FrancophonIA/ELRC3.0 huggingface dataset:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF ZYPREXA VELOTAB 20 mg ORODISPERSIBLE TABLETS
Icelandic: YTRI UMBÚÐUM ASKJA MEÐ ZYPREXA VELOTAB 20 mg MUNNDREIFITÖFLUR
English: 0.15 mg sodium methyl parahydroxybenzoate, 0.05 mg sodium propyl parahydroxybenzoate.
Icelandic: 0,15 mg natríum metýl parahýdroxýbenzóat 0,05 mg natríum própýl parahýdroxýbenzóat ZYPREXA VELOTAB 15 mg munndreifitöflur
English: If this happens after you have been given ZYPREXA VELOTAB tell your doctor.
Icelandic: ZYPREXA VELOTAB stendur skaltu hafa samband við lækninn þinn.
English: Syndrome
Icelandic: Einkenni
English: Drug
Icelandic: Framleiðandi
English: Dystonia (including oculogyration) 11
Icelandic: Truflun á vöðvaspennu (þar á meðal augnknattahreyfin gar)11
English: High Gamma
Icelandic: Mjög algengar Algengar
English: EU/1/99/125/003 28 orodispersible tablets EU/1/99/125/011 35 orodispersible tablets EU/1/99/125/007 56 orodispersible tablets EU/1/99/125/015 70 orodispersible tablets EU/1/99/125/019 98 orodispersible tablets
Icelandic: EU/1/99/125/003 28 munndreifitöflur EU/1/99/125/011 35 munndreifitöflur EU/1/99/125/007 56 munndreifitöflur EU/1/99/125/015 70 munndreifitöflur EU/1/99/125/019 98 munndreifitöflur
English: EU/1/99/125/004 28 orodispersible tablets EU/1/99/125/012 35 orodispersible tablets EU/1/99/125/008 56 orodispersible tablets EU/1/99/125/016 70 orodispersible tablets EU/1/99/125/020 98 orodispersible tablets
Icelandic: EU/1/99/125/004 28 munndreifitöflur EU/1/99/125/012 35 munndreifitöflur EU/1/99/125/008 56 munndreifitöflur EU/1/99/125/016 70 munndreifitöflur EU/1/99/125/020 98 munndreifitöflur
English: NAME OF THE MEDICINAL PRODUCT ZYPREXA VELOTAB 20 mg orodispersible tablets Olanzapine
Icelandic: ZYPREXA VELOTAB 20 mg munndreifitöflur Olanzapin
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF ZYPREXA VELOTAB 15 mg ORODISPERSIBLE TABLETS
Icelandic: YTRI UMBÚÐUM ASKJA MEÐ ZYPREXA VELOTAB 15 mg MUNNDREIFITÖFLUR
English: EU/1/99/125/001 28 orodispersible tablets EU/1/99/125/009 35 orodispersible tablets EU/1/99/125/005 56 orodispersible tablets EU/1/99/125/013 70 orodispersible tablets EU/1/99/125/017 98 orodispersible tablets
Icelandic: EU/1/99/125/001 28 munndreifitöflur EU/1/99/125/009 35 munndreifitöflur EU/1/99/125/005 56 munndreifitöflur EU/1/99/125/013 70 munndreifitöflur EU/1/99/125/017 98 munndreifitöflur
English: EU/1/99/125/002 28 orodispersible tablets EU/1/99/125/010 35 orodispersible tablets EU/1/99/125/006 56 orodispersible tablets EU/1/99/125/014 70 orodispersible tablets EU/1/99/125/018 98 orodispersible tablets
Icelandic: EU/1/99/125/002 28 munndreifitöflur EU/1/99/125/010 35 munndreifitöflur EU/1/99/125/006 56 munndreifitöflur EU/1/99/125/014 70 munndreifitöflur EU/1/99/125/018 98 munndreifitöflur
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF ZYPREXA VELOTAB 5 mg ORODISPERSIBLE TABLETS
Icelandic: YTRI UMBÚÐUM ASKJA MEÐ ZYPREXA VELOTAB 5 mg MUNNDREIFITÖFLUM
English: < 2.26 mmol/l) to high (≥ 2.26 mmol/l) were very common.
