FrancophonIA/ELRC3.0 huggingface dataset:
English: Abbreviations: CI=confidence interval; EGFR=epidermal growth factor receptor; HR=hazard ratio; IRC=independent radiologic central; ITT=Intent-to-treat; IWRS=interactive web response system; N/n=total number; NSCLC=non-small cell lung cancer; PFS=progression-free survival; DoR=Duration of Response.
Icelandic: CI=öryggisbil; EGFR=húðþekjuvaxtarþáttaviðtaki; HR=áhættuhlutfall; IRC=óháð geislalækningamiðstöð; ITT=þýði sem á að meðhöndla; IWRS= gagnvirkt viðbragðskerfi á vefnum; N/n=heildarfjöldi; NSCLC=lungnakrabbamein sem er ekki af smáfrumugerð; PFS=lifun án versnunar sjúkdóms; DoR=endingartími svörunar.
English: The median time to the first episode of any grade of transaminases increased was approximately 12 weeks and the median time to the worst episode of transaminases increased was 12 weeks in patients receiving dacomitinib.
Icelandic: Miðgildi tíma fram að fyrsta tilviki um hækkun transamínasa var u.þ.b. 12 vikur og miðgildi tíma fram að versta tilviki um hækkun transamínasa var 12 vikur hjá sjúklingum sem fengu dacomitinib.
English: * Fatal events were reported.
Icelandic: * Greint var frá dauðsföllum.
English: • For Grade 2 diarrhoea, if not improved to Grade ≤ 1 within 24 hours while using anti-diarrhoeal medicinal products (e.g., loperamide) and adequate oral fluid intake, withhold dacomitinib.
Icelandic: Við 2. stigs niðurgang, skáni hann ekki og breytist í ≤ 1. stigs niðurgang innan sólarhrings meðan notuð eru stemmandi lyf (t.d. lóperamíð) og við næga inntöku vökva, skal ekki gefa dacomitinib.
English: Grade 3
Icelandic: Tafla 3.
English: Pharmacotherapeutic group: Anti-neoplastic agents, protein kinase inhibitors, ATC code: L01XE47
Icelandic: Æxlishemjandi lyf, próteinkínasahemlar, ATC-flokkur:
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium-free”.
Icelandic: Lyfið inniheldur minna en 1 mmól (23 mg) af natríum í hverjum skammti, þ.e.a.s. er sem næst natríumlaust.
English: • Flushed or painful palms or soles
Icelandic: Roði eða sárauki í lófum eða iljum
English: Polyvinyl alcohol - partially hydrolysed (E1203)
Icelandic: Pólývinýl alkóhól - vatnsrofið að hluta (E1203) Talkúm (E553b)
English: Initiate or continue treatment and/or provide additional treatment (e.g., broad spectrum oral or intravenous antibiotics and topical steroids).
Icelandic: Hefja skal meðferð eða veita viðbótarmeðferð (t.d. með breiðvirkum sýklalyfjum til inntöku eða í æð og staðbundinni steranotkun).
English: Median DoR in months (95% CI) HR (95% CI)
Icelandic: Miðgildi endingartíma svörunar í mánuðum (95% CI)
English: • If you are being treated with any of the medicines listed in section Other medicines and Vizimpro.
Icelandic: Ef þú færð meðferð með einhverjum þeirra lyfja sem talin eru upp í kaflanum
English: Therefore, the statistical significance of OS improvement could not be formally assessed.
Icelandic: Þess vegna var ekki hægt að meta formlega tölfræðilega marktækni bættrar heildarlifunar (OS).
English: Thus, dacomitinib is not expected to be genotoxic at clinically relevant exposure concentrations.
Icelandic: Því er ekki gert ráð fyrir að dacomitinib hafi eiturverkun á erfðaefni við útsetningu við meðferðarþéttni.
English: Efficacy results from ARCHER 1050 in patients with previously untreated NSCLC with EGFR-activating mutations - ITT population Dacomitinib N=227
Icelandic: Niðurstöður verkunar í ARCHER 1050 rannsókninni hjá sjúklingum sem ekki höfðu áður fengið meðferð við NSCLC með virkjandi stökkbreytingar EGFRITT þýði
English: Start oral antibiotics and topical steroids in patients who develop exfoliative skin conditions.
