FrancophonIA/ELRC3.0 huggingface dataset:
English: The educational programme is aimed at increasing awareness and providing information concerning the signs and symptoms of certain important identified risks of padeliporfin, including photosensitivity, and also information on the existing therapeutic approaches (including VTP with
Icelandic: Fræðsluáætlunin miðar að því að auka vitund og veita upplýsingar um einkenni tiltekinna mikilvægra greindra áhættuþátta sem tengjast padeliporfíni, þ.m.t. ljósnæmi, og einnig að veita upplýsingar um núgildandi lækningaaðferðir (þ.m.t. VTP með TOOKAD) til meðferðar við þessari tegund krabbameins í blöðruhálskirtli, hugsanlegan ávinning, áhættu og óvissu hvað varðar VTP með TOOKAD.
English: Standard handling of syringes should follow.
Icelandic: Meðhöndla skal sprautur á hefðbundinn hátt.
English: After reconstitution with a 5 % glucose solution in its vial, the chemical and physical stability of TOOKAD has been demonstrated for 8 hours at 15°C-25°C and at 5°C ± 3°C.
Icelandic: Eftir blöndun með 5% glúkósalausn í hettuglasinu hefur verið sýnt fram á efna- og eðlisfræðilegan stöðugleika TOOKAD í 8 klukkustundir við 15°C-25°C og við 5°C ± 3°C. Frá örverufræðilegu sjónarmiði skal nota lyfið strax.
English: Urethral stenosis
Icelandic: A. ÁLETRANIR
English: Rapid consumption of the •NO radicals, by oxygen radicals, leads to the formation of reactive nitrogen species (RNS) (e.g. peroxynitrite), in parallel to arterial constriction.
Icelandic: Hröð notkun súrefnisstakeindanna á •NO stakeindunum leiðir til myndunar á hvarfgjörnum köfnunarefnistegundum (RNS) (t.d. peroxýnítríts), samhliða slagæðaþrengingu.
English: Skin depigmentation Skin reaction
Icelandic: Viðbrögð í húð
English: TOOKAD is indicated as monotherapy for adult patients with previously untreated, unilateral, low-risk, adenocarcinoma of the prostate with a life expectancy ≥ 10 years and: - Clinical stage T1c or T2a, - Gleason Score ≤ 6, based on high-resolution biopsy strategies, - PSA ≤ 10 ng/mL, - 3 positive cancer cores with a maximum cancer core length of 5 mm in any one core or 1-2 positive cancer cores with ≥ 50 % cancer involvement in any one core or a PSA density ≥ 0.15 ng/mL/cm
Icelandic: - Klínískt stig T1c eða T2a, - Gleason-stig ≤ 6, byggt á aðferðum með mikilli upplausn við vefjasýnatöku, - PSA ≤ 10 ng/ml, - 3 jákvæðir krabbameinskjarnar með hámarkslengd 5 mm í einhverjum kjarna eða 1-2 jákvæðir krabbameinskjarnar með ≥ 50% krabbameins í einhverjum kjarna eða PSA-þéttleika sem er ≥ 0,15 ng/mL/cm3.
English: The most common infections are orchitis, epididymitis and urinary tract infections including cystitis.
Icelandic: Algengustu sýkingarnar eru eistnabólga, lyppubólga og þvagfærasýkingar, þ.m.t. blöðrubólga.
English: Anticoagulants (medicines that prevent the blood from clotting) These medicines (e.g. acenocoumarol, warfarin) should be stopped at least 10 days before the VTP procedure with TOOKAD.
Icelandic: Segavarnarlyf (lyf sem koma í veg fyrir blóðtappa) Meðferð með þessum lyfjum (t.d. asenókúmaróli, warfaríni) skal stöðvuð a.m.k.
English: Reconstitution of the TOOKAD powder for solution for injection The solution must be prepared in a dimmed-light environment due to the photosensitizing properties of the medicine.
Icelandic: Undirbúa þarf lausnina í umhverfi með daufri lýsingu vegna ljósnæmiseiginleika lyfsins.
