FrancophonIA/ELRC3.0 huggingface dataset:
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking this medicine.
Icelandic: Leitaðu ráða hjá lækninum, lyfjafræðingi eða hjúkrunarfræðingnum ef eitthvað af þessu á við (eða ef þú ert ekki viss) áður en þú notar lyfið.
English: Titanium dioxide (E171) Black iron oxide (E172) Red iron oxide (E172)
Icelandic: Svart járnoxíð (E172) Rautt járnoxíð (E172)
English: Angioedema Panniculitis
Icelandic: Kroskarmellósanatríum
English: First restart at 560 mg daily restart at 420 mg daily
Icelandic: Hefja aftur með 560 mg á sólarhring
English: HR (95% CI) Overall Response Rate CR
Icelandic: HR (95% CI) Heildarsvörunartíðni a (%)
English: Cases of leukostasis have been reported in patients treated with IMBRUVICA.
Icelandic: Tilkynnt hefur verið um tilvik millivefjalungnasjúkdóms hjá sjúklingum í meðferð með IMBRUVICA.
English: PHARMACEUTICAL FORM AND CONTENTS 10 film-coated tablets
Icelandic: 10 filmuhúðaðar töflur
English: Patients with CLL who received at least one prior therapy Single agent
Icelandic: Sjúklingar með CLL sem fengið hafa áður a.m.k.
English: Population pharmacokinetics data indicated that body weight (range: 41-146 kg; mean [SD]: 83 [19 kg]) had a negligible effect on ibrutinib clearance.
Icelandic: Rannsóknir á lyfjahvörfum sjúklingahópa benda til að líkamsþyngd (á bilinu:41-146 kg; meðaltal (staðalfrávik):
English: IMBRUVICA contains lactose
Icelandic: IMBRUVICA inniheldur
English: All patients in clinical studies received IMBRUVICA until disease progression or no longer tolerated.
Icelandic: IMBRUVICA þar til sjúkdómur versnaði eða lyfið þoldist ekki lengur.
English: Table 8: Subgroup analysis of PFS (Study PCYC-1112-CA)
Icelandic: Greining í undirhópum á lifun án versnunar sjúkdóms (Study PCYC-1112-CA)
English: Figure 8: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1127-CA
Icelandic: Kaplan-Meier graf fyrir lifun án versnunar sjúkdóms (þýði samkvæmt meðferðaráætlun (ITT)) í rannsókn PCYC-1127-CA
English: Subdural haematoma
Icelandic: Innihald hylkis
English: Consider the risks and benefits of anticoagulant or antiplatelet therapy when co-administered with IMBRUVICA.
Icelandic: Hafa þarf í huga áhættu og ávinning af meðferð segavarnarlyfja og blóðflöguhemjandi lyfja við gjöf samhliða IMBRUVICA.
English: Leukostasis
Icelandic: Brjóstagjöf
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 420 mg film-coated tablets ibrutinib
Icelandic: IMBRUVICA 420 mg filmuhúðaðar töflur ibrutinib
English: Figure 5: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1130-CA
Icelandic: Kaplan-Meier grafi fyrir lifun án versnunar sjúkdóms (þýði samkvæmt meðferðaráætlun (ITT)) í rannsókn PCYC-1130-CA
English: • non-melanoma skin cancer, most frequently squamous cell and basal cell skin cancer
Icelandic: húðkrabbamein sem ekki er sortuæxli, algengust eru flöguþekjukrabbamein og grunnfrumukrabbamein
English: Neoplasms benign and malignant (incl cysts and polyps)
Icelandic: Æxli, góðkynja, illkynja og ótilgreind (einnig blöðrur og separ)
English: IMBRUVICA therapy should be withheld for any new onset or worsening grade ≥3 non-haematological toxicity, grade 3 or greater neutropenia with infection or fever, or grade 4 haematological toxicities.
