine-naive control subjects against all the four serogroups.
Icelandic: 5 árum eftir frumbólusetningu greindist umtalsvert hærra hlutfall einstaklinga með hSBA ≥ 1:8 í hópnum sem fékk
English: General disorders and administration site conditions:
Icelandic: Almennar aukaverkanir og ástand tengt íkomustað:
English: Serogrou p
Icelandic: Sermi shópu r
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Icelandic: Upplýsingar sem hægt er að nálgast annars staðar Ítarlegar upplýsingar um lyfið eru birtar á vef Lyfjastofnunar Evrópu: http://www.ema.europa.eu Upplýsingar á íslensku eru á http://www.serlyfjaskra.is Þessi fylgiseðill er birtur á vef Lyfjastofnunar Evrópu á tungumálum allra ríkja Evrópska efnahagssvæðisins.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - POWDER IN VIAL AND SOLUTION IN VIAL
Icelandic: YTRI UMBÚÐUM ASKJA- STOFN Í HETTUGLASI OG LAUSN Í HETTUGLASI
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL MENA LYOPHILISED CONJUGATE COMPONENT
Icelandic: MERKIMIÐI Á HETTUGLASI MENCWY FLJÓTANDI BLANDAÐUR BÓLUEFNISÞÁTTUR
English: Not known: tonic convulsion, febrile convulsion, syncope Ear and labyrinth disorders
Icelandic: Tíðni ekki þekkt: ofnæmi, þ.m.t. bráðaofnæmi
English: Uncommon: dizziness
Icelandic: Algengar: útbrot
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (0.5 ml of the reconstituted vaccine) contains: (Originally contained in the powder)
Icelandic: Einn skammtur (0,5 ml af blönduðu bóluefni) inniheldur:
English: Common: injection site erythema (>50mm), injection site induration (>50mm), chills, fever ≥38oC
Icelandic: Algengar: roði á stungustað (>50 mm), hersli á stungustað (>50 mm), hrollur, hiti ≥38°C Sjaldgæfar: kláði á stungustað
English: Common (may affect up to 1 in 10 people): change in eating habits, nausea, vomiting, diarrhea, rash, muscle ache, joint ache, chills, fever ≥38oC, injection site redness (>50mm) and injection site firmness (>50mm)
Icelandic: niðurgangur, útbrot, vöðvaverkir, liðverkir, hrollur, hiti ≥38°C, roði á stungustað (>50 mm) og hersli á stungustað (>50 mm)
English: In the non-inferiority study, V59P6, immunogenicity was assessed among adolescents aged 11-17 years who had been randomised to receive either Menveo or ACWY-PS. Menveo was shown to be non-inferior to ACWY-PS vaccine for all four serogroups (A, C, W-135 and Y) based on seroresponse, proportions achieving hSBA ≥1:8, and GMTs.
Icelandic: Í rannsókn á því hvort bóluefnið væri lakara (non-inferiority study), V59P6, var ónæmingargeta metin meðal unglinga á aldrinum 11-17 ára sem voru slembivaldir til að fá annaðhvort Menveo eða ACWY-PS.
English: Powder
Icelandic: Ónæmingargeta
English: Menveo ACWY-P S
Icelandic: Menveo gegn ACWY -PS
English: Please tell your doctor if you have received a previous injection with Menveo or another meningococcal vaccine.
Icelandic: Menveo eða annað meningókokkalbóluefni með inndælingu.
English: MenA Conjugate
Icelandic: Tilkynning aukaverkana
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Menveo solution for injection
Icelandic: AÐFERÐ VIÐ LYFJAGJÖF OG ÍKOMULEIÐ(IR)
English: Antibody responses to Menveo and the diphtheria, tetanus or HPV vaccine components were not negatively affected by co-administration.
Icelandic: Samtímis gjöf hafði ekki neikvæð áhrif á mótefnasvörun við Menveo og bóluefnisþáttunum gegn barnaveiki, stífkrampa eða HPV.
English: Table 3: Persistence of immune responses 5 years after primary vaccination with Menveo, and immune responses 1 month after a booster dose among subjects aged 2 - 5 years and 6 -10 years at the time of primary vaccination
Icelandic: Varanleiki ónæmissvörunar 5 árum eftir frumbólusetningu með Menveo og ónæmissvörun 1 mánuði eftir örvunarskammt hjá einstaklingum á aldrinum
English: The children also received a booster dose of Menveo, 5 years after a single dose primary vaccination.
Icelandic: örvunarskammt af Menveo 5 árum eftir frumbólusetningu með stökum skammti.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL MENCWY LIQUID CONJUGATE COMPONENT
Icelandic: INNRI UMBÚÐUM LÍTILLA EININGA
English: You should tell your doctor if this happens to you.
Icelandic: Þú skalt segja lækninum þínum frá þessu ef þetta gerist hjá þér.
English: Some patients, who suddenly stop taking YENTREVE after more than 1 week of therapy, have had symptoms such as:
Icelandic: Sumir sjúklingar, sem hætta skyndilega að taka YENTREVE eftir meira en 1 viku meðferð, hafa fengið einkenni eins og:
English: The potential risk for humans is unknown.
Icelandic: Möguleg hætta hjá mönnum er óþekkt.
English: The following are reasons why YENTREVE may not be suitable for you.
Icelandic: Eftirfarandi eru ástæður sem gætu valdið því að YENTREVE henti þér ekki.
English: de la Industria Nº 30, 28108 Alcobendas Madrid
Icelandic: Avenida de la Industria N° 30 28108 Alcobendas Madrid
English: You should take extra care if you drink alcohol while taking YENTREVE.
Icelandic: Þú skalt fara sérstaklega varlega ef þú ákveður að neyta áfengis á meðan þú tekur YENTREVE.
English: The recommended dose of YENTREVE is 40 mg twice a day (in the morning and late afternoon/evening).
Icelandic: Venjulegur skammtur af YENTREVE er 40 mg tvisvar á dag (að morgni og síðdegis/að kvöldi).
English: Your doctor should decide whether you can take YENTREVE with other medicines.
Icelandic: Læknirinn ákveður hvort þú getir tekið YENTREVE með öðrum lyfjum.
English: You must wait at least 14 days after you have stopped taking an MAOI before you can take YENTREVE.
Icelandic: Þú verður að bíða í að minnsta kosti 14 daga frá því að þú hættir að taka MAO-hemil áður en þú mátt taka YENTREVE.
English: Dyskinesia Restless legs syndrome
Icelandic: Hreyfibilun Fótaóeirð (Restless legs syndrome)
English: Your doctor will tell you if you should be taking YENTREVE.
Icelandic: Læknirinn mun segja þér hvort þú ættir að taka YENTREVE áfram.
English: It may harm them,
Icelandic: YENTREVE Hugsanlegar aukaverkanir
English: • feeling the heart pumping in the chest, fast and/or irregular heart beat
Icelandic: Finnast hjartað banka í brjóstinu, hraður og/eða óreglulegur hjartsláttur
English: Suicidal ideation5,7
Icelandic: Sjálfsvígshugleiðingar5,7
English: Date of first authorisation: 11 August 2004 Date of latest renewal: 24 June 2009
Icelandic: 11. ágúst 2004 Nýjasta dagsetning endurnýjunar markaðsleyfis:
English: The use of more than one of these products concomitantly should be avoided.
Icelandic: Forðast skal notkun á fleiri en einum af þessum lyfjum samtímis.
English: • Make sure your midwife and/or doctor knows you are on YENTREVE.
Icelandic: Vertu viss um að ljósmóðirin og/eða læknirinn viti að þú ert að taka YENTREVE.