Icelandic: Hefja skal notkun sýklalyfja til inntöku og staðbundna notkun steralyfja hjá sjúklingum sem fá húðflögnun.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Icelandic: Einnig er hægt að tilkynna aukaverkanir beint samkvæmt því fyrirkomulagi sem gildir í hverju landi fyrir sig, sjá Appendix V.
English: Subgroup analyses of PFS per IRC review based on baseline characteristics were consistent with those from the primary analysis of PFS.
Icelandic: Greiningar hjá undirhópum á lifun án versnunar sjúkdóms (PFS) skv. IRC mati byggt á eiginleikum í upphafi voru í samræmi við þær sem fengust í frumgreiningu á PFS.
English: Stratification factors at randomisation were race (Japanese versus mainland Chinese versus other East Asian versus non-East Asian, as stated by the patient), and EGFR mutation status (exon 19 deletion versus the L858R mutation in exon 21).
Icelandic: Kína samanborið við aðra frá Austur-Asíu samanborið við þá sem ekki voru frá Austur-Asíu, samkvæmt því sem sjúklingar gáfu upp), og staða stökkbreytinga í EFGR (brottfall í táknröð 19 samanborið við L858R stökkbreytingu í táknröð 21).
English: The median time to the first episode of any grade exfoliative skin conditions was 6 weeks and the median time to the worst episode of exfoliative skin conditions was 6 weeks.
Icelandic: Miðgildi tíma fram að fyrsta tilviki um húðflögnun af hvaða stigi sem er var 6 vikur og miðgildi tíma fram að versta tilviki um húðflögnun 6 vikur.
English: Upon recovery, resume dacomitinib with a reduction of 1 dose level.
Icelandic: Þegar bata er náð skal byrja aftur notkun dacomitinibs með minnkun um 1 skammtastærð.
English: Fertility studies have not been performed with dacomitinib.
Icelandic: Engar rannsóknir hafa verið gerðar á áhrifum dacomitinibs á frjósemi.
English: No clear relationship between dacomitinib exposure and efficacy could be characterised over the exposure range studied.
Icelandic: Ekki var unnt að skilgreina skýrt samband milli útsetningar fyrir dacomitinibi og verkunar miðað við þá útsetningu sem var rannsökuð.
English: What you need to know before you take Vizimpro 3.
Icelandic: Áður en byrjað er að nota Vizimpro 3. Hvernig nota á Vizimpro
English: Grade 4
Icelandic: Tafla 4.
English: Treat with anti-diarrhoeal medicinal products (e.g., loperamide), and adequate oral fluid intake or intravenous fluids or electrolytes as appropriate.
Icelandic: Gefið stemmandi lyf (t.d. lóperamíð) og nægan vökva til inntöku eða vökva eða saltlausn í æð eftir því sem við á.
English: • Peeling skin
Icelandic: Flagnandi húð
English: Initiate treatment (e.g., antibiotics, topical steroids, and emollients).
Icelandic: Hefja skal meðferð (t.d. með sýklalyfjum, staðbundinni steranotkun og mýkjandi áburði).
English: Second dose reduction
Icelandic: Seinni skammtaminnkun
English: Decreased appetite Hypokalaemiaa
Icelandic: Minnkuð matarlyst
English: Dacomitinib should not be used during pregnancy.
Icelandic: Ekki má nota dacomitinib á meðgöngu.
English: INFORMATION IN BRAILLE Vizimpro 30 mg
Icelandic: Vizimpro 30 mg
English: Vizimpro 45 mg film-coated tablets
Icelandic: Vizimpro 45 mg filmuhúðaðar töflur
English: In humans, dacomitinib undergoes oxidation and glutathione conjugation as the major metabolic pathways.
Icelandic: Hjá mönnum eru aðalumbrotsleiðir dacomitinibs oxun og glútaþíón-samtenging.
English: Developmental toxicity
Icelandic: Eiturverkanir á þroskun
English: Diarrhoea, including severe diarrhoea, has been very commonly reported during treatment with Vizimpro (see section 4.8).