English: Surgical procedure repeated Contusion
Icelandic: Skurðaðgerð endurtekin
English: See also under “Other medicines and TOOKAD” for the effects of anticoagulants and antiplatelet medicines.
Icelandic: Sjá einnig upplýsingar um áhrif segavarnarlyfja og blóðflöguhemjandi lyfja undir „Önnur lyf og TOOKAD“.
English: Photosensitivity There is a risk of skin and eye photosensitivity with exposure to light post TOOKAD-VTP.
Icelandic: Hætta er á ljósnæmi í húð og augum við útsetningu fyrir ljósi eftir TOOKAD-VTP aðgerð.
English: One patient had Grade 3 perineal pain that started 35 weeks after the VTP procedure, and lasted for about 35 weeks before resolving without sequelae.
Icelandic: Einn sjúklingur var með 3. stigs verk í spöng sem hófst 35 vikum eftir VTP aðgerðina og stóð yfir í u.þ.b.
English: Connect an opaque tube to the filter.
Icelandic: Tengið ógegnsæja slöngu við síuna.
English: VTP procedure.
Icelandic: VTP.
English: Nervous system disorders
Icelandic: Bilun í laserbúnaði
English: Illumination for photoactivation of TOOKAD
Icelandic: Lýsing fyrir ljósörvun TOOKAD.
English: The use of medicines such as repaglinide, atorvastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin, bosentan, glyburide should be avoided on the day of TOOKAD administration and for at least 24 hours after administration.
Icelandic: Forðast skal notkun lyfja eins og repaglíníðs, atorvastatíns, pitavastatíns, pravastatíns, rosuvastatíns, simvastatíns, bósentans og glýbúríðs daginn sem TOOKAD er gefið og í a.m.k.
English: Patients on a controlled potassium diet
Icelandic: Sjúklingar á kalíumskertu mataræði
English: Adjusted Hazard Ratio (95% CI) = 0.34 (0.24 ; 0.46) ; p value ≤ 0.001
Icelandic: aÁhættuhlutfall (95% CI) = 3,62 (2,50; 5,26); p gildi < 0,001 bÁhættuhlutfall (95% CI) = 3,24 (2,41; 4,36); p gildi < 0,001
English: Unspecific adverse events probably linked to the general anaesthesia were also observed: transient global amnesia, bradycardia, sinus arrhythmia, atrial fibrillation, hypotension, bronchospasm, pharyngeal inflammation, respiratory tract congestion, nausea, vomiting, constipation, pyrexia, procedural hypotension.
Icelandic: Ótilgreindar aukaverkanir sem líklega tengjast svæfingunni komu einnig fram: tímabundið og víðtækt minnisleysi, hægsláttur, hjartsláttartruflanir, gáttatif, lágþrýstingur, berkjukrampi, bólga í barkakýli, þrengsli í öndunarfærum, ógleði, uppköst, hægðatregða, sótthiti, meðferðartengdur lágþrýstingur.
English: Each vial contains 366 mg of padeliporfin (as di-potassium salt).
Icelandic: Hvert hettuglas inniheldur 366 mg af padeliporfíni (sem díkalíumsalt).
English: Activation within the illuminated tumour vasculature, generates oxygen radicals (•OH, O•
Icelandic: Virkjun innan upplýstrar æðaskipunar æxlisins myndar súrefnisstakeindir (•
English: Name and address of the manufacturer responsible for batch release
Icelandic: Heiti og heimilisfang framleiðenda líffræðilegra virkra efna
English: Current exacerbation of rectal inflammatory bowel disease (see section 4.4).
Icelandic: Yfirstandandi versnun á bólgusjúkdómi í endaþarmi og þörmum (sjá kafla 4.4).
English: Risk of damage near the prostate gland
Icelandic: Hætta á skemmdum nálægt blöðruhálskirtlinum
English: Patients with abnormal clotting may develop excessive bleeding due to the insertion of the needles required to position the light fibres.
Icelandic: Notkun hjá sjúklingum með óeðlilega blóðstorknun Sjúklingum með óeðlilega blóðstorknun getur blætt óhóflega við innsetningu nálanna sem þarf til að koma ljóstrefjunum fyrir.
