FrancophonIA/ELRC3.0 huggingface dataset:
English: • Do not mix Refixia with any other intravenous infusions or medications.
Icelandic: Refixia við aðra innrennslisvökva eða lyf.
English: In repeat dose toxicity studies in rats and monkeys, 40 kDa polyethylene-glycol (PEG) was detected by immunohistochemical staining in epithelial cells of choroid plexus in the brain.
Icelandic: á eiturverkunum við endurtekna skammta hjá rottum og öpum fannst 40 kDa pólýethýlenglýkól (PEG) þegar þekjufrumur æðahimnuflækju (choroid plexus) í heila voru litaðar á ónæmisvefjaefnafræðilegan hátt.
English: The use of low purity factor IX products has been associated with instances of myocardial infarction, disseminated intravascular coagulation, venous thrombosis and pulmonary embolism.
Icelandic: IX með litlum hreinleika hefur verið tengd við tilvik hjartadreps, dreifðrar blóðstorknunar, segamyndunar í bláæðum og lungnablóðrek.
English: Nephrotic syndrome has been reported following attempted immune tolerance induction in haemophilia B patients with factor IX inhibitors and a history of allergic reaction.
Icelandic: Skýrt hefur verið frá nýrungaheilkenni eftir að reynt hefur verið að framkalla ónæmisþol hjá sjúklingum með dreyrasýki B með mótefni gegn storkuþætti IX og sögu um ofnæmisviðbrögð.
English: From a microbiological point of view, the reconstituted product should be used immediately.
Icelandic: Út frá örverufræðilegu sjónarmiði á að nota blandaða lyfið strax.
English: The rate of administration should be determined by the patient's comfort level up to a maximum injection rate of 4 ml/min.
Icelandic: Hraða inndælingar ber að ákveða í samræmi við hvernig sjúklingur þolir lyfið, þó skal ekki dæla hraðar en 4 ml/mínútu.
English: • The ingredients in the sterilised solvent are histidine, water for injections, sodium hydroxide and hydrochloric acid.
Icelandic: Innihaldsefni í sæfða leysinum eru histidín, vatn fyrir stungulyf, natríumhýdroxíð og saltsýra.
English: Use of a reference laboratory is recommended when a chromogenic assay or a qualified one-stage clotting assay is not available locally.
Icelandic: Mælt er með að nota tilvísunarrannsóknarstofu þegar ekki er hægt að framkvæma litmyndunarpróf eða viðurkennt einsstigs storkupróf á staðnum.
English: • The active substance is nonacog beta pegol (pegylated human coagulation factor IX (rDNA)).
Icelandic: Virka innihaldsefnið er nonacog beta pegol (pegýleraður manna storkuþáttur IX (rDNA)).
English: Refixia may be taken out of the refrigerator for a maximum period of 6 months and stored at room temperature (up to 30°C).
Icelandic: Taka má Refixia úr kæli í að hámarki 6 mánuði og geyma við stofuhita (allt að 30°C).
English: Please record on the carton the date Refixia is removed from the refrigerator and placed at room temperature.
Icelandic: Skráið dagsetninguna sem Refixia er tekið úr kæli og sett í geymslu við stofuhita á öskjuna.
English: Adjustments of doses and administration intervals may be considered based on achieved FIX levels and individual bleeding tendency.
Icelandic: Íhuga má aðlögun skammta og skömmtunartíma út frá þeim gildum FIX sem nást og blæðingartilhneigingu hvers einstaklings.
English: 18-65 years
Icelandic: 18-65 ára N=20
English: • Do not touch the syringe tip under the syringe cap.
Icelandic: Ekki koma við sprautuoddinn undir sprautuhettunni.
English: Refixia is to be administered intravenously after reconstitution of the powder with the solvent supplied in the syringe.
Icelandic: Refixia á að gefa í bláæð eftir að stofninn hefur verið blandaður með leysinum sem er í meðfylgjandi sprautu.