Icelandic: Breyting á fastandi þríglyseríðum frá jaðargildum í upphafi (< 1,69 mmól/l) - < 2,26 mmól/l) í há (< 2,26 mmól/l) var mjög algeng.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF ZYPREXA VELOTAB 10 mg ORODISPERSIBLE TABLETS
Icelandic: YTRI UMBÚÐUM ASKJA MEÐ ZYPREXA VELOTAB 10 mg MUNNDREIFITÖFLUM
English: 5 Observed for fasting normal levels at baseline (< 1.69 mmol/l) which increased to high
Icelandic: 5 Fastandi eðlileg gildi í upphafi (< 1,69 mmól/l) sem urðu há (≥ 2,26 mmól/l).
English: Fatigue
Icelandic: Frásog
English: *Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in sheep.
Icelandic: *RP (Relative Potency) = hlutfallsleg virkni mæld með virkniprófi hjá músum samanborið við viðmiðunarbóluefni sem sýnt hefur verið fram að á sé virkt í sauðfé.
English: ATCvet code: QI05AA10.
Icelandic: QI05AA10.
English: It is therefore recommended not to vaccinate foals of less than 6 months of age.
Icelandic: Því er mælt með að bólusetja ekki folöld yngri en 6 mánaða gömul.
English: EXPIRY DATE EXP {month/year}
Icelandic: FYRNINGARDAGSETNI NG EXP {mánuður/ár}
English: However, since the IgM response following vaccination is infrequent, a positive IgM-ELISA test result is a strong indicator of natural infection with West Nile virus.
Icelandic: Vegna þess að IgM-svörun eftir bólusetningu er hins vegar sjaldgæf, er jákvæð niðurstaða úr IgM-ELISA prófi sterk vísbending um náttúrulega sýkingu af vesturnílarveiru.
English: SP oil
Icelandic: SP olía
English: MARKETING AUTHORISATION NUMBERS EU/2/08/086/004-006
Icelandic: MARKAÐSLEYFISNÚMER EU/2/08/086/004-006
English: If such a reaction occurs, appropriate treatment should be administered without delay.
Icelandic: Ef slík einkenni koma fram, skal viðeigandi meðferð gefin án tafar.
English: • Primary vaccination course: first injection from 6 months of age, second injection 3-5 weeks later.
Icelandic: Frumbólusetningarlota: fyrsta inndæling eftir að 6 mánaða aldri er náð, önnur inndæling 3-5 vikum síðar.
English: • Revaccination: a sufficient degree of protection should be achieved after an annual booster injection with a single 1 ml dose although this schedule has not been fully validated.
Icelandic: Endurbólusetning: nægileg vörn ætti að nást eftir árlega örvunarbólusetningu með stökum 1 ml skammti, þó að sú bólusetningaráætlun hafi ekki verið fyllilega staðfest.
English: Administer the entire content of the syringe (1 ml), by deep intramuscular injection in the neck region, according to the following schedule:
Icelandic: Gefið allt innihald sprautunnar (1 ml) með inndælingu djúpt í vöðva á hálssvæðinu, samkvæmt eftirfarandi áætlun:
English: MARKETING AUTHORISATION NUMBER(S) EU/2/08/086/004 (2 single-dose glass syringes) EU/2/08/086/005 (4 single-dose glass syringes) EU/2/08/086/006 (10 single-dose glass syringes)
Icelandic: EU/2/08/086/004 (2 stakskammta sprautur úr gleri) EU/2/08/086/005 (4 stakskammta sprautur úr gleri) EU/2/08/086/006 (10 stakskammta sprautur úr gleri)
English: DATE OF THE REVISION OF THE TEXT Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Icelandic: DAGSETNING ENDURSKOÐUNAR TEXTANS Ítarlegar upplýsingar um þetta dýralyf eru birtar á heimasíðu Lyfjastofnunar Evrópu (http://www.ema.europa.eu/).
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Icelandic: Ákvörðun um að nota þetta bóluefni á undan eða eftir öðru dýralyfi verður því að taka í hverju tilviki fyrir sig.
English: The use of Equip WNV reduces the number of animals with viraemia after natural infection, but may not systematically prevent it.
Icelandic: Notkun á Equip WNV fækkar þeim hestum sem fá veirudreyra eftir náttúrulega sýkingu, en kemur hugsanlega ekki alfarið í veg fyrir hann.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Icelandic: 14. DAGSETNING SÍÐUSTU SAMÞYKKTAR FYLGISEÐILSINS Ítarlegar upplýsingar um þetta dýralyf eru birtar á heimasíðu Lyfjastofnunar Evrópu (http://www.ema.europa.eu).