Icelandic: Gera á hlé á meðferð með IMBRUVICA við nýtilkomnar eiturverkanir eða versnun eiturverkana af gráðu
English: IMBRUVICA 140 mg film-coated tablets: Each tablet contains 140 mg of ibrutinib.
Icelandic: Hver filmuhúðuð tafla inniheldur 140 mg ibrutinib.
English: Median PFS
Icelandic: PC SN NN
English: Cases of hepatitis B reactivation have been reported in patients receiving IMBRUVICA.
Icelandic: B hjá sjúklingum á meðferð með IMBRUVICA.
English: You may feel tired or dizzy after taking IMBRUVICA, which may affect your ability to drive or use any tools or machines.
Icelandic: Þú getur fundið fyrir þreytu eða sundli eftir töku
English: WM
Icelandic: TTnT
English: Administer supportive care including hydration and/or cytoreduction as indicated.
Icelandic: Veita skal stuðningsmeðferð þ.m.t. vökvun og/eða frumufækkandi meðferð eftir ástandi.
English: • skin rash
Icelandic: Rai stig
English: Stop taking IMBRUVICA and tell a doctor straight away if you notice any of the following side effects: itchy bumpy rash, difficulty breathing, swelling of your face, lips, tongue or throat - you may be having an allergic reaction to the medicine.
Icelandic: Þrútin kláðaútbrot, öndunarerfiðleikar, þroti í andliti, vörum, tungu eða koki - þú getur hafa fengið ofnæmisviðbrögð við lyfinu.
English: EU/1/14/945/007 - 28 tablets (2 wallet packs of 14) EU/1/14/945/008 - 30 tablets (3 wallet packs of 10)
Icelandic: IMBRUVICA 140 mg filmuhúðaðar töflur EU/1/14/945/007 - 28 töflur (2 vasar með 14) EU/1/14/945/008 - 30 töflur (3 vasar með 10)
English: Stomatitis
Icelandic: Töflukjarni
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 560 mg film-coated tablets ibrutinib
Icelandic: IMBRUVICA 560 mg filmuhúðaðar töflur ibrutinib
English: Paediatric population
Icelandic: Fjöldi meðferðartegunda
English: • severe infections throughout the body (sepsis)
Icelandic: svæsin sýking dreifð um líkamann (sýklasótt)
English: Progression-free survival (PFS) was assessed by IRC according to IWCLL criteria indicated a 77% statistically significant reduction in the risk of death or progression in the IMBRUVICA arm. With a median follow-up time on study of 31 months, the median PFS was not reached in the IMBRUVICA+obinutuzumab arm and was 19 months in the chlorambucil+obinutuzumab arm. Efficacy results for Study PCYC-1130-CA are shown in Table 5 and the Kaplan-Meier curve for PFS is shown in Figure 5.
Icelandic: Við 31 mánaða (miðgildi) eftirfylgni rannsóknarinnar var miðgildi lifunar án versnunar sjúkdóms ekki náð í IMBRUVICA+obinutuzumab hópnum en var 19 mánuðir í chlorambucil+obinutuzumab hópnum.
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 280 mg film-coated tablets ibrutinib
Icelandic: IMBRUVICA 280 mg filmuhúðaðar töflur ibrutinib
English: Progression free survival (PFS) as assessed by IRC according to International Workshop on CLL (IWCLL) criteria indicated an 84% statistically significant reduction in the risk of death or progression in the IMBRUVICA arm. Efficacy results for Study PCYC-1115-CA are shown in Table 4 and the Kaplan-Meier curves for PFS and OS are shown in Figures 2 and 3, respectively.
