FrancophonIA/ELRC3.0 huggingface dataset:
English: Median annual factor consumption was 5572 IU/kg (min 3849, max 7035) in Study I and 4456 IU/kg (min 3563, max 8011) in Study III.
Icelandic: Miðgildi árlegrar notkunar storkuþáttar var 5.572 IU/kg (að lágmarki 3.849, að hámarki 7.035) í rannsókn I og 4.456 IU/kg (að lágmarki 3.563, að hámarki 8.011) í rannsókn III.
English: ELOCTA 500 IU powder and solvent for solution for injection
Icelandic: ELOCTA 500 IU stungulyfsstofn og leysir, lausn
English: On-demand treatment: Median annual factor consumption was 1039 IU/kg (min 280, max 3571) for 23 patients randomised to the on-demand treatment arm in Study I and 671 IU/kg (min 286, max 913) for 6 patients remaining on on-demand treatment for at least one year in Study III.
Icelandic: Miðgildi árlegrar notkunar storkuþáttar var 1.039 IU/kg (að lágmarki 280, að hámarki 3.571) hjá 23 sjúklingum sem slembiraðað var í fyrirbyggjandi meðferðararminn í rannsókn
English: After reconstitution, each mL of solution for injection contains approximately 83 IU efmoroctocog alfa.
Icelandic: Eftir blöndun inniheldur hver ml af stungulyfi, lausn u.þ.b. 83 IU af efmoroctocog alfa.
English: Can be stored at room temperature (up to 30°C) for a single period up to 6 months.
Icelandic: Má geyma við stofuhita (allt að 30°C) eitt samfellt tímabil í allt að 6 mánuði.
English: Respective median ABR was 1.92 (min 0, max 7.1) and 1.25 (min 0, max 9.5).
Icelandic: Miðgildi árlegrar heildarblæðingartíðni var 1,92 (að lágmarki 0, að hámarki 7,1) og 1,25 (að lágmarki 0, að hámarki 9,5) í þessari röð.
English: Recording of batch number
Icelandic: Skráning lotunúmers
English: Incremental Recovery (IU/dL per IU/kg)
Icelandic: Stigvaxandi heimtur (IU/dl á IU/kg)
English: Solvent for ELOCTA water for injections
Icelandic: Lyfjahvarfabreytur fyrir ELOCTA með notkun á einföldu storkuprófi
English: Your doctor will calculate your dose of ELOCTA (in International Units or “IU”) depending on your individual needs for factor VIII replacement therapy and on whether it is used for prevention or treatment of bleeding.
Icelandic: Læknirinn mun reikna út skammtinn af ELOCTA (í alþjóðlegum einingum eða „IU“).
English: Hypertension Hot flush Angiopathy2
Icelandic: Leysir: vatn f. stungulyf
English: The Table 2 presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Icelandic: MedDRA flokkun eftir líffærum (flokkun eftir líffærum og ákjósanleg heiti).
English: It is strongly recommended that every time ELOCTA is given, the name and batch number of the product are recorded.
Icelandic: Skráning Eindregið er mælt með því að skrá heiti og lotunúmer lyfsins í hvert skipti sem ELOCTA er gefið.
English: Respective median Annualized Bleed Rate (ABR) was 0.00 (min 0, max 10.5) and 1.18 (min 0, max 9.2).
Icelandic: Miðgildi árlegrar heildarblæðingartíðni var 0,00 (að lágmarki 0, að hámarki 10,5) og 1,18 (að lágmarki 0, að hámarki 9,2) í þessari röð.
English: Contents of the pack and other information What ELOCTA contains
Icelandic: Hvernig geyma á ELOCTA Pakkningar og aðrar upplýsingar
English: ELOCTA 750 IU powder and solvent for solution for injection Each vial contains nominally 750 IU efmoroctocog alfa.
Icelandic: Hvert hettuglas inniheldur 750 IU af efmoroctocog alfa.