English: If it cannot be used immediately, use within 24 hours if stored in a refrigerator at 2°C - 8°C or within 4 hours if stored out of the refrigerator at a maximum temperature of 30°C.
Icelandic: ef það er geymt í kæli við 2°C - 8°C, eða innan 4 klst.
English: Activated factor IX, in combination with activated factor VIII, activates factor X. Activated factor X converts prothrombin into thrombin.
Icelandic: Virkjaður storkuþáttur X breytir síðan prótrombíni í trombín.
English: INFORMATION IN BRAILLE Refixia 1000 IU
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI Refixia 1000 a.e.
English: Pack contains: 1 powder vial, 4 ml solvent in a pre-filled syringe, 1 plunger rod and 1 vial adapter
Icelandic: 1 hettuglas með stofni, 4 ml af leysi í áfylltri sprautu, 1 stimpilstöng og 1 millistykki fyrir hettuglas
English: Table 6 Mean of trough levels* of Refixia (40 IU/kg) at steady state
Icelandic: Tafla 6 Meðal lágstyrkur* Refixia (40 a.e/kg) við jafnvægi
English: INFORMATION IN BRAILLE Refixia 500 IU
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI Refixia 500 a.e.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1000 IU
Icelandic: INNIHALD TILGREINT SEM ÞYNGD, RÚMMÁL EÐA FJÖLDI EININGA 1000 a.e.
English: STATEMENT OF ACTIVE SUBSTANCE Powder: 500 IU nonacog beta pegol (approx. 125 IU/ml after reconstitution),
Icelandic: 500 a.e. nonacog beta pegol (u.þ.b. 125 a.e./ml eftir blöndun),
English: • If the CVAD line needs to be flushed before or after Refixia injection, use sodium chloride 9 mg/ml solution for injection.
Icelandic: Ef skola þarf CVAD slönguna fyrir eða eftir lyfjagjöf með Refixia á að nota natríumklóríð
English: The dose recommendations in adolescents (12-18 years) are the same as for adults: 40 IU/kg body weight.
Icelandic: Ráðlagðir skammtar fyrir unglinga (12-18 ára) eru þeir sömu og fyrir fullorðna:
English: Allergic type hypersensitivity reactions are possible with Refixia.
Icelandic: Hugsanlegt er að ofnæmisviðbrögð komi fram við notkun Refixia.
English: After reconstitution, 1 ml of Refixia contains approximately 250 IU nonacog beta pegol.
Icelandic: Eftir blöndun inniheldur 1 ml af Refixia um það bil 250 a.e. af nonacog beta pegol.
English: • Remove the protective paper from the vial adapter.
Icelandic: Fjarlægðu hlífðarpappírinn af millistykkinu.
English: After injection, safely dispose of the syringe with the infusion set and the vial with the vial adapter.
Icelandic: Fargið sprautunni ásamt inndælingarbúnaði og hettuglasinu með millistykkinu á öruggan hátt eftir inndælingu.
English: • Take the vial, the vial adapter and the prefilled syringe out of the carton.
Icelandic: Taktu hettuglasið, millistykkið fyrir hettuglasið og áfylltu sprautuna úr öskjunni.
English: • you have recently had surgery
Icelandic: ef þú hefur farið í aðgerð nýlega
English: Volume of distribution (Vss) (ml/kg) Factor IX activity 168 h post dosing (IU/ml)
Icelandic: Úthreinsun (CL) (ml/klst./kg) Meðaldvalartími (MRT) (klukkustundir) 144 (15) Dreifingarúmmál (Vss) (ml/kg) Virkni storkuþáttar IX 168 klst. eftir gjöf (a.e./ml)
English: Very rarely development of antibodies to hamster protein with related hypersensitivity reactions has been observed.
Icelandic: Örsjaldan hefur myndast mótefni gegn hamstrapróteinum og ofnæmisviðbrögð því tengdu komið fram.
English: Refixia contains the active substance nonacog beta pegol and is a long-acting recombinant coagulation factor IX product.