Icelandic: Lifun án versnunar sjúkdóms samkvæmt mati óháðrar eftirlitsnefndar (IRC) samkvæmt viðmiðum IWCLL (International Workshop on CLL) bentu til 84% tölfræðilega marktækrar minnkunar á hættunni á dauðsfalli eða versnun sjúkdóms í IMBRUVICA arminum.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 420 mg of ibrutinib
Icelandic: Hver filmuhúðuð tafla inniheldur 420 mg af ibrutinibi
English: Table 11: Efficacy results in Study PCYC-1127-CA Endpoint
Icelandic: PCYC-1127-CA
English: SN:
Icelandic: Fylgiseðill:
English: Includes multiple adverse reaction terms.
Icelandic: * Þar með talin önnur hugtök aukaverkana.
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 140 mg hard capsules
Icelandic: IMBRUVICA 140 mg hörð hylki.
English: Musculoskeletal pain
Icelandic: Lungabólga af gráðu
English: Colloidal anhydrous silica Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Povidone
Icelandic: Laktósamónóhýdrat Magnesíumsterat Örkristallaður sellulósi Povidon
English: EU/1/14/945/006 (30 tablets)
Icelandic: EU/1/14/945/012 (28 töflur) EU/1/14/945/006 (30 töflur)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 560 mg of ibrutinib
Icelandic: Hver filmuhúðuð tafla inniheldur 560 mg af ibrutinibi
English: Petechiae
Icelandic: Prentblek
English: EU/1/14/945/011 - 28 tablets (2 wallet packs of 14) EU/1/14/945/005 - 30 tablets (3 wallet packs of 10)
Icelandic: EU/1/14/945/011 (28 töflur) EU/1/14/945/005 (30 töflur)
English: EU/1/14/945/008 (30 tablets)
Icelandic: EU/1/14/945/007 (28 töflur) EU/1/14/945/008 (30 töflur)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 140 mg of ibrutinib
Icelandic: Hver filmuhúðuð tafla inniheldur 140 mg af ibrutinibi
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 280 mg of ibrutinib
Icelandic: Hver filmuhúðuð tafla inniheldur 280 mg af ibrutinibi
English: EU/1/14/945/009 - 28 tablets (2 wallet packs of 14) EU/1/14/945/010 - 30 tablets (3 wallet packs of 10)
Icelandic: EU/1/14/945/009 (28 töflur) EU/1/14/945/010 (30 töflur)
English: Table 6: Subgroup Analysis of PFS (Study PCYC-1130-CA) N Hazard Ratio
Icelandic: Lifun án versnunar sjúkdóms samkvæmt greiningu á undirflokkum (rannsókn PCYC-1130-CA)
English: There was a statistically significant sustained platelet or haemoglobin improvement in the ITT population in favor of ibrutinib versus chlorambucil.
Icelandic: Tölfræðilega marktæk viðvarandi bæting sást hvað varðar blóðflögur og hemóglóbín hjá þýði samkvæmt meðferðaráætlun (ITT) í hópnum sem fékk ibrutinib umfram hópinn sem fékk chlorambucil.
English: EU/1/14/945/012 - 28 tablets (2 wallet packs of 14) EU/1/14/945/006 - 30 tablets (3 wallet packs of 10)
Icelandic: IMBRUVICA 560 mg filmuhúðaðar töflur EU/1/14/945/012 - 28 töflur (2 vasar með 14) EU/1/14/945/006 - 30 töflur (3 vasar með 10)
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 140 mg capsules ibrutinib
Icelandic: IMBRUVICA 140 mg hylki ibrutinib
English: Non-melanoma skin cancer Basal cell carcinoma Squamous cell carcinoma
Icelandic: Húðkrabbamein sem ekki er sortuæxli* Grunnfrumukrabbamein Flöguþekjukrabbamein
English: Skin infection
Icelandic: útbrot á húð
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Icelandic: Fargið ónotuðum lyfjum í samræmi við gildandi reglur.
English: Progression free survival (PFS) as assessed by IRC indicated an 80% statistically significant reduction in the risk of death or progression in the IMBRUVICA arm. Efficacy results for Study PCYC-1127CA are shown in Table 11 and the Kaplan-Meier curve for PFS is shown in Figure 8.