English: Medicines with a potentially photosensitising effect: - Certain antibiotics used to treat infection (tetracyclines, sulphonamides, quinolones).
Icelandic: - Ákveðin sýklalyf sem notuð eru til að meðhöndla sýkingu (tetrasýklín, súlfónamíð, kínólón).
English: Posology The recommended posology of TOOKAD is one single dose of 3.66 mg/kg of padeliporfin.
Icelandic: Skammtar Ráðlagður skammtur af TOOKAD er einn stakur 3,66 mg/kg skammtur af padeliporfíni.
English: g g h
Icelandic: B. FYLGISEÐILL
English: Each vial contains 183 mg of padeliporfin (as di-potassium salt).
Icelandic: Hvert hettuglas inniheldur 183 mg af padeliporfíni (sem díkalíumsalt).
English: - You are not able to have general anaesthesia or invasive procedures.
Icelandic: - Ef þú getur ekki gengist undir svæfingu eða ífarandi aðgerðir.
English: No biopsy result, n (%) Subjects who had radical therapy leading to missing biopsy, n (%)
Icelandic: Þátttakendur sem fengu róttæka meðferð sem leiddi til tapaðs vefjasýnis, n
English: In some cases pain relief was required for perineal pain or anorectal discomfort.
Icelandic: Í sumum tilvikum var verkjastilling nauðsynleg við verkjum í spöng eða óþægindum í endaþarmsopi og endaþarmi.
English: n Mean score (SD) Baseline 179 7.6 (6.09) 185 6.6 (5.30) 71 6.7 (5.69) 73 6.0 (4.34) Day 7 180 14.8 (8.64)
Icelandic: Mánuður 3 179 9,6 (6,86) 190 7,2 (5,75)
English: Each carton of TOOKAD 183 mg powder for solution for injection contains an amber glass vial with a blue cap.
Icelandic: Hver askja með TOOKAD 183 mg stungulyfsstofni, lausn inniheldur gulbrúnt hettuglas úr gleri með blárri hettu.
English: • Explain what the VTP procedure involves, including the need to follow the rules to protect the Patient against light after the procedure for 48 hours, due to the photosensitising effect of TOOKAD and provide a copy of the TOOKAD Package Leaflet to the Patient ahead of the VTP procedure
Icelandic: Útskýring á því hvað felst í VTP aðgerðinni, þar á meðal nauðsyn þess að fylgja reglunum til að vernda sjúklinginn gegn ljósi í 48 klst.
English: Libido decreased Affective disorder Encopresis
Icelandic: Áhrif skýribreyta á lyfjahvarfaeiginleika
English: QUALITATIVE AND QUANTITATIVE COMPOSITION TOOKAD 183 mg powder for solution for injection Each vial contains 183 mg of padeliporfin (as di-potassium salt).
Icelandic: TOOKAD 183 mg stungulyfsstofn, lausn Hvert hettuglas inniheldur 183 mg af padeliporfíni (sem díkalíumsalt).
English: In small surgical series, there have been reports of T3 tumours, positive margins and impotence.
Icelandic: T3 æxlum, jákvæðum jöðrum og getuleysi í röð nokkurra lítilla skurðaðgerða.
English: Adjusted Hazard Ratio (95% CI) = 0.31 (0.20 ; 0.50) ; p value ≤ 0.001
Icelandic: eÁhættuhlutfall (95% CI) = 4,39 (2,18; 8,83); p gildi < 0,001 fÁhættuhlutfall (95% CI) = 4,61 (2,60; 8,16); p gildi < 0,001
English: causing local hypoxia that induces the release of nitric oxide (•NO) radicals.
Icelandic: sem valda staðbundnum súrefnisskorti sem veldur losun stakeinda köfnunarefnisoxíðs (•NO).
English: Number of subjects who initiated a radical treatment after progression, n (%)
Icelandic: Fjöldi þátttakenda sem hóf róttæka meðferð, n (%) Fjöldi þátttakenda sem hóf róttæka meðferð eftir versnun, n (%)
English: 6.3 Shelf life
Icelandic: 6.3 Lyfjahvörf
English: These medicines (e.g. acetylsalicylic acid) should be stopped at least 10 days before the VTP procedure with TOOKAD and re-started at least 3 days after the procedure.