Icelandic: Mjög algengt er að greint sé frá niðurgangi, þar með talinn verulegur niðurgangur meðan á meðferð með Vizimpro stendur (sjá kafla 4.8).
English: Concomitant use of proton pump inhibitors (PPIs) with dacomitinib should be avoided (see section 4.5).
Icelandic: Forðast skal samhliða gjöf prótónpumpuhemla (PPI) og dacomitinibs (sjá kafla 4.5).
English: Repeated-dose toxicity
Icelandic: Eiturverkun vegna endurtekinna skammta
English: The stratification factors were Race (Japanese vs mainland Chinese and other East Asian vs non-East Asian) and EGFR mutation status (exon 19 deletion vs the L858R mutation in exon 21) at randomisation per IWRS.
Icelandic: Kína og aðrir frá Austur-Asíu samanborið við ekki frá Austur-Asíu) og staða EGFR stökkbreytinga (brottfall táknraðar 19 á samanborið við L858R stökkbreyting í táknröð 21) við slembiröðun skv.
English: • Nausea or vomiting
Icelandic: Ógleði eða uppköst
English: Palmar-plantar erythrodysaesthesia syndrome
Icelandic: Handa-fótaheilkenni
English: Vizimpro 30 mg film-coated tablets
Icelandic: Vizimpro 30 mg filmuhúðaðar töflur
English: INFORMATION IN BRAILLE Vizimpro 45 mg
Icelandic: Vizimpro 45 mg
English: Limited pharmacokinetic data are available in patients with severe renal impairment (CrCl < 30 mL/min) (N=4).
Icelandic: Takmörkuð gögn liggja fyrir um lyfjahvörf hjá sjúklingum með verulega (CrCl < 30 ml/mín.; N=4) skerta nýrnastarfsemi.
English: INFORMATION IN BRAILLE Vizimpro 15 mg
Icelandic: Vizimpro 15 mg
English: Treatment with Vizimpro should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Icelandic: Læknir með reynslu af gjöf krabbameinslyfja skal hefja og hafa yfirumsjón með meðferð með Vizimpro.
English: Initiate treatment or provide additional treatment (e.g., oral antibiotics and topical steroids).
Icelandic: Hefja skal meðferð eða veita viðbótarmeðferð (t.d. með sýklalyfjum til inntöku og staðbundinni steranotkun).
English: Vizimpro 45 mg film-coated tablets are supplied as blue film-coated, round biconvex tablet, debossed with “Pfizer” on one side and “DCB45” on the other.
Icelandic: - Vizimpro 45 mg filmuhúðaðar töflur eru fáanlegar sem bláar, kringlóttar, tvíkúptar filmuhúðaðar töflur, þrykktar með „Pfizer“ öðru megin og „DCB45“ hinum megin.
English: The median time to the first episode of any grade diarrhoea was 1 week and the median time to the worst episode of diarrhoea was 2 weeks in patients receiving dacomitinib.
Icelandic: Miðgildi tíma fram að fyrsta tilviki um niðurgang á hvaða stigi sem er var 1 vika og miðgildi tíma fram að versta tilviki um niðurgang var 2 vikur hjá sjúklingum sem fengu dacomitinib.
English: Based on population pharmacokinetic analyses, mild (60 mL/min ≤ CrCl < 90 mL/min; N=590) and moderate (30 mL/min ≤ CrCl < 60 mL/min; N=218) renal impairment, did not alter dacomitinib pharmacokinetics, relative to subjects with normal (CrCl ≥ 90 mL/min; N=567) renal function.
Icelandic: ≤ CrCl < 60 ml/mín.; N=218) skert nýrnastarfsemi ekki lyfjahvörfum dacomitinibs,
English: Vizimpro 15 mg film-coated tablets
Icelandic: Vizimpro 15 mg filmuhúðaðar töflur
English: Each film-coated tablet contains dacomitinib monohydrate equivalent to 30 mg dacomitinib.
Icelandic: Hver filmuhúðuð tafla inniheldur dacomitinib einhýdrat, samsvarandi 30 mg dacomitinib.
English: Data based on pool of 255 patients who received Vizimpro 45 mg once daily as starting dose for first-line treatment of NSCLC with EGFR-activating mutations across clinical studies.
