FrancophonIA/ELRC3.0 huggingface dataset:
English: After oral administration of the veterinary medicinal product to cats at the recommended therapeutic dose, absorption of pradofloxacin is rapid, reaching peak concentrations of 2.1 mg/l within 1 hour.
Icelandic: Eftir gjöf ráðlagðs meðferðarskammts af dýralyfinu með inntöku hjá köttum frásogast pradofloxacin hratt og nær hámarksþéttninni 2,1 mg/l á innan við 1 klst.
English: J.E.
Icelandic: z o.o.
English: Pradofloxacin induced eye malformations at foetal and maternal toxic doses in rats.
Icelandic: Pradofloxacin olli vansköpun á augum í eitrunarskömmtum fyrir fóstur og móður hjá rottum.
English: PACKAGE LEAFLET: Veraflox 60 mg and 120 mg tablets for dogs
Icelandic: 60 mg og 120 mg töflur handa hundum
English: Mild transient gastro-intestinal disturbances including vomiting have been observed in rare cases in dogs and cats.
Icelandic: Í mjög sjaldgæfum tilvikum hafa sést væg, tímabundin einkenni frá meltingarfærum, þar með talin uppköst hjá hundum og köttum.
English: 4.2 Indications for use, specifying the target species Treatment of:
Icelandic: 4.2 Ábendingar fyrir tilgreindar dýrategundir Meðferð við:
English: Due to potential harmful effects, the tablets must be kept out of the sight and reach of children.
Icelandic: Geymið töflurnar þar sem börn hvorki ná til né sjá vegna hugsanlegra skaðlegra áhrifa þeirra.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 15 mg pradofloxacin.
Icelandic: VIRK(T) INNIHALDSEFNI Hver tafla inniheldur 15 mg pradofloxacin.
English: Cross-resistance within the fluoroquinolone class of antimicrobials is common.
Icelandic: Kross-ónæmi milli flúórókínólón sýklalyfja er algengt.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Aluminium blister of 7 tablets (120 mg)
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á ÞYNNUM EÐA STRIMLUM Álþynna með 7 töflum (120 mg)
English: Therefore, Veraflox should not be administered concurrently with antacids, sucralfate, multivitamins or dairy products, as absorption of Veraflox may be decreased.
Icelandic: Veraflox með sýrubindandi lyfjum, sucralfati, fjölvítamínum eða mjólkurvörum vegna þess að frásog Veraflox getur minnkað.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Veraflox 15 mg tablets for dogs and cats pradofloxacin
Icelandic: 15 mg töflur handa hundum og köttum pradofloxacin
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Aluminium blister of 7 tablets (15 mg)
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á ÞYNNUM EÐA STRIMLUM Álþynna með 7 töflum (15 mg)
English: Magyarország Bayer Hungária Kft. HU-1123 Budapest
Icelandic: Magyarország Bayer Hungária Kft.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Veraflox 60 mg tablets for dogs Veraflox 120 mg tablets for dogs pradofloxacin
Icelandic: 60 mg töflur handa hundum Veraflox 120 mg töflur handa hundum pradofloxacin
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated-) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Icelandic: - Mjög algengar (aukaverkanir koma fyrir hjá fleiri en 1 af hverjum 10 dýrum sem fá meðferð ) - Algengar (koma fyrir hjá fleiri en 1 en færri en 10 af hverjum 100 dýrum sem fá meðferð) - Sjaldgæfar (koma fyrir hjá fleiri en 1 en færri en 10 af hverjum 1.000 dýrum sem fá meðferð) - Mjög sjaldgæfar (koma fyrir hjá fleiri en 1 en færri en 10 af hverjum 10.000 dýrum sem fá meðferð)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 60 mg pradofloxacin.
Icelandic: VIRK(T) INNIHALDSEFNI Hver tafla inniheldur 60 mg pradofloxacin.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Aluminium blister of 7 tablets (60 mg)
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á ÞYNNUM EÐA STRIMLUM Álþynna með 7 töflum (60 mg)
English: Official and local antimicrobial policies should be taken into account when the product is used.
Icelandic: Hafa skal hliðsjón af opinberum og staðbundnum leiðbeiningum um notkun sýklalyfja þegar dýralyfið er notað.
English: The combined use of fluoroquinolones with digoxin should also be avoided because of potentially increased oral bioavailability of digoxin.
Icelandic: Einnig skal forðast samtímis notkun flúórókínólóna með dígóxíni vegna hugsanlegrar aukningar á aðgengi dígoxíns við inntöku.