English: In very rare cases transient hyperthermia may occur for up to 2 days.
Icelandic: Örsjaldan gæti líkamshiti hækkað í allt að 2 daga.
English: If infection is suspected as a result of a positive IgM response, additional testing would need to be conducted to conclusively determine whether the animal was infected or vaccinated.
Icelandic: Ef grunur leikur á sýkingu á grundvelli jákvæðrar IgM-svörunar, þyrfti að gera frekari próf til þess að skera á afgerandi hátt úr um hvort dýrið hafi sýkst eða verið bólusett.
English: No specific studies have been conducted to demonstrate absence of interferences from maternally derived antibodies on vaccine take.
Icelandic: Engar sértækar rannsóknir hafa verið gerðar til þess að sýna fram á að mótefni frá móður trufli ekki virkni bóluefnisins.
English: As a consequence, it cannot be excluded that transient immunodepression that may be observed during pregnancy could interfere with vaccine uptake.
Icelandic: Þar af leiðandi er ekki unnt að útiloka að tímabundin ónæmisbæling, sem gæti orðið vart meðan á meðgöngu stendur, geti truflað upptöku bóluefnisins.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Icelandic: Samkvæmt ákvæðum 71. greinar í tilskipun Evrópuráðsins og þingsins 2001/82/EB með viðaukum getur aðildarríki, í samræmi við löggjöf sína, bannað framleiðslu, innflutning, vörslu, sölu, dreifinguog/eða notkun ónæmislyfja á öllu yfirráðasvæði sínu eða hluta þess ef sýnt er að: a) Sé lyfið gefið dýrum muni það trufla framkvæmd innlendrar áætlunar er varðar greiningu,
English: Any person intending to manufacture, import, possess, sell, supply and use Equip WNV must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Icelandic: Sá sem ætlar að framleiða, flytja inn, hafa í sinni vörslu, selja, dreifa og/eða nota Equip WNV skal leita til viðkomandi yfirvalda til að fá upplýsingar um hvaða bólusetningarreglur gilda um dýr, áður en hafist er handa um framleiðslu, innflutning, vörslu, sölu, dreifingu og/eða notkun.
English: Packaging: box of 2, 4 or 10 single-dose syringes with needles.
Icelandic: Pakkningar: askja með 2, 4 eða 10 stakskammta sprautum með nálum.
English: The vaccine stimulates active immunity against West Nile virus.
Icelandic: Bóluefnið örvar virkt ónæmi gegn vesturnílarveiru.
English: RP* 1.0-2.2 * Relative potency by in vitro method, compared to a reference vaccine that was shown efficacious in horses.
Icelandic: RP* 1,0 - 2,2 *Hlutfallsleg virkni (RP - relative potency) með in vitro aðferð, samanborið við viðmiðunarbóluefni, sem hefur reynst hafa verkun hjá hestum.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21/11/2008
Icelandic: 21/11/2008 Nýjasta dagsetning endurnýjunar markaðsleyfis:
English: For the active immunisation of horses of 6 months of age or older against West Nile virus (WNV) disease by reducing the number of viraemic horses after infection with WNV lineage 1 or 2 strains and to reduce duration and severity of clinical signs against WNV of lineage 2 strains.
Icelandic: Til virkrar ónæmingar hesta 6 mánaða eða eldri gegn sjúkdómi af völdum vesturnílarveiru (WNV) með því að fækka hestum með veirudreyra eftir smit með WNV af stofni 1 eða 2 og til að draga úr lengd og alvarleika klínískra einkenna WNV af stofni 2.
English: Inactivated West Nile virus, strain VM-2
Icelandic: Óvirkjuð vesturnílarveira (WNV), stofn VM-2
English: Single-dose (1 ml) pre-filled type I glass syringe closed with bromobutyl rubber tip.
Icelandic: Áfyllt stakskammtasprauta (1 ml) úr gleri af tegund I, sem lokað er með hlíf úr brómóbútýl gúmmíi.
English: Minimum essential medium (MEM) Phosphate buffered saline
Icelandic: Saltlausn með fosfatbuffer
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box of 2, 4 or 10 single-dose pre-filled syringes
Icelandic: SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM Askja með 2, 4 eða 10 stakskammta áfylltum sprautum
English: As with any vaccine rare, occasional hypersensitivity reactions may occur.