English: Swedish Orphan Biovitrum AB (publ) Strandbergsgatan 49
Icelandic: Swedish Orphan Biovitrum AB (publ) Strandbergsgatan 49 SE-112 76 Stockholm Svíþjóð
English: After reconstitution, each mL of solution for injection contains approximately 1333 IU efmoroctocog alfa.
Icelandic: Eftir blöndun inniheldur hver ml af stungulyfi, lausn u.þ.b. 1333 IU af efmoroctocog alfa.
English: After reconstitution, each mL of solution for injection contains approximately 250 IU efmoroctocog alfa.
Icelandic: Eftir blöndun inniheldur hver ml af stungulyfi, lausn u.þ.b. 250 IU af efmoroctocog alfa.
English: After reconstitution, each mL of solution for injection contains approximately 1667 IU efmoroctocog alfa.
Icelandic: Eftir blöndun inniheldur hver ml af stungulyfi, lausn u.þ.b. 1667 IU af efmoroctocog alfa.
English: ELOCTA 250 IU powder for injection ELOCTA 500 IU powder for injection ELOCTA 750 IU powder for injection ELOCTA 1000 IU powder for injection ELOCTA 1500 IU powder for injection ELOCTA 2000 IU powder for injection ELOCTA 3000 IU powder for injection ELOCTA 4000 IU powder for injection ELOCTA 5000 IU powder for injection ELOCTA 6000 IU powder for injection efmoroctocog alfa recombinant coagulation factor VIII IV
Icelandic: ELOCTA 250 IU stungulyfsstofn ELOCTA 500 IU stungulyfsstofn ELOCTA 750 IU stungulyfsstofn ELOCTA 1000 IU stungulyfsstofn ELOCTA 1500 IU stungulyfsstofn ELOCTA 2000 IU stungulyfsstofn ELOCTA 3000 IU stungulyfsstofn ELOCTA 4000 IU stungulyfsstofn ELOCTA 5000 IU stungulyfsstofn ELOCTA 6000 IU stungulyfsstofn efmoroctocog alfa raðbrigða storkuþáttur VIII i.v.
English: After reconstitution, each mL of solution for injection contains approximately 667 IU efmoroctocog alfa.
Icelandic: Eftir blöndun inniheldur hver ml af stungulyfi, lausn u.þ.b. 667 IU af efmoroctocog alfa.
English: Record on the carton the date that ELOCTA is removed from the refrigerator and set at room temperature.
Icelandic: á öskjuna þegar ELOCTA er tekið úr kæli og látið standa við stofuhita.
English: Solvent: water for injections
Icelandic: Vatn fyrir stungulyf
English: After reconstitution, each mL of solution for injection contains approximately 333 IU efmoroctocog alfa.
Icelandic: Eftir blöndun inniheldur hver ml af stungulyfi, lausn u.þ.b. 333 IU af efmoroctocog alfa.
English: ELOCTA 750 IU powder and solvent for solution for injection ELOCTA 1000 IU powder and solvent for solution for injection ELOCTA 1500 IU powder and solvent for solution for injection ELOCTA 2000 IU powder and solvent for solution for injection ELOCTA 3000 IU powder and solvent for solution for injection ELOCTA 4000 IU powder and solvent for solution for injection ELOCTA 5000 IU powder and solvent for solution for injection ELOCTA 6000 IU powder and solvent for solution for injection efmoroctocog alfa (recombinant coagulation factor VIII)
Icelandic: ELOCTA 750 IU stungulyfsstofn og leysir, lausn ELOCTA 1000 IU stungulyfsstofn og leysir, lausn ELOCTA 1500 IU stungulyfsstofn og leysir, lausn ELOCTA 2000 IU stungulyfsstofn og leysir, lausn ELOCTA 3000 IU stungulyfsstofn og leysir, lausn ELOCTA 4000 IU stungulyfsstofn og leysir, lausn ELOCTA 5000 IU stungulyfsstofn og leysir, lausn ELOCTA 6000 IU stungulyfsstofn og leysir, lausn efmoroctocog alfa (raðbrigða storkuþáttur VIII)
English: Discard the vial and the adapter.