Icelandic: Refixia inniheldur virka efnið nonacog beta pegol og er lyf með raðbrigða storkuþætti IX með langvarandi verkun.
English: • hot flush.
Icelandic: • hitakóf.
English: During the shelf life Refixia may be stored up to 30°C for a single period not exceeding 6 months.
Icelandic: 2 ár. Á endingartíma lyfsins má geyma Refixia við hita allt að 30°C í eitt 6 mánaða tímabil.
English: The listed warnings and precautions apply both to adults and adolescents (12-18 years).
Icelandic: Refixia er ekki ætlað til notkunar handa börnum (yngri en 12 ára) Varnaðarorð og varúðarreglur eiga við um fullorðna og unglinga (12-18 ára).
English: If the medicine has not been used before the new expiry date, it should be disposed of.
Icelandic: Farga skal lyfinu ef það hefur ekki verið notað áður en nýja fyrningardagsetningin rennur upp.
English: Allergic reactions are possible with this medicine.
Icelandic: Hugsanlega koma fram ofnæmisviðbrögð við þessu lyfi.
English: Incremental Recovery (IR) (IU/ml per IU/kg)
Icelandic: Stigvaxandi heimtur (IR) (a.e./ml á a.e./kg)
English: After reconstitution, 1 ml of Refixia contains approximately 500 IU nonacog beta pegol.
Icelandic: Eftir blöndun inniheldur 1 ml af Refixia um það bil 500 a.e. af nonacog beta pegol.
English: Degree of haemorrhage
Icelandic: Tegund skurðaðgerðar
English: • After injection, safely dispose of all unused Refixia solution, the syringe with the infusion set, the vial with the vial adapter and other waste materials as instructed by your pharmacist.
Icelandic: Refixia lausn, sprautunni ásamt innrennslisbúnaði, hettuglasinu ásamt millistykkinu og öðrum úrgangi eins og lyfjafræðingurinn segir til um.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Solvent for Refixia
Icelandic: HEITI LYFS OG ÍKOMULEIÐ Leysir fyrir Refixia Histidínlausn
English: No difference in the safety profile of Refixia was observed between previously treated adolescent (12-18 years) and adult patients.
Icelandic: Refixia þegar borin voru saman unglingar (12-18 ára) og fullorðnir sjúklingar sem höfðu áður fengið meðferð.
English: For modified long-acting factor products it is known that the one-stage clotting assay results are highly dependent on the aPTT reagent and reference standard used.
Icelandic: Vitað er að niðurstöður einsstigs storkuprófs eru mjög háðar aPTT-hvarfmiðlinum og þeim viðmiðunarstaðli sem notaður er, þegar um er að ræða lyf sem innihalda breytta langverkandi storkuþætti.
English: In case of residual FIX activity levels, there is a risk of interference when performing the Nijmegen modified Bethesda assay for inhibitor testing.
Icelandic: Hætta er á truflun þegar Nijmegen aðlagað Bethesda-próf fyrir mótefnahömlun er framkvæmt ef eftirstandandi virkni FIX er til staðar.
English: The use of Refixia in children below 12 years is not indicated.
Icelandic: Refixia hjá börnum yngri en 12 ára.
English: Chemical and physical in-use stability have been demonstrated for 24 hours stored in a refrigerator
Icelandic: Eftir blöndun hefur verið sýnt fram á efna- og eðlisfræðilegan stöðugleika í 24 klst. í kæli
English: When you bleed, Refixia is activated in the blood to form factor IX.
Icelandic: Refixia í blóðinu og fer að mynda storkuþátt IX.
English: No mechanism behind the tremors was identified.
Icelandic: Ekki hefur verið greint frá einkennum vegna ofskömmtunar.
English: Area under the curve (AUC)0-168h (IU*hours/ml)
Icelandic: Stigvaxandi heimtur (IR) (a.e./ml á a.e./kg) 0,018 (28) Flatarmál undir ferli (AUC)0-168 klst.
English: Depending on the location and the severity of bleeding you may need a higher dose (80 IU per kg) or extra injections.