English: Fertility:
Icelandic: Tlf:
English: Pradofloxacin is eliminated from serum with a terminal half-life of 7 hours.
Icelandic: Helmingunartími brotthvarfs pradofloxacins úr sermi er 7 klst.
English: • wound infections and abscesses caused by susceptible strains of Pasteurella multocida and the
Icelandic: Bráðum sýkingum í efri öndunarvegum af völdum næmra stofna Pasteurella multocida,
English: In cats, absorption of orally administered pradofloxacin at the therapeutic dose is rapid reaching peak concentrations of 1.2 mg/l within 0.5 hours.
Icelandic: Eftir gjöf meðferðarskammts af lyfinu með inntöku hjá köttum frásogast pradofloxacin hratt og nær hámarksþéttninni 1,2 mg/l á innan við 0,5 klst.
English: ADVICE ON CORRECT ADMINISTRATION The oral suspension should be given by direct oral administration as shown below:
Icelandic: LYFJAGJÖF Gefa skal mixtúruna beint í munn eins og sýnt er hér að neðan:
English: MARKETING AUTHORISATION NUMBER EU/2/10/107/014
Icelandic: MARKAÐSLEYFISNÚMER EU/2/10/107/014
English: Česká republika Tel: +420 2 66 10 14 71
Icelandic: CZ-155 00 Praha 5 Tel: +420 2 66 10 14 71
English: Interactions with other medicinal products and other forms of interaction: There are some medicines that you should not give to your animal during treatment because if given together they might cause serious adverse effects.
Icelandic: Sum lyf má ekki gefa dýrinu þínu sem samhliða meðferð þar sem það getur valdið alvarlegum aukaverkunum.
English: The duration of treatment depends on the severity of the infection and how well the medicine works in your pet. For most infections the following durations of treatment are recommended:
Icelandic: Meðferðarlengd fer eftir eðli og alvarleika sýkingar og hversu vel lyfið virkar fyrir dýrið.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Folding carton containing a HDPE bottle (30 ml oral suspension)
Icelandic: YTRI UMBÚÐUM Pappaaskja sem inniheldur HDPE glas ( 30 ml mixtúra, dreifa)
English: The treatment should be reconsidered if no improvement of the clinical condition is observed within 3 days after starting the treatment.
Icelandic: Endurmeta skal meðferðina hafi ekki náðst neinn bati innan 3 daga eftir að meðferðin hófst.
English: In case of gingivitis and periodontitis, Veraflox should only be used as an adjunct to mechanical or surgical periodontal therapy.
Icelandic: Við tannholds- og tannslíðursbólgu skal einungis nota Veraflox sem viðbótarmeðferð við tannhreinsun eða skurðaðgerð á tannholdi.
English: MARKETING AUTHORISATION NUMBER EU/2/10/107/013
Icelandic: MARKAÐSLEYFISNÚMER EU/2/10/107/013
English: Do not use in dogs during the period of growth as developing articular cartilage may be affected.
Icelandic: Ekki má nota lyfið handa hundum á vaxtarskeiði þar sem lyfið getur haft áhrif á myndun liðbrjósks.
English: Use of the veterinary medicinal product deviating from instructions given in the summary of product characteristics (SPC) may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other fluoroquinolones due to the potential for crossresistance.
Icelandic: Ef brugðið er út frá leiðbeiningum um notkun dýralyfsins eins og lýst er í samantekt á eiginleikum lyfs (SPC) getur það aukið útbreiðslu baktería sem eru ónæmar fyrir flúórókínólónum og getur dregið út áhrifum meðferðar með öðrum flúórókínólónum vegna hugsanlegs kross- ónæmis.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/10/107/001-012
Icelandic: MARKAÐSLEYFISNÚMER EU/2/10/107/001-012
English: However the product should not be used in cats with persisting articular cartilage lesions, as these lesions may worsen during treatment with fluoroquinolones.
Icelandic: Samt sem áður má ekki nota lyfið handa köttum með viðvarandi liðbrjóskskemmdir, vegna þess að skemmdirnar geta aukist við meðferð með flúórókínólónum.
English: Do not use in dogs with persisting articular cartilage lesions, since lesions may worsen during treatment with fluoroquinolones.