Icelandic: - Geymið fylgiseðilinn.
English: The vial of lyophilised product powder for injection must be reconstituted with the supplied solvent (water for injections) from the pre-filled syringe using the sterile vial adapter for reconstitution.
Icelandic: Blanda verður frostþurrkaða stungulyfsstofninum í hettuglasinu við meðfylgjandi leysi (vatn fyrir stungulyf) úr áfylltri sprautu og nota skal til þess sæft millistykki til blöndunar fyrir hettuglas.
English: After reconstitution, each mL of solution for injection contains approximately 2000 IU efmoroctocog alfa.
Icelandic: Eftir blöndun inniheldur hver ml af stungulyfi, lausn u.þ.b. 2000 IU af efmoroctocog alfa.
English: ELOCTA 6000 IU powder and solvent for solution for injection Each vial contains nominally 6000 IU efmoroctocog alfa.
Icelandic: Hvert hettuglas inniheldur 6000 IU af efmoroctocog alfa.
English: Powder
Icelandic: Útbrot
English: After reconstitution, each mL of solution for injection contains approximately 500 IU efmoroctocog alfa.
Icelandic: Eftir blöndun inniheldur hver ml af stungulyfi, lausn u.þ.b. 500 IU af efmoroctocog alfa.
English: After reconstitution, each mL of solution for injection contains approximately 1000 IU efmoroctocog alfa.
Icelandic: Eftir blöndun inniheldur hver ml af stungulyfi, lausn u.þ.b. 1000 IU af efmoroctocog alfa.
English: 1 Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs= previously treated patients, PUPs= previously untreated patients.
Icelandic: Tíðni er byggð á rannsóknum með öllum lyfjum með storkuþætti VIII sem tóku til sjúklinga með alvarlega dreyrasýki A
English: Protect the prepared solution from direct sunlight.
Icelandic: Verjið blandaða lausn gegn beinu sólarljósi.
English: Sucrose
Icelandic: ELOCTA
English: The solution should appear clear to slightly opalescent and colourless.
Icelandic: Lausnin á að vera tær eða örlítið ópallýsandi og litlaus.
English: You should always use ELOCTA exactly as your doctor has told you, check with your doctor, pharmacist or nurse if you are not sure.
Icelandic: Alltaf skal nota ELOCTA nákvæmlega eins og læknirinn hefur mælt fyrir um.
English: EXPIRY DATE
Icelandic: Skrá skal dagsetninguna
English: Paediatric population No age-specific differences in adverse reactions were observed between paediatric and adult subjects.
Icelandic: Börn Ekki hefur orðið vart við neinn aldurstengdan mun á aukaverkunum hjá börnum og fullorðnum.
English: After reconstitution, each mL of solution for injection contains approximately 167 IU efmoroctocog alfa.
Icelandic: Eftir blöndun inniheldur hver ml af stungulyfi, lausn u.þ.b. 167 IU af efmoroctocog alfa.
English: ELOCTA 1500 IU powder and solvent for solution for injection Each vial contains nominally 1500 IU efmoroctocog alfa.
Icelandic: Hvert hettuglas inniheldur 1500 IU af efmoroctocog alfa.
English: Detach the syringe from the vial adapter by gently pulling and turning the vial counterclockwise.
Icelandic: 15. Losið sprautuna af millistykkinu fyrir hettuglasið með því að toga varlega og snúa hettuglasinu rangsælis.
English: Press down firmly until the adapter snaps into place on top of the vial, with the adapter spike penetrating the vial stopper.
Icelandic: Þrýstið þétt niður þar til millistykkið smellur á sinn stað ofan á hettuglasinu, þannig að oddurinn á millistykkinu fari inn í tappann á hettuglasinu.