Icelandic: 10 dögum fyrir VTP aðgerðina með TOOKAD og hafin að nýju a.m.k.
English: Hepatic impairment
Icelandic: Óeðlileg blóðstorknun
English: A: Rate of absence of definite cancer based on histology at 24 months Negative biopsy, n (%)
Icelandic: Munurinn á hlutfalli meðferðarbrests í tengslum við greinda versnun sjúkdóms Fjöldi þátttakenda sem með versnun í mánuði 24, n (%)
English: Photosensitisers
Icelandic: KLÍNÍSKAR UPPLÝSINGAR
English: Active inflammatory bowel disease
Icelandic: Virkur bólgusjúkdómur í þörmum
English: Genital haemorrhage Penile swelling Prostatic haemorrhage Testicular swelling
Icelandic: Minnkuð kynhvöt Geðröskun Hægðaleki
English: In vitro genotoxicity testing identified padeliporfin as having weak potential to induce clastogenicity when illuminated by ultraviolet (UV); this correlates with the mechanism of action (formation of reactive oxygen species).
Icelandic: Í in vitro rannsóknum á eiturverkunum á erfðaefni kom í ljós að padeliporfín, eftir lýsingu með útfjólubláu (UV) ljósi hefur væg litningaskemmandi áhrif.
English: For the 48 hours after the procedure you should avoid exposure to direct sunlight (including through windows) and all bright light sources, both indoors and outdoors.
Icelandic: Þú þarft að forðast útsetningu fyrir beinu sólarljósi (þ.m.t. í gegnum glugga) og öllum björtum ljósgjöfum, bæði innandyra og utandyra, í 48 klukkustundir eftir meðferðina.
English: In the Phase III European study, 25 (12.7 %) patients experienced urinary incontinence (including incontinence, stress urinary incontinence and urge incontinence).
Icelandic: 25 (12,7%) sjúklingar þvagleka (þ.m.t. þvagleka,
English: As shown in Table 6, in the VTP arm of PCM301 study, erectile function domain scores of the 15-question International Index of Erectile Function (IIEF-15) questionnaire showed a marked decrease, 7 days after the VTP procedure followed by a subsequent improvement in the following months up to Month 24, in the ITT population and in patients meeting the indication criteria.
Icelandic: Eins og fram kemur í töflu 6 sýndu niðurstöður úr 15 spurninga alþjóðlega spurningalistanum varðandi ristruflanir (International Index of Erectile Function (IIEF-15)) greinilega lækkun
English: Progression to Gleason ≥ 4 49 (23.8) Number of subjects progressed in the treated lobe* at Month 24, n (%)
Icelandic: Fjöldi þátttakenda sem sýndu versnun í meðhöndlaða blaðinu* í mánuði 24, n (%)
English: Ureteric haemorrhage Urethral haemorrhage Urinary tract disorders
Icelandic: Stoðkerfisverkir Verkur í útlimum
English: The patient may only use incandescent light bulbs with a maximum power of
Icelandic: Sjúklingurinn má aðeins nota glóperur með hámarksstyrkinn 60 W eða jafngildi þess (þ.e.
English: Perineal injury, perineal pain and prostatitis
Icelandic: Áverkar og verkir í spöng og blöðruhálskirtilsbólga
English: TOOKADVTP arm N = 80
Icelandic: TOOKAD-VTP armi N = 80
English: TOOKADVTP arm N = 206
Icelandic: TOOKAD-VTP armi N = 206
English: Severe long-term urinary incontinence was observed in a patient who underwent a previous transurethral prostatectomy (TURP).
Icelandic: Verulegur langvinnur þvagleki kom fram hjá sjúklingum sem höfðu áður gengist undir brottnámsaðgerð á blöðruhálskirtli um þvagrás (TURP).
English: Micturition disorders (micturition urgency, pollakiuria, nocturia, urine flow decreased, urinary straining).