Icelandic: Kaplan-Meier graf fyrir lifun án versnunar sjúkdóms er sýnt á mynd 7. Heildarsvörunartíðni samkvæmt mati rannsakanda var 87,7% í IMBRUVICA hópnum og 22,4% í ofatumumab hópnum.
English: Recommended dose modifications are described below:
Icelandic: Í fylgiseðlinum eru eftirfarandi kaflar:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 October 2014
Icelandic: DAGSETNING FYRSTU ÚTGÁFU MARKAÐSLEYFIS / ENDURNÝJUNAR MARKAÐSLEYFIS
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL 140 MG CAPSULE
Icelandic: MERKIMIÐI Á GLASI 140 MG HYLKI
English: Cardiac disorders
Icelandic: Depilblæðingar
English: • constipation
Icelandic: • þokusýn
English: In vitro platelet aggregation
Icelandic: Blóðflagnasamloðun in vitro
English: Analysis of OS demonstrated a 57% statistically significant reduction in the risk of death for patients in the IMBRUVICA arm. Efficacy results for Study PCYC-1112-CA are shown in Table 7.
Icelandic: (OS) sýndi fram á 57% tölfræðilega marktækt minni hættu á dauðsfalli hjá sjúklingum í IMBRUVICA hópnum.
English: Progression free survival (PFS) as assessed by an IRC according to IWCLL criteria indicated a 78% statistically significant reduction in the risk of death or progression for patients in the IMBRUVICA
Icelandic: Lifun án versnunar sjúkdóms samkvæmt mati óháðrar eftirlitsnefndar (IRC) og viðmiðum IWCLL (International Workshop on CLL) bentu til 77% tölfræðilega marktækrar minnkunar á hættu á dauðsfalli eða versnun í IMBRUVICA hópnum.
English: Very common Haemorrhage Bruising Hypertension
Icelandic: Æxlislýsuheilkenni Þvagsýruaukning í blóði
English: • medicines to prevent seizures or to treat epilepsy, or medicines to treat a painful condition of the face called trigeminal neuralgia - carbamazepine or phenytoin.
Icelandic: lyf til að hindra krampa eða við flogaveiki eða lyf við sársauka í andliti, sem nefnist vangahvot
English: Reporting of side effects
Icelandic: Niðurstöður verkunar fyrir
English: HR=hazard ratio; CI=confidence interval; ORR=overall response rate; OS=overall survival; PFS=progression-free survival; PR=partial response
Icelandic: CI = öryggisbil; HR = hættuhlutfall; ORR = heildarsvörunartíðni; OS = heildarlifun
English: Renal impairment
Icelandic: brotnar neglur
English: MA (EU) number (Invented) name Strength Pharmaceutical form Route of administration Immediate Packaging Pack size EU/1/12/763/001 Ecansya
Icelandic: ESB markaðsleyfisnúmer (Sér)heiti Styrkleiki Lyfjaform Íkomuleið Innri umbúðir
English: 1 bottle + 1 oral syringe 10 ml
Icelandic: 1 flaska +
English: Name
Icelandic: Innihald
English: Headache was also seen.
Icelandic: Einnig varð vart við höfuðverk.
English: Some of these reactions have been severe.
Icelandic: Sum þessara viðbragða hafa reynst alvarleg.
English: The median duration of follow-up was 2.9 years.
Icelandic: Meðaltími eftirfylgni var 2,9 ár.
English: Few individuals (0.2%) discontinued due to adverse reactions.
Icelandic: Fáir einstaklingar (0,2%) hættu þátttöku vegna aukaverkana.
English: Fever and nausea have also been reported.
Icelandic: Einnig hefur verið tilkynnt um hita og ógleði.
English: Afterwards, the GMTs declined through Month 24 - 48 and then generally stabilized.
Icelandic: Eftir það lækkuðu GMT á mánuðum 24 til 48 og urðu síðan yfirleitt stöðugir.