Icelandic: Vizimpro 45 mg einu sinni á sólarhring í upphafsskammt sem fyrsta val við meðferð á lungnakrabbamein sem er ekki af smáfrumugerð (NSCLC) og virkjandi stökkbreytingar í húðþekjuvaxtarþáttaviðtaka (EGFR) í öllum klínískum rannsóknum.
English: Vizimpro 30 mg film-coated tablets are supplied as blue film-coated, round biconvex tablet, debossed with “Pfizer” on one side and “DCB30” on the other.
Icelandic: - Vizimpro 30 mg filmuhúðaðar töflur eru fáanlegar sem bláar, kringlóttar, tvíkúptar filmuhúðaðar töflur, þrykktar með „Pfizer“ öðru megin og „DCB30“ hinum megin.
English: Palmar-plantar erythrodysaesthesia syndrome Skin fissures Dry skin f
Icelandic: Laktósaeinhýdrat Örkristallaður sellulósi Natríumsterkjuglýkólat
English: Blue film-coated, 7.5 mm, round biconvex tablet, debossed with “Pfizer” on one side and “DCB30” on the other.
Icelandic: Blá 7,5 mm, kringlótt, tvíkúpt filmuhúðuð tafla, þrykkt með „Pfizer“ öðru megin og „DCB30“ hinum megin.
English: Each film-coated tablet contains dacomitinib monohydrate equivalent to 45 mg dacomitinib.
Icelandic: Hver filmuhúðuð tafla inniheldur dacomitinib einhýdrat, samsvarandi 45 mg dacomitinib.
English: h Nail disorder includes the following PTs: Ingrowing nail, Nail bed bleeding, Nail bed inflammation, Nail discolouration, Nail disorder, Nail infection, Nail toxicity, Onychoclasis, Onycholysis, Onychomadesis, Paronychia.
Icelandic: Naglakvilli felur einnig í sér eftirfarandi kjörhugtök: inngróin nögl, blæðing úr naglböndum, bólga í naglbeði, mislitun nagla, naglakvilli, naglasýking, eiturverkun í nöglum, brotnar neglur, nagllos, naglmissir, naglgerðisbólga.
English: PPIs should be avoided while receiving treatment with dacomitinib (see section 4.4).
Icelandic: Forðast skal notkun prótónpumpuhemla á meðan á meðferð með dacomitinibi stendur (sjá kafla 4.4).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 45 mg dacomitinib (as dacomitinib monohydrate).
Icelandic: Hver filmuhúðuð tafla inniheldur 45 mg dacomitinib (sem dacomitinib einhýdrat).
English: • For Grade ≥ 3 rash, erythematous or exfoliative skin conditions, withhold dacomitinib.
Icelandic: Við ≥ 3. stigs útbrot, hörundsroða eða húðflögnun, skal ekki gefa dacomitinib.
English: Stomatitis e
Icelandic: VIÐAUKI I
English: Blue film-coated, 9.0 mm, round biconvex tablet, debossed with “Pfizer” on one side and “DCB45” on the other.
Icelandic: Blá 9,0 mm, kringlótt, tvíkúpt filmuhúðuð tafla, þrykkt með „Pfizer“ öðru megin og „DCB45“ hinum megin.
English: EXPIRY DATE EXP
Icelandic: EXP
English: e Stomatitis includes the following PTs: Aphthous ulcer, Cheilitis, Dry mouth, Mucosal inflammation, Mouth ulceration, Oral pain, Oropharyngeal pain, Stomatitis.
Icelandic: Munnbólga felur einnig í sér eftirfarandi kjörhugtök: munnangur, varabólga, munnþurrkur, slímhúðarbólga, sár í munni, verkur í munni, verkur í munnkoki, munnbólga.
English: NAME OF THE MEDICINAL PRODUCT Vizimpro 30 mg tablets dacomitinib
Icelandic: Vizimpro 30 mg töflur dacomitinib
English: Diarrhoea* Stomatitis d
Icelandic: Millivefslungnasjúkdómur*
English: What is in this leaflet
Icelandic: Bólga í augum
English: • Withhold dacomitinib during ILD/Pneumonitis diagnostic evaluation.