Icelandic: Þvaglátskvillar (bráð þvaglátsþörf, óeðlilega tíð þvaglát, næturmiga, minnkað þvagflæði, erfiðleikar við þvaglát).
English: Extraprostatic necrosis There may be extraprostatic necrosis in the peri-prostatic fat not associated with clinical symptoms.
Icelandic: Drep utan blöðruhálskirtils Drep getur komið fram í fitunni í kringum blöðruhálskirtilinn sem ekki tengist klínískum einkennum.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator.
Icelandic: Listi yfir aukaverkanir, settur upp í töflu.
English: If you have any questions on the use of this medicine, ask your doctor, your pharmacist or your nurse.
Icelandic: Leitið til læknisins, lyfjafræðings eða hjúkrunarfræðingsins ef þörf er á frekari upplýsingum um notkun lyfsins.
English: Mean (SD)
Icelandic: Aldur (ár)
English: Range: min, max Estimated prostate volume (cc) Mean (SD)
Icelandic: Áætlað rúmmál blöðruhálskirtils (cm3 (cc))
English: Trans-Urethral Resection of the Prostate (TURP).
Icelandic: Samantektir um öryggi lyfsins (PSUR)
English: The reconstituted solution for infusion is dark.
Icelandic: Blandaða innrennslislyfið, lausnin er dökkt.
English: Genito-urinary tract infection (urinary tract infection, orchitis, epididymitis, cystitis).
Icelandic: Sýking í þvag- og kynfærum (þvagfærasýking, eistnabólga, lyppubólga, blöðrubólga).
English: NAME OF THE MEDICINAL PRODUCT TOOKAD 183 mg powder for solution for injection padeliporfin
Icelandic: TOOKAD 183 mg stungulyfsstofn, lausn padeliporfín
English: PHARMACEUTICAL FORM Powder for solution for injection.
Icelandic: Lyfjagjöf TOOKAD er til notkunar í bláæð.
English: NAME OF THE MEDICINAL PRODUCT TOOKAD 366 mg powder for solution for injection padeliporfin
Icelandic: TOOKAD 366 mg stungulyfsstofn, lausn padeliporfín
English: Pain
Icelandic: Mar
English: The study had two co-primary endpoints for TOOKAD-VTP in comparison to AS: - A: The rate of absence of definite cancer based on histology at 24 months, - B: The difference in rate of treatment failure associated with observed progression of disease from low to moderate or higher risk prostate cancer.
Icelandic: mánuði, - B: Munurinn á hlutfalli meðferðarbrests í tengslum við greinda versnun sjúkdóms frá lítilli hættu til miðlungs eða mikillar hættu á krabbameini í blöðruhálskirtli.
English: Characteristic
Icelandic: Aukaverkun
English: Sensory disturbance Formication
Icelandic: Settaugarbólga Skyntruflun Nálardofi (formication)
English: Haemorrhoids Anorectal discomfort Abdominal pain Rectal haemorrhage
Icelandic: Blæðing frá þvagleiðara Blæðing frá þvagrás
English: Uncommon side effects (may affect up to 1 in 100 people) - Dizziness, fall, - Headache, - Sensory disturbance, formication (sensation like crawling insects on or under the skin), - Eye irritation, photophobia (intolerance to light), - Dyspnoea exertional (excessive shortness of breath during or after exercise), - Mood disorder, - Weight decreased.
Icelandic: Sjaldgæfar aukaverkanir (geta komið fyrir hjá allt að 1 af hverjum 100 einstaklingum) - Sundl, föll, - Höfuðverkur, - Skyntruflun, nálardofi (að finnast skordýr skríða á sér eða undir húðinni), - Augnerting, ljósnæmi (óþol fyrir ljósi), - Áreynslumæði (mikil mæði við eða eftir æfingar), - Lyndisröskun, - Þyngdartap.
English: - You have undergone a procedure for treating benign prostatic hypertrophy including
Icelandic: - Ef þú hefur gengist undir meðferð við góðkynja stækkun á blöðruhálskirtli, þar með talið brottnámsaðgerð á blöðruhálskirtli um þvagrás (Trans-Urethral Resection of the Prostate
English: Dysuria (bladder pain, bladder spasm, hypertonic bladder, urethral spasm, urinary tract pain).