English: HIV infection was an exclusion criterion (see also section 4.4).
Icelandic: HIV sýking var útilokunarskilyrði (sjá einnig kafla 4.4).
English: If you miss a scheduled injection, your doctor will decide when to give the missed dose.
Icelandic: Ef þú missir af áætlaðri sprautu mun læknirinn ákveða hvenær á að gefa skammtinn sem gleymdist.
English: The following information is intended for medical or healthcare professionals only:
Icelandic: Eftirfarandi upplýsingar eru eingöngu ætlaðar læknum og heilbrigðisstarfsfólki:
English: If you forget or are not able to go back to your doctor at the scheduled time, ask your doctor for advice.
Icelandic: Ef þú gleymir að mæta eða kemst ekki til læknisins á tilsettum tíma skaltu leita ráða hjá lækninum.
English: Read all of this leaflet carefully before you or your child are vaccinated.
Icelandic: Lesið allan fylgiseðilinn vandlega áður en þú eða barnið þitt er bólusett.
English: Efficacy was measured starting after the Month 7 visit.
Icelandic: Byrjað var að mæla virkni eftir heimsókn í 7. mánuði.
English: You should continue to follow your doctor's advice on cervical smear/Pap tests and preventative and protective measures.
Icelandic: Þú ættir að fylgja ráðum læknisins hvað varðar leghálsstrok/Pap-strok og forvarnar- og varnaraðgerðir.
English: It is important that procedures are in place to avoid injury from faints.
Icelandic: Mikilvægt er að gera ráðstafanir til að koma í veg fyrir meiðsli vegna aðsvifa.
English: • has a bleeding disorder (a disease that makes you bleed more than normal), for example haemophilia
Icelandic: • hefur blæðingarsjúkdóm (sjúkdómur sem veldur því að þér blæðir meira en eðlilegt þykir), t.d.
English: Please tell your doctor or pharmacist if you or your child are taking or have taken recently any other medicines, including medicines obtained without a prescription.
Icelandic: Látið lækninn eða lyfjafræðing vita ef þú eða barnið þitt tekur eða hefur nýverið tekið önnur lyf, einnig þau sem fengin eru án lyfseðils.
English: * Post-Marketing adverse events (frequency cannot be estimated from the available data).
Icelandic: * Aukaverkanir eftir markaðssetningu (ekki hægt að áætla tíðni út frá fyrirliggjandi gögnum).
English: EXP MM/YYYY
Icelandic: EXP MM/ÁÁÁÁ
English: What other important information should you or your child know about Silgard
Icelandic: Hvað fleira er nauðsynlegt fyrir þig eða barnið þitt að vita um Silgard
English: GMT- Geometric mean titre in mMU/ml (mMU = milli-Merck units)
Icelandic: GMT- Margfeldismeðaltalstítri sem mMU/ml (mMU= milli-Merck einingar)
English: Do not receive Silgard if:
Icelandic: Ekki má nota Silgard ef:
English: The safety and efficacy of Silgard in children below 9 years of age have not been established.
Icelandic: Ekki hefur verið sýnt fram á öryggi og verkun Silgard hjá börnum yngri en 9 ára.
English: What Silgard is and what it is used for
Icelandic: Upplýsingar um Silgard og við hverju það er notað
English: If you are from 9 to and including 13 years of age
Icelandic: Ef þú ert á aldrinum 9 ára til og með 13 ára
English: 16- to 26-Year-Old Women (Protocols 013 and 015) GMT (95% CI)
Icelandic: 16- til 26- ára konur (Rannsóknaráætlun 013 og 015) GMT (95% CI)
English: Rare: urticaria.
Icelandic: Mjög sjaldgæfar:
English: Individuals who develop symptoms indicative of hypersensitivity after receiving a dose of Silgard should not receive further doses of Silgard.