Icelandic: Ekki má nota lyfið handa hundum með viðvarandi liðbrjóskskemmdir, vegna þess að skemmdirnar geta aukist við meðferð með flúórókínólónum.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Folding carton containing a HDPE bottle (15 ml oral suspension)
Icelandic: YTRI UMBÚÐUM Pappaaskja sem inniheldur HDPE glas ( 15 ml mixtúra, dreifa)
English: The treatment should be re-considered if no improvement of the clinical condition is observed within 3 days after starting the treatment.
Icelandic: Endurmeta skal meðferðina hafi ekki náðst neinn bati innan 3 daga eftir að meðferð hófst.
English: (kg)
Icelandic: ÁBENDING(AR)
English: The safety of Veraflox has not been established during pregnancy and lactation in dogs.
Icelandic: Ekki hefur verið sýnt fram á öryggi dýralyfsins á meðgöngu og við mjólkurgjöf hjá læðum.
English: Further, fluoroquinolones should not be used in combination with non-steroidal anti-inflammatory drugs (NSAIDs) in animals with a history of seizures because of potential pharmacodynamic interactions in the CNS.
Icelandic: Ekki má heldur nota flúórókínólóna með bólgueyðandi verkjalyfjum (NSAID-lyfjum) hjá dýrum með sögu um krampa vegna hugsanlegra lyfjahvarfafræðilegra milliverkana í miðtaugakerfi.
English: Do not use in cats with central nervous system (CNS) disorders, such as epilepsy, as fluoroquinolones could potentially cause seizures in predisposed animals.
Icelandic: Ekki má nota lyfið handa köttum með miðtaugakerfisraskanir, t.d. flogaveiki, vegna þess að flúórókínólónar geta hugsanlega valdið krömpum hjá móttækilegum dýrum.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Veraflox 15 mg tablets pradofloxacin
Icelandic: 15 mg töflur pradofloxacin
English: Staphylococcus intermedius group (including S. pseudintermedius).
Icelandic: Staphylococcus intermedius (þar með talið S. pseudintermedius).
English: Do not use in dogs with central nervous system (CNS) disorders, such as epilepsy, as fluoroquinolones could possibly cause seizures in predisposed animals.
Icelandic: Ekki má nota lyfið handa hundum með miðtaugakerfisraskanir, t.d. flogaveiki, vegna þess að flúórókínólónar geta valdið krömpum hjá móttækilegum dýrum.
English: Ask your veterinarian for advice if no improvement of the clinical condition is observed within 3 days after starting the treatment.
Icelandic: Ráðfærðu þig við dýralækninn ef ekki hefur náðst neinn bati innan 3 daga eftir að meðferð hófst.
English: Due to potential harmful effects, the bottle and the filled syringes must be kept out of the sight and reach of children.
Icelandic: Sérstakar varúðarreglur fyrir þann sem gefur dýrinu lyfið Geymið glösin og áfylltu sprauturnar þar sem börn hvorki ná til né sjá vegna hugsanlegra skaðlegra áhrifa lyfsins.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Veraflox 120 mg tablets for dogs pradofloxacin
Icelandic: HEITI DÝRALYFS Veraflox 120 mg töflur handa hundum pradofloxacin
English: Intermittent vomiting was observed after repeated oral administration of 1.6 times the maximum recommended dose.
Icelandic: Uppköst sem koma sjaldan hafa sést hjá köttum eftir endurteknar lyfjagjafir sem nema 1,6 földum ráðlögðum hámarksskammti.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Oral suspension containing 25 mg/ml pradofloxacin Preservative: Sorbic acid (E200) 2 mg/ml
Icelandic: VIRKT INNIHALDSEFNI OG ÖNNUR INNIHALDSEFNI Mixtúra, dreifa sem inniheldur pradofloxacin 25 mg/ml.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Veraflox 120 mg tablets pradofloxacin
Icelandic: HEITI DÝRALYFS Veraflox 120 mg töflur pradofloxacin
English: Staphylococcus intermedius group (including S. pseudintermedius)
Icelandic: Staphylococcus intermedius flokkur (þar með talið S. pseudintermedius)
English: Pasteurella multocida, Escherichia coli and the Staphylococcus intermedius group (including S. pseudintermedius).
Icelandic: Escherichia coli og Staphylococcus intermedius (þar með talið S pseudintermedicus).