English: Minor surgery including tooth extraction
Icelandic: Skurðaðgerð Minni háttar skurðaðgerð þ.m.t. tanndráttur
English: ELOCTA 250 IU powder and solvent for solution for injection ELOCTA 500 IU powder and solvent for solution for injection ELOCTA 750 IU powder and solvent for solution for injection ELOCTA 1000 IU powder and solvent for solution for injection ELOCTA 1500 IU powder and solvent for solution for injection ELOCTA 2000 IU powder and solvent for solution for injection ELOCTA 3000 IU powder and solvent for solution for injection ELOCTA 4000 IU powder and solvent for solution for injection ELOCTA 5000 IU powder and solvent for solution for injection ELOCTA 6000 IU powder and solvent for solution for injection efmoroctocog alfa recombinant coagulation factor VIII, Fc fusion protein
Icelandic: ELOCTA 250 IU stungulyfsstofn og leysir, lausn ELOCTA 500 IU stungulyfsstofn og leysir, lausn ELOCTA 750 IU stungulyfsstofn og leysir, lausn ELOCTA 1000 IU stungulyfsstofn og leysir, lausn ELOCTA 1500 IU stungulyfsstofn og leysir, lausn ELOCTA 2000 IU stungulyfsstofn og leysir, lausn ELOCTA 3000 IU stungulyfsstofn og leysir, lausn ELOCTA 4000 IU stungulyfsstofn og leysir, lausn ELOCTA 5000 IU stungulyfsstofn og leysir, lausn ELOCTA 6000 IU stungulyfsstofn og leysir, lausn efmoroctocog alfa raðbrigða storkuþáttur VIII, Fc samrunaprótín
English: ELOCTA 4000 IU powder and solvent for solution for injection Each vial contains nominally 4000 IU efmoroctocog alfa.
Icelandic: Hvert hettuglas inniheldur 4000 IU af efmoroctocog alfa.
English: ELOCTA 250 IU powder and solvent for solution for injection ELOCTA 500 IU powder and solvent for solution for injection ELOCTA 750 IU powder and solvent for solution for injection ELOCTA 1000 IU powder and solvent for solution for injection ELOCTA 1500 IU powder and solvent for solution for injection ELOCTA 2000 IU powder and solvent for solution for injection ELOCTA 3000 IU powder and solvent for solution for injection ELOCTA 4000 IU powder and solvent for solution for injection ELOCTA 5000 IU powder and solvent for solution for injection ELOCTA 6000 IU powder and solvent for solution for injection
Icelandic: ELOCTA 250 IU stungulyfsstofn og leysir, lausn ELOCTA 500 IU stungulyfsstofn og leysir, lausn ELOCTA 750 IU stungulyfsstofn og leysir, lausn ELOCTA 1000 IU stungulyfsstofn og leysir, lausn ELOCTA 1500 IU stungulyfsstofn og leysir, lausn ELOCTA 2000 IU stungulyfsstofn og leysir, lausn ELOCTA 3000 IU stungulyfsstofn og leysir, lausn ELOCTA 4000 IU stungulyfsstofn og leysir, lausn ELOCTA 5000 IU stungulyfsstofn og leysir, lausn ELOCTA 6000 IU stungulyfsstofn og leysir, lausn
English: Repeat injection every 12 to 24 hours for at least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.
Icelandic: 1 dag þar til blæðing hefur stöðvast eftir verkjum að dæma eða sár hafa gróið.
English: ELOCTA 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU efmoroctocog alfa.
Icelandic: Hvert hettuglas inniheldur 250 IU af efmoroctocog alfa.
English: The pharmacokinetic parameters from the chromogenic assay data were similar to those derived for the one-stage assay.
Icelandic: Lyfjahvarfabreytur úr upplýsingum úr litmyndunarprófinu voru svipaðar og fram kom með einfalda prófinu.
English: ELOCTA 5000 ELOCTA 6000
Icelandic: ELOCTA 5000 IU stungulyfsstofn og leysir, lausn
English: ELOCTA can be used for all age groups.
Icelandic: ELOCTA má nota handa öllum aldurshópum.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON
Icelandic: Fylgikvillar í tengslum við hollegg
English: The prepared solution will be clear to slightly opalescent and colourless.