Icelandic: Einstaklingar sem fá einkenni sem gefa til kynna ofnæmi eftir að hafa fengið skammt af Silgard ættu ekki að fá fleiri skammta af Silgard.
English: Silgard is intended for adolescents and adults from 9 years of age onwards.
Icelandic: Silgard er ætlað unglingum og fullorðnum 9 ára og eldri.
English: The CD4% or plasma HIV RNA was not affected by vaccination.
Icelandic: Bólusetningin hafði ekki áhrif á CD4% eða HIV RNA í plasma.
English: [Very Common (≥1/10); Common (≥1/100 to 1/10); Uncommon (≥1/1,000 to 1/100); Rare (≥1/10,000 to 1/1,000); Very Rare (1/10,000)]
Icelandic: [Mjög algengar (≥ 1/10), algengar (≥ 1/100 til <1/10), sjaldgæfar (≥ 1/1.000 til <1/100), mjög sjaldgæfar (≥ 1/10.000 til <1/1.000), koma örsjaldan fyrir (<1/10.000)]
English: % Efficacy
Icelandic: % Verkun
English: Silgard is given as an injection by your doctor.
Icelandic: Silgard er gefið sem stungulyf af lækninum.
English: There was no evidence of protection from disease caused by vaccine HPV types for which women were PCR positive at day 1.
Icelandic: Ekki var hægt að sýna fram á vörn gegn sjúkdómum af völdum HPV gerða bóluefnisins sem konur voru PCR jákvæðar fyrir á fyrsta degi.
English: The following side effects can be seen after the use of Silgard:
Icelandic: Eftirfarandi aukaverkanir geta komið fram eftir notkun Silgard:
English: 40 micrograms
Icelandic: 40 míkrógrömm
English: • has a weakened immune system, for example due to a genetic defect, HIV infection or medicines that affect the immune system.
Icelandic: • hefur veikt ónæmiskerfi, til dæmis af völdum erfðagalla, HIV sýkingar eða lyfja sem hafa áhrif
English: The primary time point analysis after 3 years did not reach statistical significance for all pre-specified endpoints.
Icelandic: Á aðal tímapunkti greiningar eftir 3 ár fengust ekki marktækar niðurstöður fyrir öllum fyrirfram skilgreindum endapunktum.
English: Silgard is intended to prevent these diseases.
Icelandic: Silgard er ætlað að fyrirbyggja þessa sjúkdóma.
English: The differences observed were < 10% and in the majority of subjects, the adverse events were reported as mild to moderate in intensity.
Icelandic: Mismunurinn var < 10% og hjá flestum einstaklingum voru aukaverkanirnar sagðar vera vægar til miðlungsmiklar.
English: Silgard may be given to women who are breast-feeding or intend to breast-feed.
Icelandic: Silgard má gefa konum sem hafa barn á brjósti eða hafa áform um brjóstagjöf.
English: Use of hormonal contraceptives did not appear to affect the immune response to Silgard.
Icelandic: Notkun hormónagetnaðarvarna virtist ekki hafa áhrif á ónæmissvörun við Silgard.
English: Silgard Placebo
Icelandic: Silgard Lyfleysa
English: Safety and immunogenicity of the vaccine have been assessed in individuals aged from 7 to 12 years who are known to be infected with human immunodeficiency virus (HIV) (see section 5.1).
Icelandic: Öryggi og ónæmingargeta bóluefnisins hefur verið metin hjá einstaklingum á aldrinum 7 til 12 ára sem vitað er að eru smitaðir af eyðniveiru (HIV) (sjá kafla 5.1).
English: The primary analysis was done in type-specific populations that required women to be negative for the type being analyzed, but who could be positive for other HPV types (96% of the overall population).
Icelandic: Aðal greiningin var gerð á einstaklingum með tilteknar gerðir og voru fengnar til þess konur sem voru neikvæðar fyrir gerðinni sem var greind, en gátu verið jákvæðar fyrir öðrum HPV gerðum (96% af heildarrannsóknarþýði).