English: PACKAGE LEAFLET: Veraflox 25 mg/ml oral suspension for cats
Icelandic: HEITI DÝRALYFS Veraflox 25 mg/ml mixtúra, dreifa handa köttum
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Folding carton containing 1 blister strip (1 x 7 tablets of 120 mg) Folding carton containing 3 blister strips (3 x 7 tablets of 120 mg) Folding carton containing 10 blister strips (10 x 7 tablets of 120 mg) Folding carton containing 20 blister strips (20 x 7 tablets of 120 mg)
Icelandic: Pappaaskja sem inniheldur 20 þynnur (20 x 7 töflur 120 mg)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Veraflox 25 mg/ml oral suspension for cats pradofloxacin
Icelandic: Veraflox 25 mg/ml mixtúra, dreifa handa köttum pradofloxacin
English: MARKETING AUTHORISATION NUMBER(S) EU/2/10/107/013-014
Icelandic: MARKAÐSLEYFISNÚMER EU/2/10/107/013-014
English: Magnesium stearate Silica, colloidal anhydrous Artificial beef flavour Croscarmellose sodium
Icelandic: Magnesíumsterat Vatnsfrí kísilkvoða Gervi nautakjötsbragðefni Natríumcroscarmellósa
English: Dosages
Icelandic: ÁBENDINGAR
English: This veterinary medicinal product should only be used in severe cases of periodontal disease.
Icelandic: Einungis skal nota dýralyfið við svæsnum tilfellum af sjúkdómum í tannholdi.
English: Number of strains
Icelandic: Fjöldi stofna
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Folding carton containing 1 blister strip (1 x 7 tablets of 60 mg) Folding carton containing 3 blister strips (3 x 7 tablets of 60 mg) Folding carton containing 10 blister strips (10 x 7 tablets of 60 mg) Folding carton containing 20 blister strips (20 x 7 tablets of 60 mg)
Icelandic: Pappaaskja sem inniheldur 3 þynnur (3 x 7 töflur 60 mg)
English: Amberlite IRP 64 Sorbic acid Ascorbic acid Xanthan gum Propylene glycol Vanilla flavour Purified water
Icelandic: Xanthangúmmí Própýlenglýkól Vanillubragðefni (samtengt) Hreinsað vatn
English: Treatment of: • acute infections of the upper respiratory tract caused by susceptible strains of Pasteurella multocida, Escherichia coli and the Staphylococcus intermedius group (including S. pseudintermedius).
Icelandic: Sárasýkingum og graftarkýlum af völdum næmra stofna Pasteurella multocida og Staphylococcus intermedius stofna (þar með talið S. pseudointermedicus).
English: Not applicable.
Icelandic: Ekki hefur verið sýnt fram á
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Veraflox 60 mg tablets pradofloxacin
Icelandic: 60 mg töflur pradofloxacin
English: • as adjunctive treatment to mechanical or surgical periodontal therapy in the treatment of severe infections of the gingiva and periodontal tissues caused by susceptible strains of anaerobic organisms, for example Porphyromonas spp.
Icelandic: Við alvarlegri tannholds- og tannslíðursbólgu af völdum næmra stofna loftfælinna örvera, t.d. Porphyromonas spp. og Prevotella spp.
English: In case of gingivitis and periodontitis, the veterinary medicinal product should only be used as an adjunct to mechanical or surgical periodontal therapy.
Icelandic: Við tannholds- og tannslíðursbólgu skal einungis nota dýralyfið sem viðbótarmeðferð við tannhreinsun eða skurðaðgerð á tannholdi.
English: Marketing authorisation holder : Bayer Animal Health GmbH D-51368 Leverkusen Germany
Icelandic: MARKAÐSLEYFISHAFI Bayer Animal Health GmbH D-51368 Leverkusen Þýskaland.
English: Mild transient gastro-intestinal disturbances including vomiting have been observed in rare cases.
Icelandic: Í mjög sjaldgæfum tilvikum hafa sést væg, tímabundin einkenni frá meltingarfærum, þar með talin uppköst.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Veraflox 60 mg tablets for dogs pradofloxacin
Icelandic: 60 mg töflur handa hundum pradofloxacin
English: BE-1831 Diegem (Machelen) Belgique/Belgien Tél/Tel: +32 2 535 65 22
Icelandic: FI-20101 Turku/Åbo Puh/Tel: +358 10 4261
English: For dogs over 15 kg, use 60 mg or 120 mg pradofloxacin tablets.