Icelandic: Þú gætir þurft stærri skammt (80 a.e. á kg) eða aukasprautur eftir því hvar blæðingin er staðsett og hversu alvarleg hún er.
English: Factor IX is a single chain glycoprotein.
Icelandic: Storkuþáttur IX er stök sykurpróteinkeðja.
English: Nausea
Icelandic: Kvarði
English: Cardiovascular event
Icelandic: Hjartsláttarónot
English: Refixia is not indicated for use in children (below 12 years).
Icelandic: Refixia er ekki ætlað til notkunar hjá börnum yngri en 12 ára.
English: • feeling sick (nausea)
Icelandic: Nýrnasjúkdómur (nýrungaheilkenni)
English: Clinical efficacy
Icelandic: Sértæk virkni
English: Pre-operative dose.
Icelandic: AÐFERÐ VIÐ LYFJAGJÖF
English: The powder in the vial appears as a white to off-white powder.
Icelandic: Stungulyfsstofninn í hettuglasinu er hvítt eða beinhvítt duft.
English: NAME OF THE MEDICINAL PRODUCT Refixia 2000 IU powder and solvent for solution for injection nonacog beta pegol (recombinant coagulation factor IX)
Icelandic: Refixia 2000 a.e. stungulyfsstofn og leysir, lausn nonacog beta pegol (raðbrigða storkuþáttur IX)
English: NAME OF THE MEDICINAL PRODUCT Refixia 1000 IU powder and solvent for solution for injection nonacog beta pegol (recombinant coagulation factor IX)
Icelandic: Refixia 1000 a.e. stungulyfsstofn og leysir, lausn nonacog beta pegol (raðbrigða storkuþáttur IX)
English: Vial with Refixia powder
Icelandic: Hettuglas með Refixia stungulyfsstofni (duft)
English: Overall haemostatic efficacy
Icelandic: VIRKT EFNI Stungulyfsstofn:
English: NAME OF THE MEDICINAL PRODUCT Refixia 500 IU powder and solvent for solution for injection nonacog beta pegol (recombinant coagulation factor IX)
Icelandic: Refixia 500 a.e. stungulyfsstofn og leysir, lausn nonacog beta pegol (raðbrigða storkuþáttur IX)
English: Paediatric population
Icelandic: Meðaltal heildargjafar
English: Reconstituted medicinal product should be inspected visually for particulate matter and discoloration prior to administration.
Icelandic: Skoða skal blandaða lyfið sjónrænt með tilliti til agna og litabreytinga áður en það er gefið.
English: NAME OF THE MEDICINAL PRODUCT Refixia 500 IU powder and solvent for solution for injection Refixia 1000 IU powder and solvent for solution for injection Refixia 2000 IU powder and solvent for solution for injection
Icelandic: Refixia 500 a.e. stungulyfsstofn og leysir, lausn Refixia 1000 a.e. stungulyfsstofn og leysir, lausn Refixia 2000 a.e. stungulyfsstofn og leysir, lausn
English: Bleeding episodes were treated with Refixia at 40 IU/kg for mild or moderate bleeds.
Icelandic: Blæðingartilfelli sem voru væg eða miðlungs alvarleg voru meðhöndluð með Refixia í skammtinum 40 a.e./kg.
English: MARKETING AUTHORISATION NUMBERS EU/1/17/1193/001
Icelandic: MARKAÐSLEYFISNÚMER EU/1/17/1193/001
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Refixia 2000 IU powder for solution for injection nonacog beta pegol
Icelandic: HEITI LYFS OG ÍKOMULEIÐ Refixia 2000 a.e. stungulyfsstofn, lausn nonacog beta pegol i.v.
English: Recommended dose IU/kg of Refixia
Icelandic: Ráðlagður skammtur a.e./kg
English: Injecting Refixia via needleless connectors for intravenous (IV) catheters
Icelandic: Refixia með nálarlausum tengibúnaði fyrir æðalegg
English: Check with your doctor if you are not sure about how to use Refixia.