Icelandic: Eins og við önnur bóluefni gætu stöku ofnæmisviðbrögð komið fram í mjög sjaldgæfum tilvikum.
English: Transient local reactions in the form of a mild, local swelling at the injection site post vaccination (maximum 1 cm in diameter) that resolve spontaneously within 1 to 2 days and that are sometimes associated with pain and mild depression were reported in very rare cases.
Icelandic: Örsjaldan hefur orðið vart við tímabundin, staðbundin viðbrögð sem lýsa sér sem vægur staðbundinn þroti á stungustað eftir bólusetningu (hámark 1 cm í þvermál) sem jafna sig af sjálfu sér á 1 til 2 dögum og sem stundum fylgir sársauki og vægt þunglyndi.
English: Inactivated West Nile virus, strain VM-2 (1.0-2.2 RP).
Icelandic: MAGN VIRKS INNIHALDSEFNIS/VIRKRA INNIHALDSEFNA Óvirkjuð vesturnílarveira (WNV), stofn VM-2 (RP = 1,0 - 2,2).
English: Onset of immunity: 3 weeks after primary vaccination course.
Icelandic: 3 vikum eftir grunnbólusetningarlotuna.
English: The manufacture, import, possession, sale, supply and/or use of Equip WNV may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Icelandic: Framleiðsla, innflutningur, varsla, sala, dreifing og/eða notkun Equip WNV er eða getur verið óheimil í aðildarríki, ýmist í ríkinu öllu eða hluta þess í samræmi við löggjöf þess.
English: Zoetis România S.R.L.
Icelandic: Zoetis România S.R.L. Tel:
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Icelandic: VIÐAUKI II A. FRAMLEIÐENDUR LÍFFRÆÐILEGRA VIRKRA EFNA OG FRAMLEIÐENDUR SEM ERU ÁBYRGIR FYRIR LOKASAMÞYKKT
English: Name and address of the manufacturer of the biological active substance: Zoetis Inc.
Icelandic: Heiti og heimilisfang framleiðanda líffræðilegs virks efnis:
English: a) The administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Icelandic: útrýmingu eða baráttu gegn dýrasjúkdómum, eða geri erfitt um vik að staðfesta að smit sé ekki til staðar í lifandi dýrum eða matvælum eða öðrum afurðum úr dýrum sem hafa fengið lyfið.
English: However, no specific efficacy studies were conducted in pregnant mares.
Icelandic: Hins vegar hafa engar sértækar rannsóknir verið gerðar hjá fylfullum hryssum.
English: Pharmacotherapeutic group: Immunologicals for Equidae, inactivated viral vaccines for horses.
Icelandic: Ónæmislyf fyrir hesta - bóluefni með óvirkjuðum veirum fyrir hesta.
English: No specific efficacy studies were conducted in pregnant mares.
Icelandic: Engar sértækar rannsóknir hafa verið gerðar hjá fylfullum hryssum.
English: MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Icelandic: FORSENDUR FYRIR, EÐA TAKMARKANIR Á, AFGREIÐSLU OG NOTKUN C. UPPLÝSINGAR
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Icelandic: - Mjög sjaldgæfar (koma fyrir hjá fleiri en 1 en færri en 10 af hverjum 10.000 dýrum).
English: RP* 1.0-2.2 *Relative potency by in vitro method, compared to a reference vaccine that was shown efficacious in horses.
Icelandic: Óvirkjuð vesturnílarveira (WNV), stofn VM-2 RP* 1,0 - 2,2 * Hlutfallsleg virkni (RP - relative potency) með in vitro aðferð, samanborið við viðmiðunarbóluefni, sem hefur reynst hafa verkun hjá hestum.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals: In case of accidental self-injection, ingestion or spillage onto skin, seek medical advice immediately and show the package leaflet or label to the physician.
Icelandic: Ef sá sem annast lyfjagjöf gefur sjálfum sér dýralyfið fyrir slysni, ef dýralyfið er óvart tekið inn, eða ef dýralyfið berst á húð fyrir slysni skal tafarlaust leita til læknis og hafa meðferðis fylgiseðil eða umbúðir dýralyfsins.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION For intramuscular use.