Icelandic: Notið 60 mg eða 120 mg pradofloxacin töflur fyrir hunda sem vega meira en 15 kg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Folding carton containing 1 blister strip (1 x 7 tablets of 15 mg) Folding carton containing 3 blister strips (3 x 7 tablets of 15 mg) Folding carton containing 10 blister strips (10 x 7 tablets of 15 mg) Folding carton containing 20 blister strips (20 x 7 tablets of 15 mg)
Icelandic: Pappaaskja sem inniheldur 20 þynnur (20 x 7 töflur 15 mg)
English: Staphylococcus intermedius group (including S. pseudintermedius) and
Icelandic: Staphylococcus intermedius (þar með talið S. pseudintermedius),
English: • superficial and deep pyoderma caused by susceptible strains of the Staphylococcus intermedius group (including S. pseudintermedius),
Icelandic: Sárasýkingum og sýkingum af völdum næmra stofna Staphylococcus intermedius (þar með talið S.
English: • acute infections of the upper respiratory tract caused by susceptible strains of Pasteurella multocida, Escherichia coli and the Staphylococcus intermedius group (including S. pseudintermedius).
Icelandic: Bráðum þvagfærasýkingum af völdum næmra stofna Escherichia coli og Staphylococcus intermedius (þar með talið S. pseudintermedius) og
English: Adjuvant MF59C.1 containing squalene (9.75 milligrams), polysorbate 80 (1.175 milligrams), sorbitan trioleate (1.175 milligrams)
Icelandic: 1 inniheldur skvalen (9,75 milligrömm), pólýsorbat 80 (1,175 milligrömm), sorbítan tríóleat (1,175 milligrömm)
English: 1 Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/California/7/2009 (H1N1)v like strain used (X-179A)
Icelandic: A/California/7/2009 (H1N1)v líkur stofn (X-179A)
English: Strength Pharmaceutica l Form
Icelandic: Styrkur Lyfjaform Íkomuleið
English: 10 multidose vials
Icelandic: 10 áfylltar sprautur
English: * propagated in eggs ** expressed in microgram haemagglutinin.
Icelandic: *ræktað í eggjum **tjáð í míkrógrömmum hemagglútiníns.
English: Packagin
Icelandic: Heiti
English: EU Number
Icelandic: EMEA-verkefnisnúmer
English: 10 pre-filled syringes vial (glass) 5.0 ml
Icelandic: 5,0 ml (1 skammtur = 0,5 ml)
English: Solvent: 10 ml Matrix: 2 x (2.5 x 5 cm)
Icelandic: Netja: 2 x (2.5 x 5 cm)
English: 1 vial + 1 vial + 2 matrices + 2 syringes + 2 needles
Icelandic: + 1 netja + 2 sprautur + 2 nálar
English: Solvent: 10 ml Matrix: 7.5 x 10 cm
Icelandic: 7.5 x 10 cm
English: Immediate Packaging
Icelandic: Pakkningast ærð
English: <Content (concentration)>
Icelandic: (Sér)heiti
English: Route of administration
Icelandic: Styrklei ki
English: Days 1-21
Icelandic: Dagur 1-21
English: Your doctor will discuss these with you and will explain the risks and benefits of your treatment.
Icelandic: Læknirinn mun ræða við þig um aukaverkanirnar og útskýra áhættuna og ávinninginn af meðferðinni.
English: None reported
Icelandic: Engar tilkynntar
English: Other symptoms may occur as well.
Icelandic: Önnur einkenni geta einnig komið fram.
English: ATC code: L01XC23.
Icelandic: L01XC23.
English: IRC assessment was performed post-hoc.
Icelandic: IRC mat var gert eftirá.
English: The minimum follow-up was 70.6 months.
Icelandic: Lágmarks eftirfylgni var 70,6 mánuðir.
English: Do not try to treat your symptoms with other medicines.
Icelandic: Ekki reyna að meðhöndla einkennin með öðrum lyfjum.
English: Age < 65 years ≥ 65 years
Icelandic: Aldur < 65 ára > 65 ára
English: Paracetamol (650-1000 mg orally).
Icelandic: Paracetamól (650-1000 mg til inntöku).
English: The lyophilised powder should dissolve in less than 10 minutes.
Icelandic: Frostþurrkaða duftið á að leysast upp á innan við 10 mínútum.
English: Rate (incidence rate/100 patient years)
Icelandic: Tíðni (tíðni tilvika/100 sjúklingaár)
English: Empliciti is used if your cancer has not responded to, or has come back after certain treatments.
Icelandic: Empliciti er notað ef krabbameinið hefur ekki svarað meðferð eða hefur komið aftur eftir ákveðna meðferð
English: Children and adolescents Empliciti is not recommended for use in children and adolescents aged under 18 years.