Icelandic: Blandaða lausnin er tær eða örlítið ópallýsandi og litlaus.
English: ELOCTA 3000 IU powder and solvent for solution for injection Each vial contains nominally 3000 IU efmoroctocog alfa.
Icelandic: Hvert hettuglas inniheldur 3000 IU af efmoroctocog alfa.
English: Do not remove the adapter from its protective cap. Do not touch the inside of the vial adapter package.
Icelandic: Snertið ekki innri hluta pakkningarinnar með millistykkinu fyrir hettuglasið.
English: ELOCTA 5000 IU powder and solvent for solution for injection Each vial contains nominally 5000 IU efmoroctocog alfa.
Icelandic: Hvert hettuglas inniheldur 5000 IU af efmoroctocog alfa.
English: Nervous system disorders
Icelandic: Liðverkir Vöðvaverkir
English: Dosing of up to 80 IU/kg and a dosing interval as short as 2 days was allowed and used in a limited number of patients.
Icelandic: 2 dögum sem notað var af takmörkuðum fjölda sjúklinga.
English: The reconstituted solution should be clear to slightly opalescent and colourless.
Icelandic: Blandaða lausnin á að vera tær eða örlítið ópallýsandi og litlaus.
English: The final solution must be inspected visually before administration.
Icelandic: Skoða skal endanlegt útlit lausnarinnar fyrir gjöf.
English: Abdominal pain, lower Uncommon
Icelandic: Verkur í neðri hluta kviðar Sjaldgæfar
English: Weekly prophylaxis: Median annual factor consumption was 3805 IU/kg (min 3353, max 6196) in Study I and 3510 IU/kg (min 2758, max 3984) in Study III.
Icelandic: Miðgildi árlegrar notkunar storkuþáttar var 3.805 IU/kg (að lágmarki 3.353, að hámarki 6.196) í rannsókn
English: Cardiovascular events
Icelandic: Kuldatilfinning
English: Method of administration ELOCTA is for intravenous use.
Icelandic: Lyfjagjöf ELOCTA er til notkunar í bláæð.
English: ELOCTA 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU efmoroctocog alfa.
Icelandic: Hvert hettuglas inniheldur 1000 IUaf efmoroctocog alfa.
English: ELOCTA 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU efmoroctocog alfa.
Icelandic: Hvert hettuglas inniheldur 500 IU af efmoroctocog alfa.
English: ELOCTA 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU efmoroctocog alfa.
Icelandic: Hvert hettuglas inniheldur 2000 IU af efmoroctocog alfa.
English: The frequencies in Table 2 below were observed in a total of 276 patients with severe haemophilia A in phase III clinical studies and an extension study with a duration of up to four years.
Icelandic: stigs klínískum rannsóknum og framlengdri rannsókn sem stóð í allt að fjögur ár hjá samtals 276 sjúklingum með alvarlega dreyrasýki A.
English: Pharmacotherapeutic group: antihaemorrhagics, blood coagulation factor VIII, ATC code: B02BD02
Icelandic: Flokkun eftir verkun: blæðingarlyf, storkuþáttur VIII, ATC-flokkur:
English: MA (EU) number (Invented) name
Icelandic: EU/1/06/338/002 DuoTrav 40 µg/ml / 5 g/ml
English: Località Marino del Tronto 63100 Ascoli Piceno (AP) ITALY
Icelandic: Località Marino del Tronto 63100 Ascoli Piceno (AP) ÍTALÍA
English: The reason for this longer half-life is unknown.
Icelandic: Ekki er vitað um orsakir þessa lengri helmingunartíma.
English: Dogs aged 12 months or more.
Icelandic: Hundar, 12 mánaða og eldri.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/08/084/001-005
Icelandic: MARKAÐSLEYFISNÚMER EU/2/08/084/001-005
English: In rare cases these adverse reactions may be fatal.
Icelandic: Í mjög sjaldgæfum tilvikum geta þessar aukaverkanir verið banvænar.