Icelandic: SKAMMTAR FYRIR HVERJA DÝRATEGUND, ÍKOMULEIÐ(IR)
English: PACKAGE LEAFLET FOR: Equip WNV emulsion for injection for horses
Icelandic: FYLGISEÐILL FYRIR: Equip WNV stungulyf, fleyti til notkunar handa hestum
English: Shelf life of the veterinary product as packaged for sale: pre-filled glass syringe: 2 years.
Icelandic: Geymsluþol dýralyfsins í söluumbúðum: áfyllt sprauta úr gleri:
English: For WNV lineage 2 strains the duration of immunity has not been established.
Icelandic: 12 mánuðir eftir grunnbólusetningarlotuna fyrir WNV af stofni 1. Fyrir WNV af stofni 2 hefur tímalengd ónæmis ekki verið staðfest.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Single dose syringe
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á LITLUM
English: Following the administration of a double dose of vaccine, no adverse reactions other than those described under section 4.6 have been observed.
Icelandic: 4.10 Ofskömmtun (einkenni, bráðameðferð, móteitur) ef þörf krefur Eftir gjöf tvöfalds bóluefnisskammts hefur ekki orðið vart neinna annarra aukaverkana en lýst var í kafla 4.6.
English: SPECIAL WARNING(S) Special precautions for use in animals: Vaccinate healthy animals only.
Icelandic: Sérstakar varúðarreglur við notkun hjá dýrum:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equip WNV injection for horses
Icelandic: Equip WNV stungulyf handa hestum.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES 1 ml contains:
Icelandic: VIRK(T) INNIHALDSEFNI OG ÖNNUR INNIHALDSEFNI 1 ml inniheldur:
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Icelandic: - Koma örsjaldan fyrir (koma fyrir hjá færri en 1 af hverjum 10.000 dýrum, þ.m.t. einstök tilvik).
English: Magyarország Zoetis Hungary Kft. Tel: +361 224 5222
Icelandic: Luxembourg / Luxemburg Zoetis Belgium SA Tél/Tel.: +352 8002 4026
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intramuscular use.
Icelandic: AÐFERÐ VIÐ LYFJAGJÖF OG ÍKOMULEIÐ(IR)
English: PACKAGE SIZE 2 single-dose syringes 4 single-dose syringes 10 single-dose syringes
Icelandic: PAKKNINGASTÆRÐ 2 stakskammta sprautur.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equip WNV emulsion for injection for horses
Icelandic: HEITI DÝRALYFS Equip WNV stungulyf, fleyti handa hestum.
English: TARGET SPECIES Horses
Icelandic: Áfyllt sprauta úr gleri af tegund
English: <ANNEX IV
Icelandic: Viðauki IV
English: <the applicant could establish in the application that the medicinal product, although similar to <authorised orphan medicinal product>, is safer, more effective or otherwise clinically superior (as defined in Article 3 of Commission Regulation (EC) No. 847/2000) for the same therapeutic indication>.
Icelandic: <umsækjandinn sýnir fram á það í umsókninni að þrátt fyrir að lyfið samsvari {heiti sérlyfs með markaðsleyfi við fátíðum sjúkdómi} er það öruggara, hefur meiri verkun eða aðra klíníska yfirburði (skv. skilgreiningu í 3. grein reglugerðar framkvæmdastjórnarinnar (EB) nr. 847/2000) við sömu ábendingu> <og>
English: [Art 74(a)- legal status switch]<Furthermore, the CHMP reviewed the data submitted by the Marketing Authorisation Holder, taking into account the provisions of Article 74(a) of Directive 2001/83/EC, and considers that the data submitted in support of the classification of {specify medicinal product name} as ‘medicinal product not subject to medical prescription' were significant as further explained in the European Public Assessment Report.>
Icelandic: Enn fremur fór CHMP yfir gögnin sem markaðsleyfishafinn lagði fram og tók tillit til ákvæða í grein 74(a) í tilskipun Evrópuþingsins og ráðsins 2001/83/EB og telur að gögnin sem lögð voru fram til að styðja flokkun {heiti sérlyfs} sem lyf sem er ekki lyfseðilsskylt séu þýðingarmikil eins og nánar er útskýrt í opinberu evrópsku matsskýrslunni.>
English: CONCLUSIONS ON <SIMILARITY AND DEROGATION> <AND> < THE REQUEST FOR ONE-YEAR <MARKETING PROTECTION> <DATA EXCLUSIVITY>> PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Icelandic: <og> <ósk um eins árs <markaðsvernd> <gagnavernd>>
English: It may harm them,
Icelandic: P-glýkóprótein hemlar
English: Talk to your doctor if you are not sure.