English: In all clinical trials, individuals who had received immunoglobulin or blood-derived products during the 6 months prior to the first vaccine dose were excluded.
Icelandic: Í öllum klínískum rannsóknum voru einstaklingar sem fengið höfðu immúnóglóbúlín eða blóðafurðir á 6 mánaða tímabili fyrir fyrsta bólusetningarskammtinn undanskildir.
English: Silgard should be administered as soon as possible after being removed from the refrigerator.
Icelandic: Silgard skal gefið eins fljótt og unnt er eftir að það er tekið úr kæli.
English: Clinical Studies
Icelandic: Klínískar rannsóknir
English: *Number of individuals with at least one follow-up visit after 30 days after Day 1 **Percent efficacy is calculated from the combined protocols.
Icelandic: *Fjöldi einstaklinga með minnst eina eftirfylgni eftir 30 daga eftir 1. dag **Prósentuvirkni er reiknuð út frá sameinuðum rannsóknaráætlunum.
English: Safety was evaluated in either the entire study population (6 studies) or in a predefined subset (one study) of the study population using vaccination report card (VRC)-aided surveillance for 14 days after each injection of Silgard or placebo.
Icelandic: Öryggi var metið, annað hvort hjá rannsóknarþýðinu í heild (6 rannsóknir) eða hjá fyrirfram ákveðnu undirúrtaki (ein rannsókn) rannsóknarþýðisins með eftirliti þar sem notuð voru tilkynningarspjöld í tengslum við bólusetningu (VRC) í 14 daga eftir hvern skammt af Silgard eða lyfleysu.
English: • you or your child suffer from an illness with high fever.
Icelandic: þú eða barnið þitt er með sjúkdóm sem fylgir hiti.
English: The median duration of follow-up for this study was 4.0 years.
Icelandic: Miðgildi tímalengdar eftirfylgni var 4,0 ár í þessari rannsókn.
English: The requirement for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines
Icelandic: Skilyrði um hvernig leggja skal fram samantektir um öryggi lyfsins koma fram í lista yfir viðmiðunardagsetningar Evrópusambandsins (EURD lista) sem gerð er krafa um í grein 107c(7) í tilskipun 2001/83/EB og öllum síðari uppfærslum sem birtar eru í evrópsku lyfjavefgáttinni.
English: No effects on male fertility were observed in rats (see section 5.3).
Icelandic: Ekki komu fram áhrif á frjósemi hjá karlkynsrottum (sjá kafla 5.3).
English: • you or your child developed an allergic reaction after receiving a dose of Silgard.
Icelandic: þú eða barnið þitt hafið fengið ofnæmisviðbrögð eftir að hafa fengið skammt af Silgard.
English: Talk to your doctor, pharmacist or nurse before vaccination if you or your child
Icelandic: Leitið ráða hjá lækninum, lyfjafræðingi eða hjúkrunarfræðingnum áður en Silgard er notað ef þú eða barnið þitt
English: It is important that you follow the instructions of your doctor or nurse regarding return visits for the follow-up doses.
Icelandic: Mikilvægt er að fylgja leiðbeiningum læknisins eða hjúkrunarfræðings hvað varðar endurkomur til að fá þá skammta sem eftir eru.
English: The results are summarised in Table 3.
Icelandic: Niðurstöður eru dregnar saman í töflu 3.
English: Although fainting episodes are uncommon, patients should be observed for 15 minutes after they receive HPV vaccine.
Icelandic: Þó svo sjaldgæft sé að sjúklingur falli í yfirlið þarf að fylgjast með sjúklingum í 15 mínútur eftir að þeir eru bólusettir með
English: It is recommended that individuals who receive a first dose of Silgard complete the vaccination course
Icelandic: Mælt er með því að einstaklingar sem fá fyrsta skammt af Silgard ljúki bólusetningaráætluninni með