Icelandic: Ekki gefa dacomitinib meðan greiningarmat fyrir millivefslungnasjúkdóm/lungnabólgu fer fram.
English: Each film-coated tablet contains dacomitinib monohydrate equivalent to 15 mg dacomitinib.
Icelandic: Hver filmuhúðuð tafla inniheldur dacomitinib einhýdrat, samsvarandi 15 mg dacomitinib.
English: Blue film-coated, 6.35 mm, round biconvex tablet, debossed with “Pfizer” on one side and “DCB15” on the other.
Icelandic: Blá 6,35 mm, kringlótt, tvíkúpt filmuhúðuð tafla, þrykkt með „Pfizer“ öðru megin og „DCB15“ hinum megin.
English: Dacomitinib showed a clearance of 20.0 L/hr with an inter-individual variability of 32% (CV%).
Icelandic: með 32% fráviksstuðul (CV%) milli einstaklinga.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 30 mg dacomitinib (as dacomitinib monohydrate).
Icelandic: Hver filmuhúðuð tafla inniheldur 30 mg dacomitinib (sem dacomitinib einhýdrat).
English: Dry skin includes the following PTs: Dry skin, Xerosis.
Icelandic: Húðþurrkur felur einnig í sér eftirfarandi kjörhugtök: húðþurrkur, vefþurrkur.
English: NAME OF THE MEDICINAL PRODUCT Vizimpro 45 mg tablets dacomitinib
Icelandic: Vizimpro 45 mg töflur dacomitinib
English: NAME OF THE MEDICINAL PRODUCT Vizimpro 15 mg tablets dacomitinib
Icelandic: Vizimpro 15 mg töflur dacomitinib
English: 2-sided p-valueb
Icelandic: 6.2 Ósamrýmanleiki
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Icelandic: Lýsing á útliti Vizimpro og pakkningastærðir
English: Local antacids and H2 receptor antagonists may be used if needed.
Icelandic: Nota má sýrubindandi lyf með staðbundna verkun og H2-viðtakablokka ef þörf krefur.
English: Rash may occur or worsen in areas exposed to sun. Sun protection with protective clothing and sunscreen is recommended.
Icelandic: Útbrot geta komið fram eða versnað á svæðum sem sólin skín á.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 15 mg dacomitinib (as dacomitinib monohydrate).
Icelandic: Hver filmuhúðuð tafla inniheldur 15 mg dacomitinib (sem dacomitinib einhýdrat).
English: • Hair loss
Icelandic: Naglakvilli Hármissir
English: Dysgeusia
Icelandic: Dacomitinib
English: The median duration of any grade and Grade ≥ 3 exfoliative skin conditions was 10 weeks and approximately 2 weeks, respectively.
Icelandic: Miðgildi tímalengdar fyrir hvaða stig sem er af húðflögnun var 10 vikur og fyrir ≥ 3. stigs var það u.þ.b. 2 vikur.
English: c Interstitial lung disease includes the following PTs: Interstitial lung disease, Pneumonitis.
Icelandic: Millivefslungnasjúkdómur felur einnig í sér eftirfarandi kjörhugtök: millivefslungnasjúkdómur, lungnabólga.
English: In faeces, dacomitinib, O-desmethyl dacomitinib, a cysteine conjugate of dacomitinib, and a mono-oxygenated metabolite of dacomitinib were the major drug-related components.
Icelandic: Í hægðum voru helstu lyfjatengdu þættirnir dacomitinib, O-desmetýl dacomitinib, sýstein-samtengt dacomitinib og einsúrefnisbundið umbrotsefni
English: Interstitial lung disease (ILD)/Pneumonitis
Icelandic: Lifun án versnunar sjúkdóms (skv. ICR)
English: • For Grade 1 diarrhoea, no dose modification is required.
Icelandic: Við húðflögnun á 1. stigi er ekki þörf á skammtabreytingum.
English: i Nail disorder includes the following PTs: Ingrowing nail, Nail discolouration, Nail disorder, Nail infection, Nail toxicity, Onychoclasis, Onycholysis, Onychomadesis, Paronychia.