Icelandic: Leitið til læknisins ef þörf er á frekari upplýsingum um notkun lyfsins.
English: Allergic reactions and development of inhibitors There is a rare risk that you may experience a sudden and severe allergic reaction (e.g. anaphylactic reaction) to Refixia.
Icelandic: Í mjög sjaldgæfum tilvikum geta skyndileg og alvarleg ofnæmisviðbrögð (t.d. bráðaofnæmi) komið fram vegna Refixia.
English: Please record the beginning of storage at room temperature on the product carton.
Icelandic: Skrifið dagsetninguna á lyfjaöskjuna þegar byrjað er að geyma lyfið við stofuhita.
English: Refixia 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU nonacog beta pegol*.
Icelandic: Hvert hettuglas inniheldur 2000 a.e. af nonacog beta pegol*.
English: • Keep the plunger rod pushed completely in.
Icelandic: Haltu stimpilstönginni alveg inni.
English: MARKETING AUTHORISATION NUMBER EU/1/17/1193/002
Icelandic: MARKAÐSLEYFISNÚMER EU/1/17/1193/002
English: Prophylaxis
Icelandic: Hitakóf
English: • Turn over the protective cap, and snap the vial adapter onto the vial.
Icelandic: Snúðu hlífðarhettunni við og smelltu millistykkinu á hettuglasið.
English: Gastrointestinal disorders
Icelandic: Skammtaráðleggingar af Refixia
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Refixia 1000 IU powder for solution for injection nonacog beta pegol
Icelandic: HEITI LYFS OG ÍKOMULEIÐ Refixia 1000 a.e. stungulyfsstofn, lausn nonacog beta pegol i.v.
English: INSTRUCTIONS ON USE
Icelandic: Meðferð eftir þörfum
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Refixia 500 IU powder for solution for injection nonacog beta pegol
Icelandic: HEITI LYFS OG ÍKOMULEIÐ Refixia 500 a.e. stungulyfsstofn, lausn nonacog beta pegol i.v.
English: *Pruritus includes the terms pruritus and ear pruritus **Injection site reactions include injection site pain, infusion site pain, injection site swelling, injection site erythema and injection site rash.
Icelandic: *Kláði felur í sér hugtökin kláði og eyrnakláði **Viðbrögð á stungustað eru m.a. verkur á stungustað, verkur á innrennslisstað, bólga á stungustað, roði á stungustað og útbrot á stungustað.
English: Frequency
Icelandic: Gentofte
English: Palpitations
Icelandic: Plasthetta
English: Adverse reaction
Icelandic: Refixia inniheldur
English: MARKETING AUTHORISATION NUMBER EU/1/17/1193/003
Icelandic: MARKAÐSLEYFISNÚMER EU/1/17/1193/003
English: After storage at room temperature the medicine must not be put back in the refrigerator.
Icelandic: Ekki má setja lyfið í kæli aftur eftir geymslu við stofuhita.
English: The reconstituted product must be injected into your vein (intravenous (IV) injection).
Icelandic: Sprauta þarf blönduðu lyfinu í bláæð (inndæling í æð, i.v.).
English: STATEMENT OF ACTIVE SUBSTANCE Powder: 2000 IU nonacog beta pegol (approx. 500 IU/ml after reconstitution),
Icelandic: VIRKT EFNI Stungulyfsstofn: 2000 a.e. nonacog beta pegol (u.þ.b.
English: PHARMACEUTICAL FORM Powder and solvent for solution for injection.
Icelandic: Lyfið inniheldur snefil af próteinum úr hömstrum.
English: Unopened
Icelandic: Inndæling
English: Contents
Icelandic: Refixia
English: In the clinical trial programme, dose adjustment was not performed.
Icelandic: Skammtaaðlögun fór ekki fram í klínískum prófunum.