Icelandic: Þvaglátstregða (verkur í þvagblöðru, krampi í þvagblöðru, ofspennt þvagblaðra, krampi í þvagrás, verkur í þvagfærum).
English: Urinary retention immediately post procedure has been attributed to transient prostatic oedema and generally only short term recatheterisation was required.
Icelandic: Þvagteppa strax eftir aðgerðina hefur verið rakin til skammvinns bjúgs í blöðruhálskirtli sem krafðist einungis skammtíma ísetningu þvagleggs.
English: Muscular and connective tissue disorders
Icelandic: Segavarnarlyf og blóðflöguhemjandi lyf
English: See section 4.5 for interactions with photosensitizing medicinal products.
Icelandic: Upplýsingar um milliverkanir við ljósnæmandi lyf er að finna í kafla 4.5.
English: Unopened vial
Icelandic: Roði á inngjafarstað
English: Padeliporfin is retained within the vascular system.
Icelandic: - Virka innihaldsefnið er padeliporfín.
English: Allow the vial to rest in a vertical position for 3 minutes without further shaking or moving.
Icelandic: Endanleg styrkur lausnarinnar er 9,15 mg/mL. Leyfið hettuglasinu að hvíla í lóðréttri stöðu í 3 mínútur án frekari hristings eða hreyfingar.
English: Rash
Icelandic: Sundl
English: Perineal injury
Icelandic: LYFJAFORM OG INNIHALD
English: Micturition disorders
Icelandic: Ristruflanir
English: Urinary retention/urethral stricture
Icelandic: Stungulyfsstofn, lausn
English: Skin and subcutaneous tissue disorders
Icelandic: Sýkingar í þvag- og kynfærum
English: In a patient treated at 2 mg/kg of TOOKAD, one case of Grade 3 ischaemic optic neuropathy was reported 33 days after the VTP procedure.
Icelandic: Tilkynnt var um eitt tilvik sjóntaugakvilla af völdum blóðþurrðar 33 dögum eftir VTP aðgerðina hjá sjúklingi sem fékk meðferð með 2 mg/kg af TOOKAD.
English: Genital pain (penile pain, testicular pain, scrotal pain, non-infective orchitis, spermatic cord inflammation, genital contusion).
Icelandic: Verkur í kynfærum (verkur í getnaðarlim, verkur í eistum, verkur í pung, eistnabólga án sýkingar, bólga í kólfi, mar á kynfærum).
English: - You are having an exacerbation of rectal inflammatory bowel disease.
Icelandic: - Ef þú ert með versnandi bólgusjúkdóm í endaþarmi og þörmum.
English: For instructions on reconstitution of TOOKAD before administration, see section 6.6.
Icelandic: Sjá leiðbeiningar í kafla 6.6 um blöndun
English: Prostatic pain (prostatism, prostatic disorders, prostatic fibrosis).
Icelandic: Verkur í blöðruhálskirtli (hvekktruflun, kvillar í blöðruhálskirtli, bandvefsmyndun í blöðruhálskirtli).
English: AUTHORISATION
Icelandic: Geymsluskilyrði
English: Table 6: PCM301 - Effect on erectile function (IIEF) - ITT population and patients meeting the indication criteria
Icelandic: PCM301 - Áhrif á ristruflanir
English: Urethral stenosis Urinary incontinence
Icelandic: YTRI UMBÚÐUM YTRI ASKJA
English: America; 11 countries
Icelandic: Ameríku; 11 löndum
English: This appearance is normal
Icelandic: Það er eðlilegt útlit.
English: It is important that you follow the instructions of your doctor or nurse regarding return visits.
Icelandic: Mikilvægt er að þú fylgir fyrirmælum læknisins eða hjúkrunarfræðingsins varðandi endurkomu.
English: not less than 106.0 CCID50
Icelandic: ekki minna en 106.0 CCID50
English: As always, please take care to wash your hands thoroughly after changing soiled nappies.
Icelandic: Eins og alltaf skal þess gætt að þvo hendur vandlega eftir bleiuskipti.