English: Do not eat, drink, or smoke when handling the product.
Icelandic: Neytið hvorki matar né drykkjar og reykið ekki þegar lyfið er meðhöndlað.
English: ATCvet code: QM01AH92.
Icelandic: QM01AH92
English: 95 mg For the full list of excipients, see section 6.1.
Icelandic: 95 mg Sjá lista yfir öll hjálparefni í kafla 6.1.
English: Adverse reactions could occur at any time point during this period.
Icelandic: Aukaverkanir geta komið fram hvenær sem er á þessu tímabili.
English: Mavacoxib is 4-[5-(4-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]-benzenesulfonamide.
Icelandic: Mavakoxíb er 4-[5-(4-flúorófenýl)-3(þríflúorómetýl)-1H-pýrazól-1-ýl]-benzensúlfónamíð.
English: Advice for dog owner
Icelandic: Ráðleggingar fyrir hundaeigandann
English: Care should be taken to ensure that the tablet is ingested.
Icelandic: Þess skal vandlega gætt að taflan sé tekin inn.
English: A treatment cycle should not exceed 7 consecutive doses (6.5 months).
Icelandic: Meðferðarlota ætti ekki að ná yfir meira en 7 samfellda skammta (6,5 mánuði).
English: Tell your veterinarian if your dog is using a blood-thinning agent.
Icelandic: Láttu dýralækninn vita ef hundurinn þinn notar blóðþynnandi lyf.
English: Steady state pharmacokinetics was attained by the fourth treatment in most animals.
Icelandic: Lyfjahvörf voru í jafnvægi við fjórðu meðferð hjá flestum sjúklingum.
English: If your dog needs surgery, inform the surgeon that the dog is using Trocoxil.
Icelandic: Ef hundurinn þinn þarfnast skurðaðgerðar skaltu upplýsa skurðlækninn um það að hundurinn noti Trocoxil.
English: Mavacoxib is approximately 98% bound to plasma proteins.
Icelandic: Mavakoxíb er um 98% bundið plasmapróteinum.
English: These IC concentrations may be compared with mean trough concentrations of mavacoxib in plasma in clinical subjects of 0.52 and 1.11 µg/mL, respectively, after the first and fifth doses.
Icelandic: Þessa IC-þéttni má bera saman við meðal lágmarksþéttni mavakoxíbs í plasma hjá klínískum viðföngum sem er 0,52 og 1,11 míkróg/ml, hvort um sig, eftir fyrsta og fimmta skammt.
English: PACKAGE SIZE 2 tablets
Icelandic: PAKKNINGASTÆRÐ 2 töflur
English: Wash hands after handling the product.
Icelandic: Þvoið hendur eftir að hafa meðhöndlað lyfið.
English: Mavacoxib is well absorbed after oral administration; bioavailability was 87% in fed dogs and 46 % in fasted conditions and the recommended dose is based on administration with food.
Icelandic: Mavakoxíb frásogast vel eftir inntöku; aðgengi var 87% hjá fóðruðum hundum og 46% við föstu og byggist ráðlagður skammtur á gjöf með mat.
English: Based on the results of canine whole blood assays, plasma concentrations producing 20% COX-1 inhibition and 80% COX-2 inhibition were 2.46 µg/mL and 1.28 µg/mL, respectively, so that the IC20COX-1:IC80COX-2 potency ratio is approximately 2:1, whilst the IC80COX-1:IC80COX-2 potency ratio is approximately 40:1.
Icelandic: Á grundvelli niðurstaðna úr heilblóðsgreiningum á hundum nam plasmaþéttni sem olli 20% COX-1 hömlun 2,46 míkróg/ml og 80% COX-2 hömlun 1,28 míkróg/ml, þannig að virknihlutfall IC20COX1:IC80COX-2 er um 2:1, en virknihlutfall IC80COX-1:IC80COX-2 er um 40:1.
English: Do not use in dogs less than 12 months of age and/or less than 5 kg body weight.