Icelandic: Ræddu við lækni þinn ef þú ert ekki viss.
English: N/A = Not Applicable
Icelandic: N/A = Á ekki við (not applicable)
English: On average, 94% of the dose was recovered within 17 days.
Icelandic: Að meðaltali endurheimtust 94% skammtsins innan 17 daga.
English: Grade (CTC-AE)*
Icelandic: Stig (CTC-AE)*
English: The majority of events were Grade 1 or 2 and non-serious.
Icelandic: Meirihluti tilvika var af alvarleikastigi 1 eða 2 og ekki alvarlegur.
English: Each pack contains 63 tablets.
Icelandic: Hver pakkning inniheldur 63 töflur.
English: ^ Data cut-off date of 19 September 2014
Icelandic: Gagnasnið tekið 19. september 2014
English: Patients should be closely monitored.
Icelandic: Fylgjast á vandlega með sjúklingum.
English: Continue to take Cotellic as normal, the next day.
Icelandic: Haltu áfram að taka Cotellic eins og venjulega næsta dag.
English: Study NO25395 (BRIM7)
Icelandic: NO25395 rannsóknin (BRIM7)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1048/001
Icelandic: MARKAÐSLEYFISNÚMER EU/1/15/1048/001
English: · Take the tablets every day for 21 days (called a “treatment period”).
Icelandic: · Taktu töflurnar á hverjum degi í 21 dag (þetta tímabil nefnist „meðferðarlota“).
English: All Grades Grades 3-4 All Grades Grades 3-4
Icelandic: Öll stig Stig 3-4 Öll stig Stig 3-4
English: Transparent PVC/PVDC blisters containing 21 tablets.
Icelandic: Gegnsæjar PVC/PVDC þynnur með 21 töflu.
English: Your doctor will do blood tests to monitor for this.
Icelandic: Læknirinn mun taka blóðsýni til að fylgjast með þessu.
English: Malta (see Ireland)
Icelandic: Malta (See United Kingdom)
English: Cotellic with food and drink
Icelandic: Notkun Cotellic með mat eða drykk
English: · After the 21 days, do not take any Cotellic tablets for 7 days.
Icelandic: · Eftir 21 dag átt þú ekki að taka Cotellic töflur næstu 7 daga.
English: Grade 1 or Grade 2 (tolerable)
Icelandic: 1. stig eða 2. stig (þolanlegt)
English: Mortality occurred in juvenile animals at a dose (3 mg/kg) which did not lead to mortalities in adult animals.
Icelandic: Dauðsföll komu fyrir hjá ungum dýrum við skammta (3 mg/kg) sem ekki leiddu til dauðsfalla hjá fullorðnum dýrum.
English: Interrupt treatment for 4 weeks
Icelandic: Gera á hlé á meðferð í 4 vikur
English: The transport across the blood brain barrier is unknown.
Icelandic: Flutningur þess yfir blóð-heila þröskuld er óþekktur.
English: The magnitude of interaction could potentially be lower in patients.
Icelandic: Umfang milliverkunarinnar gæti verið minna hjá sjúklingum.
English: The median follow up was 14.2 months.
Icelandic: Miðgildi eftirfylgni var 14,2 mánuðir.
English: · Cotellic can be taken with or without food.
Icelandic: · Cotellic má taka með eða án fæðu.
English: This is because it could increase the amount of Cotellic in your blood.
Icelandic: Þetta er vegna þess að það gæti aukið magn Cotellic í blóði þínu.
English: g The data cut-off date for the final OS analysis is 28 August 2015 and median follow-up was 18.5 months.
Icelandic: g Gagnasnið fyrir greiningu á endanlegri heildarlifun var tekið 28. ágúst 2015 og miðgildi eftirfylgni var 18,5 mánuðir.
English: Before starting treatment, your doctor will test for this mutation.
Icelandic: Áður en meðferð er hafin mun læknirinn rannsaka hvort þú ert með þessa stökkbreytingu.
English: Your doctor will do blood tests to check these amounts and monitor how well your liver is working.
Icelandic: Læknirinn mun taka blóðsýni til að mæla magn þeirra og fylgjast með því hve vel lifur þín starfar.