Icelandic: Empliciti er ekki ætlað börnum og unglingum yngri en 18 ára.
English: See Table 8 and Figure 2.
Icelandic: Sjá töflu 8 og mynd
English: If the infusion reaction recurs, the Empliciti infusion must be stopped and not restarted on that day (see section 4.4).
Icelandic: Ef innrennslisviðbrögð koma aftur fram verður að stöðva Empliciti innrennsli og hefja það ekki aftur þann daginn (sjá kafla 4.4).
English: Grade 3/4
Icelandic: Stig 3/4
English: Neutralizing antibodies were detected in 19 of 299 patients in CA204004.
Icelandic: Hlutleysandi mótefni greindust hjá 19 af 299 sjúklingum í CA204004.
English: More than one vial of Empliciti may be needed to give the total dose for the patient.
Icelandic: Fleiri en eitt hettuglas af Empliciti getur þurft til að fá heildarskammt fyrir sjúklinginn.
English: What Empliciti is and what it is used for 2.
Icelandic: Upplýsingar um Empliciti og við hverju það er notað 2.
English: Feeling tired or weak
Icelandic: Þreyta eða máttleysi
English: No dose adjustment is required for Empliciti in patients over 65 years of age (see section 5.2).
Icelandic: Ekki þarf að aðlaga skammta Empliciti hjá sjúklingum eldri en 65 ára (sjá kafla 5.2).
English: European Group for Blood and Marrow Transplantation (EBMT) criteria.
Icelandic: Viðmið EBMT (European Group for Blood and Marrow Transplantation).
English: Tell your doctor or nurse straight away if you feel unwell during infusion.
Icelandic: Látið lækninn eða hjúkrunarfræðinginn tafarlaust vita ef þér líður illa á meðan innrennsli stendur.
English: The most serious adverse reaction that may occur during elotuzumab treatment is pneumonia.
Icelandic: Alvarlegasta aukaverkunin sem getur komið fram meðan á meðferð með elotuzumabi stendur er lungnabólga.
English: The pre-planned final OS analysis was performed after 212 deaths in the E-Ld arm and 225 deaths in the Ld arm.
Icelandic: Fyrirframáætluð endanleg greining á heildarlifun var gerð eftir 212 dauðsföll hjá E-Ld hópnum og 225 dauðsföll hjá Ld hópnum.
English: Eleven (9.4%) patients had high-risk myeloma.
Icelandic: Ellefu (9,4%) sjúklinga voru með hááhættu mergæxli.
English: It is not known, whether elotuzumab passes into breast milk or if there is any risk to the breast-fed infant.
Icelandic: Ekki er þekkt hvort elotuzumab skilst út í brjóstamjólk eða hvort það er hætta fyrir börn sem eru á brjósti.
English: Dexamethasone was administered on day 1, 8, 15 and 22 of each cycle.
Icelandic: Dexamethason var gefið dag 1, 8, 15 og 22 í hverri lotu.
English: Do not stop treatment unless you have discussed this with your doctor.
Icelandic: Ekki má hætta meðferðinni án þess að ræða við lækninn.
English: All reports of infusion reaction were ≤ Grade 3.
Icelandic: Öll tilvik innrennslisviðbragða voru ≤ 3 stigs.
English: Grade 3 infusion reactions occurred in 1% of patients.
Icelandic: 3. stigs innrennslisviðbrögð komu fram hjá 1% sjúklinga.
English: How much Empliciti is given The amount of Empliciti you will be given will be calculated based on your body weight.
Icelandic: Empliciti á að gefa Magn Empliciti sem þú færð er reiknað út frá líkamsþyngd.
English: When the symptoms go away or improve, the infusion can be continued more slowly and speeded up gradually if the symptoms do not recur.
Icelandic: Þegar einkennin hverfa eða batna má halda innrennslinu áfram hægar og hraða því smám saman ef einkennin koma ekki til baka.
English: A total of 40 (67%) patients were alive in the E-Pd arm and 29 (51%) in the Pd arm.
Icelandic: Alls voru 40 (67%) sjúklingar á lífi í E-Pd hópnum og 29 (51%) í Pd hópnum.
English: Date of first authorisation: 11 May 2016
Icelandic: 11. maí 2016.
English: In these 19 patients, anti-product antibodies occurred within the first 2 months of the initiation of Empliciti treatment.
Icelandic: Af þessum 19 sjúklingum komu mótefni gegn lyfinu fram fyrstu 2 mánuði Empliciti meðferðar.