Icelandic: Naglakvilli felur einnig í sér eftirfarandi kjörhugtök: inngróin nögl, mislitun nagla, naglakvilli, naglasýking, eiturverkun í nöglum, brotnar neglur, nagllos, naglmissir, naglgerðisbólga.
English: What Vizimpro looks like and contents of the pack Vizimpro 15 mg film-coated tablets are supplied as blue film-coated, round biconvex tablets, debossed with “Pfizer” on one side and “DCB15” on the other.
Icelandic: - Vizimpro 15 mg filmuhúðaðar töflur eru fáanlegar sem bláar, kringlóttar, tvíkúptar filmuhúðaðar töflur, þrykktar með „Pfizer“ öðru megin og „DCB15“ hinum megin.
English: • The recommended dose is 45 mg taken by mouth each day.
Icelandic: Ráðlagður skammtur er 45 mg á sólarhring til inntöku.
English: NAME OF THE MEDICINAL PRODUCT Vizimpro 30 mg film-coated tablets dacomitinib
Icelandic: Vizimpro 30 mg filmuhúðaðar töflur dacomitinib
English: Initiate treatment (e.g., oral antibiotics and topical steroids).
Icelandic: Hefja skal meðferð (t.d. með sýklalyfjum til inntöku og staðbundinni steranotkun).
English: Dacomitinib binds selectively and irreversibly to its HER family targets thereby providing prolonged inhibition.
Icelandic: 21. Dacomitinib binst valkvætt og óafturkræft við marksvæði sem er innan HER viðtaka-fjölskyldunnar og veitir þar með langvarandi hemlun.
English: NAME OF THE MEDICINAL PRODUCT Vizimpro 45 mg film-coated tablets dacomitinib
Icelandic: Vizimpro 45 mg filmuhúðaðar töflur dacomitinib
English: Gastrointestinal disorders Diarrhoea d
Icelandic: Dreifing lifunar án versnunar sjúkdóms
English: • For Grade 1 rash or erythematous skin conditions, no dose modification is required.
Icelandic: Við útbrot eða hörundsroða á 1. stigi er ekki þörf á skammtabreytingum.
English: 662) and 0.889 (95% CI: 0.568, 1.391), respectively.
Icelandic: Lagskipt HR-0,589 (95% CI: 0,469; 0,739) Lagskipt log-rank p-gildi (tvíhliða) < 0,0001
English: • Weight loss
Icelandic: Skammtastærð
English: Nail disorder h
Icelandic: B. FYLGISEÐILL
English: NAME OF THE MEDICINAL PRODUCT Vizimpro 15 mg film-coated tablets dacomitinib
Icelandic: Vizimpro 15 mg filmuhúðaðar töflur dacomitinib
English: Encourage adequate oral fluid intake during diarrhoea.
Icelandic: Hvetja skal til nægrar inntöku vökva þegar niðurgangur er til staðar.
English: e Rash (also referred to as Rash and erythematous skin conditions) includes the following PTs: Acne, Dermatitis acneiform, Erythema, Erythema multiforme, Rash, Rash erythematous, Rash generalised, Rash macular, Rash maculo-papular, Rash papular.
Icelandic: Útbrot (einnig nefnt útbrot og hörundsroði) felur einnig í sér eftirfarandi kjörhugtök: gelgjubólur, húðbólga með graftarbólum, hörundsroði, regnbogaroði, útbrot, roðaútbrot, útbreidd útbrot, dröfnuútbrot, dröfnuörðuútbrot, örðuútbrot.
English: Skin and subcutaneous tissue disorders Rash f
Icelandic: Handa-fótaheilkenni Sprungur í húð Húðþurrkur Kláði
English: Initiate treatment with anti-diarrhoeal medicinal products (e.g., loperamide) at first onset of diarrhoea.
Icelandic: Hefja skal meðferð með stemmandi lyfjum (t.d. lóperamíð) um leið og vart verður við niðurgang.
English: The median time to the first episode of any grade rash and erythematous skin conditions was approximately 2 weeks and the median time to the worst episode of rash and erythematous skin conditions was 7 weeks in patients receiving dacomitinib.