English: South Africa, Malawi
Icelandic: Suður Afríka, Malaví
English: Natural fluctuations of the incidence of the disease may also influence the observed temporal effect.
Icelandic: Náttúrulegar sveiflur í tíðni sjúkdómsins geta einnig haft áhrif á áhrifin sem koma fram.
English: Sustained efficacy up to 3 years of age in Asia
Icelandic: Viðvarandi verkun í allt að 3 ár í Asíu
English: 10, 14 weeks and 6, 10, 14 weeks (Pooled)
Icelandic: 10, 14 vikna og 6, 10, 14 vikna (allir skammtar)
English: Rotarix should not be used in children over 24 weeks of age.
Icelandic: Rotarix á ekki að nota fyrir börn eldri en 24 vikna.
English: A minor infection such as a cold should not be a problem, but talk to your doctor first.
Icelandic: Minni háttar sýking eins og kvef ætti ekki að valda vandkvæðum, en ráðfærðu þig fyrst við lækninn.
English: • If the membrane has not been pierced return to section B and repeat steps 2, 3 and 4.
Icelandic: Ef himnan hefur ekki gatast skal fara aftur í hluta B og endurtaka skref 2, 3 og 4.
English: Not known*
Icelandic: Tíðni ekki þekkt*
English: 2, 3 months France,
Icelandic: 2, 3 mánaða Frakklandi,
English: Rotarix with food and drink
Icelandic: Notkun Rotarix með mat eða drykk
English: If you forget to go back to your doctor at the scheduled time, ask your doctor for advice.
Icelandic: Ef þú gleymir að fara aftur til læknisins á tilteknum tíma skaltu ráðfæra þig við lækninn.
English: 50 tubes
Icelandic: 50 túpur
English: • if your child has a severe infection with a high temperature.
Icelandic: ef barnið er með alvarlega sýkingu með háum hita.
English: * Because these events were reported spontaneously, it is not possible to reliably estimate their frequency.
Icelandic: * Þar sem tilkynningar um þessar aukaverkanir berast jafnóðum er ekki hægt að áætla tíðni þeirra á áreiðanlegan hátt.
English: If the reconstituted vaccine is not used within 24 hours, it should be discarded.
Icelandic: Ef fullbúið bóluefnið er ekki notað innan 24 klukkustunda skal því fleygt.
English: (cases/controls)
Icelandic: (tilvik/viðmið)
English: Bond et al. (2018) suggested some noncompliance to such recommendation in a recent conference abstract.
Icelandic: Bond et al. (2018) bentu á í nýlegu ágripi á ráðstefnu að ekki væri alltaf farið eftir þessum tilmælum.
English: Put back in fridge immediately
Icelandic: Setjið strax aftur í kæli
English: Your child will receive two doses of the vaccine.
Icelandic: Barnið fær tvo skammta af bóluefninu.
English: - This vaccine has been prescribed for your child only.
Icelandic: - Þessu bóluefni hefur verið ávísað eingöngu fyrir barnið.
English: Clinical studies from which efficacy data were derived were conducted in Europe, Central and South America, Africa and Asia (see section 5.1).
Icelandic: Klínískar rannsóknir á verkun voru gerðar í Evrópu, Mið- og Suður-Ameríku, Afríku og Asíu (sjá kafla 5.1).
English: Impact on hospitalisation§
Icelandic: Áhrif á innlagnir á sjúkrahús§
English: If not used immediately, in-use storage should not be longer than 24 hours and at a temperature between 2-25°C.
Icelandic: Ef bóluefnið er ekki notað strax skal það ekki geymt lengur en 24 klst. við hita á bilinu 2°C -25°C.
English: To separate one oral tube from the others starting at one end: a) Hold the tab of one of the end oral tubes to separate it from the others.
Icelandic: Til að aðskilja eina munngjafartúpu frá hinum með því að byrja á öðrum endanum: a) Haldið um flipann á einni af túpunni á endanum til að aðskilja hana frá hinum.
English: 2, 3 to 4 months
Icelandic: 2, 3 til 4 mánaða