English: Syringe tip (under syringe cap) Scale
Icelandic: Sprautuoddur (undir sprautuhettunni)
English: Powder
Icelandic: • kláði
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton
Icelandic: SÉRSTAKAR VARÚÐARRÁÐSTAFANIR VIÐ FÖRGUN LYFJALEIFA
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Icelandic: Refixia og pakkningastærðir
English: • shortness of breath or wheezing
Icelandic: mæði eða hvæsandi öndun
English: Solvent
Icelandic: Verkun
English: 2000 IU powder in a vial and 4 ml solvent in a pre-filled syringe, a plunger rod with a vial adapter - pack size of 1).
Icelandic: Refixia er afgreitt sem stungulyfsstofn og leysir, lausn (500 a.e., 1000 a.e. eða 2000 a.e. af dufti í hettuglasi og 4 ml af leysi í áfylltri sprautu, stimpilstöng með millistykki fyrir hettuglas - pakkningastærð 1).
English: What you need to know before you use Refixia
Icelandic: Áður en byrjað er að nota Refixia
English: • skin reactions at the site of injection
Icelandic: húðviðbrögð á stungustað
English: On-demand treatment
Icelandic: Fyrirbyggjandi meðferð
English: • 1 vial with Refixia powder
Icelandic: 1 hettuglas með Refixia stungulyfsstofni (duft)
English: Refixia 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU nonacog beta pegol*.
Icelandic: Hvert hettuglas inniheldur 500 a.e. af nonacog beta pegol*.
English: Overview
Icelandic: Yfirlitsmynd
English: Refixia 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU nonacog beta pegol*.
Icelandic: Hvert hettuglas inniheldur 1000 a.e. af nonacog beta pegol*.
English: Catheter-related problems
Icelandic: Vandamál tengd æðaleggjum
English: Pack size of 1.
Icelandic: eftir skammt og hjaðnaði innan 1 klst.
English: Milk: 72 hours
Icelandic: 72 klukkustundir
English: Whereas:
Icelandic: Þar sem:
English: According to the current product information for Dexadreson, treatment may be repeated after 24-48 hours.
Icelandic: Samkvæmt núverandi vöruupplýsingum um Dexadreson, má endurtaka meðferðina eftir 24-48 klukkustundir.
English: Reus-Vinyols, Km 4,1 43330 Riudoms, Tarragona SPAIN
Icelandic: Reus-Vinyols, Km 4,1 43330 Riudoms, Tarragona SPÁNN
English: 192 07 Sollentuna SWEDEN
Icelandic: 192 07 Sollentuna SVÍÞJÓÐ
English: Rue Olivier De Serres Angers Technopole 49071 Beaucouze Cedex FRANCE
Icelandic: Rue Olivier De Serres Angers Technopole 49071 Beaucouze Cedex FRAKKLAND
English: Delete, where applicable, “in cases of shock in horses”.
Icelandic: Eyðið, þar sem við á, “í tilfellum losts hjá hestum”.
English: Intervet GmbH Siemensstraße 107 AT-1210 Wien AUSTRIA
Icelandic: Intervet GmbH Siemensstraße 107 AT-1210 Wien AUSTURRÍKI
English: Kidney and liver were the tissues where the marker residue persisted longest.
Icelandic: Nýru og lifur voru þeir vefir þar sem leifamerkið hélst lengst.
English: 4941 VX Raamsdonksveer THE NETHERLANDS
Icelandic: 4941 VX Raamsdonksveer HOLLAND
English: Albrecht GmbH Hauptstr.
Icelandic: Þýskaland Albrecht GmbH Hauptstr.
English: Intervet International B.V. Wim de Körverstraat 35 5831, AN Boxmeer THE NETHERLANDS
Icelandic: Intervet International B.V. Wim de Körverstraat 35 5831, AN Boxmeer HOLLAND
English: United Kingdom Intervet UK Ltd Walton Manor, Walton Milton Keynes MK7 7AJ UNITED KINGDOM
Icelandic: Intervet UK Ltd Walton Manor, Walton Milton Keynes MK7 7AJ BRETLAND
English: Rua Agualva dos Açores n.º 16 2735-557 Agualva-Cacém, PORTUGAL
Icelandic: Rua Agualva dos Açores n.º 16 2735-557 Agualva-Cacém, PORTÚGAL
English: Quality, target animals safety, user safety and environmental risk have not been assessed in this referral procedure.