Icelandic: 2 vikur og miðgildi tíma fram að versta tilviki um útbrot og hörundsroða var 7 vikur hjá sjúklingum sem fengu dacomitinib.
English: Indigo Carmine Aluminium Lake (E132)
Icelandic: Indigótín (E132)
English: i Skin exfoliation (also referred to as Exfoliative skin conditions) includes the following PTs: Exfoliative rash, Skin exfoliation.
Icelandic: Húðflögnun felur einnig í sér eftirfarandi kjörhugtök: flagningsútbrot, húðflögnun.
English: Duration of Response in Responders (per IRC) Number of responders per IRC review, n
Icelandic: IRC mati, n (%)
English: 2-sided p-valuec
Icelandic: VIRK(T) EFNI
English: PHARMACEUTICAL FORM AND CONTENTS 30 film-coated tablets
Icelandic: 30 filmuhúðaðar töflur
English: Dacomitinib should be administered 2 hours before or at least 10 hours after taking H2 receptor antagonists.
Icelandic: H2-viðtakablokka eða a.m.k. 10 klst. eftir töku
English: Dacomitinib was clastogenic in the in vitro human lymphocyte chromosome aberration assay at cytotoxic concentrations.
Icelandic: Dacomitinib olli litningaskemmdum í in vitro frávikaprófi á litningum úr eitilfrumum manna við frumudrepandi þéttni.
English: Pruritus g
Icelandic: VIÐAUKI III
English: Conjunctivitis includes the following PTs: Blepharitis, Conjunctivitis, Dry eye, Noninfective conjunctivitis.
Icelandic: Tárubólga felur einnig í sér eftirfarandi kjörhugtök: hvarmaþroti, tárubólga, augnþurrkur, tárubólga án sýkingar.
English: In embryo-foetal development studies in rats and rabbits, pregnant animals received oral doses up to approximately 2.4 times and 0.3 times, respectively, the unbound AUC at the recommended human dose during the period of organogenesis.
Icelandic: 2,4 sinnum og 0,3 sinnum, í sömu röð, óbundið AUC í ráðlögðum skömmtum fyrir menn á tímabili líffæramyndunar.
English: 2 pre-filled syringes + 2 alcohol pads
Icelandic: 2 áfylltar sprautur + 2 sprittþurrkur
English: 75 mg Solution for injection
Icelandic: 75 mg
English: Subcutaneous use Pre-filled syringe (glass)
Icelandic: Áfyllt sprauta (gler)
English: MA EU Number (Invented) name
Icelandic: ESB markaðsleyfisnúmer (Sér)heiti
English: ATCvet code: QI05AI01.
Icelandic: QI05AI01.
English: 10x1 ml (10 doses).
Icelandic: 10x1 ml (10 skammtar).
English: Date of first authorisation: 6/03/2003 Date of last renewal: 6/03/2013
Icelandic: Dagsetning fyrstu útgáfu markaðsleyfis: 06/03/2003 Nýjasta dagsetning endurnýjunar markaðsleyfis: 06/03/2013
English: Only healthy animals should be vaccinated.
Icelandic: Aðeins skal bólusetja heilbrigð dýr.
English: One dose of 1 ml contains:
Icelandic: Hver 1 ml skammtur inniheldur:
English: Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest FRANCE
Icelandic: Porte des Alpes Rue de l'Aviation 69800 Saint Priest FRAKKLAND
English: Onset of immunity: 14 days after primary vaccination course.
Icelandic: 14 dögum eftir grunnbólusetningu (primary vaccination course).
English: • A transient swelling which usually regresses within 4 days may appear at the injection site.
Icelandic: Tímabundinn þroti, sem yfirleitt gengur til baka innan 4 daga, getur komið fram á stungustað.
English: After inoculation, the viruses do not multiply in the horse but express the protective proteins.
Icelandic: Eftir bólusetningu fjölgar veiran sér ekki í hestinum, en hún tjáir verndandi próteinin.
English: Tetanus component: MERIAL Toulouse 4, chemin du Calquet 31057 Toulouse Cedex FRANCE
Icelandic: MERIAL Toulouse 4, chemin du Calquet 31057 Toulouse Cedex Frakkland