Icelandic: Notið ekki hjá hundum undir 12 mánaða aldri og/eða léttari en 5 kg.
English: A treatment cycle with Trocoxil should not exceed 7 consecutive doses (6.5 months).
Icelandic: Meðferðarlota með Trocoxil á ekki að fara yfir 7 samfellda skammta (6,5 mánuði).
English: There are two isoforms of COX, COX-1, and COX-2.
Icelandic: Til eru tvö afbrigði (ísóform) COX, þ.e. COX-1 og COX-2.
English: Do not use concomitantly with glucocorticoids or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), see section 4.8.
Icelandic: Notið ekki samhliða sykursterum eða öðrum bólgueyðandi gigtarlyfjum (NSAIDs) sjá kafla 4.8.
English: Population pharmacokinetic data derived from studies in dogs with a predominantly older population with heavier dogs as compared to the experimental studies (mean 9 years of age) showed that the mean elimination half-life was 39 days with a small sub-population (<5%) having an elimination half-life of more than 80 days and correspondingly an increased exposure was recorded in these individuals.
Icelandic: Lyfjahvarfaupplýsingar um sjúklingahópa sem voru fengnar úr rannsóknum þar sem sjúklingahópurinn var í eldri kantinum (að meðaltali 9 ára) sýndu að meðalhelmingunartími brotthvarfs var 39 dagar, en hjá litlum undirhópi (<5%) var hann yfir 80 dagar og í samræmi við það sást aukin útsetning hjá þessum einstaklingum.
English: Mavacoxib exhibits an extended plasma half life (up to > 80 days, see section 5.2) due to its low rate of elimination.
Icelandic: Mavakoxíb hefur langan helmingunartíma í plasma (allt að > 80 daga, sjá kafla 5.2) vegna þess hversu hægt brotthvarf er.
English: Dogs should be carefully monitored if Trocoxil is administered simultaneously with an anticoagulant.
Icelandic: Fylgjast á vel með hundum ef Trocoxil er gefið samtímis segavarnarlyfi.
English: No drug interaction studies have been performed.
Icelandic: Ekki hafa verið gerðar neinar rannsóknir á milliverkunum.
English: Triangular tablet with mottled brown appearance embossed with the tablet strength on one side, the reverse side is blank.
Icelandic: Þríhyrningslaga, brúnflekkótt tafla upphleypt með styrk lyfs á annarri hliðinni, hin hliðin er auð.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and blister after Exp.
Icelandic: Ekki skal nota dýralyfið eftir fyrningardagsetningu sem tilgreind er á öskjunni og þynnu eftir EXP.
English: A maximum treatment administration of 6.5 months continuous therapy is recommended so as to manage plasma levels of mavacoxib in animals which exhibit reduced elimination
Icelandic: Mælt er með að hámarkslyfjagjöf sé 6,5 mánuðir af samfelldri meðferð ásamt því að stjórna plasmaþéttni mavakoxíb í dýrum sem sýna minnkað brotthvarf.
English: Veterinarians should be aware that clinical signs of adverse reactions may continue when supportive therapy (such as gastro protectants) is discontinued.
Icelandic: Dýralæknar eru varaðir við að klínísk einkenni um aukaverkanir geta komið fram aftur þegar stuðningsmeðferð (s.s. efni sem vernda magaslímhúð) hefur verið stöðvuð.
English: Tablets also contain the following ingredients
Icelandic: Í töflunum eru einnig eftirfarandi innihaldsefni:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 09/09/2008
Icelandic: Dagsetning fyrstu útgáfu markaðsleyfis: 09/09/2008.
English: Use the dose prescribed by the veterinarian.
Icelandic: Notið skammtinn sem dýralæknirinn ávísar.
English: The dose is 2 mg mavacoxib per kg body weight given immediately before or with the dog's main meal.
Icelandic: Skammturinn er 2 mg af mavakoxíbi á hvert kg líkamsþyngdar gefinn rétt fyrir eða með aðalmáltíð hundsins.