Icelandic: Gæði, öryggi markdýra, notandaöryggi og umhverfishættur hafa ekki verið metnar í þessari málsskotsmeðferð.
English: All studies were conducted at a single dose of 0.06 mg/kg body weight.
Icelandic: Allar rannsóknirnar voru framkvæmdar á einföldum skammti á 0,06 mg/kg líkamsþyngdar.
English: Therefore, on 22 August 2012, Germany presented to the Agency a referral notification under Article 35 of Directive 2001/82/EC for Dexadreson 2 mg/ml and associated names, and generic products thereof.
Icelandic: Af þeim sökum kynnti Þýskaland stofnuninni hinn 22. ágúst 2012 málsskotstilkynningu samkvæmt 35. grein tilskipunar 2001/82/EB fyrir Dexadreson 2 mg/ml og tengdra nafna og samheitalyfja þeirra.
English: 5830 AB Boxmeer THE NETHERLANDS
Icelandic: 5830 AB Boxmeer HOLLAND
English: Conclusions on the benefit-risk balance
Icelandic: Niðurstöður um jafnvægið á milli ávinnings og áhættu
English: Further to this restriction the CVMP concluded that the single administration of the concerned products does not have an impact on their clinical efficacy.
Icelandic: Auk þessara takmarkana ákvarðaði CVMP að einfaldur skammtur af viðkomandi lyfi hefði ekki áhrif á klíníska verkun þeirra.
English: Delete, where applicable, all references for repeat treatment in cattle and horses and treatment in cases of shock in horses.
Icelandic: Eyðið, þar sem við á, öllum tilvísunum um endurtekna meðferð hjá nautgripum og hestum og meðferð í tilfellum losts hjá hestum.
English: Therefore it was considered appropriate to use the alternative method in order to establish a withdrawal period for cattle tissues.
Icelandic: Því var talið viðeigandi að nota hina aðferðina til þess að kveða á um biðtíma afurðanýtingar fyrir vefi nautgripa.
English: Germany noted that Dexadreson 2 mg/ml and its associated names has different withdrawal periods in cattle (meat and milk) and horses (meat) established by the Member States across the EU/EEA.
Icelandic: Þýskaland veitti athygli að Dexadreson 2 mg/ml og tengd nöfn þess hafa mismunandi biðtíma afurðanýtingar í nautgripum (kjöti og mjólk) og hrossum (kjöti) sem ákvarðað var af aðildarríkjunum í ESB/EES.
English: Three residue depletion studies in cattle have been provided, two studies on residue depletion in cattle tissues and one study on residue depletion in milk.
Icelandic: Gefnar hafa verið upp þrjár rannsóknir á eyðingu lyfjaleifa í nautgripum, tvær rannsóknir á eyðingu lyfjaleifa í vefjum nautgripa og ein rannsókn um eyðingu lyfjaleifa í mjólk.
English: Dexamethasone is a long acting synthetic glucocorticoid used as anti-inflammatory, anti-allergic and gluconeogenetic agent for administration to agricultural and domestic animals.
Icelandic: Dexametasón eru langvirkandi syntesískir sykursterar, sem notaðir eru gegn bólgum, ofnæmi og sem glukóneogenetik lyf fyrir hús- og gæludýr.
English: The marketing authorisation holders agreed to remove the advice on repeat dose treatment in horses from the product information.
Icelandic: Markaðsleyfishafarnir samþykktu að fjarlægja ráðleggingar um endurtekna skammtameðferð í hrossum úr upplýsingum lyfsins.
English: The benefit-risk balance for the products concerned remains positive subject to amendments in the product information.
Icelandic: Jafnvægið á milli ávinnings og áhættu fyrir umrædd lyf er áfram jákvætt að gefnum breytingum í upplýsingum um lyfið.