FrancophonIA/ELRC3.0 huggingface dataset:
English: Holding the syringe by the barrel, snap the syringe cap off the tip (D).
Icelandic: Haldið í belg sprautunnar og brjótið sprautuhettuna af endanum (D).
English: No cases of overdose have been reported.
Icelandic: Ekki hefur verið greint frá neinum tilvikum ofskömmtunar.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 5 mL [for reconstitution of strengths 2000/3000 IU]
Icelandic: INNIHALD TILGREINT SEM ÞYNGD, RÚMMÁL EÐA FJÖLDI EININGA 5 ml [fyrir blöndun styrkleika 2000/3000 a.e.]
English: The potency (IU) is determined using the European Pharmacopoeia chromogenic assay.
Icelandic: Virknin (a.e.) er ákvörðuð með því að nota litmyndunarpróf samkvæmt Evrópsku lyfjaskránni.
English: No interactions of human coagulation factor VIII (rDNA) products with other medicinal products have been reported.
Icelandic: Ekki hefur verið tilkynnt um milliverkanir lyfja sem innihalda storkuþátt VIII úr mönnum (rDNA) við önnur lyf.
English: The specific activity of Kovaltry is approximately 4000 IU/mg protein.
Icelandic: Eðlisvirkni Kovaltry er u.þ.b. 4.000 a.e./mg próteins.
English: • the severity of your haemophilia A
Icelandic: • alvarleika dreyrasýki A
English: Now remove and discard the adapter housing (E).
Icelandic: Fjarlægið og fargið hulstri millistykkisins (E).
English: 1 vial with powder, 1 pre-filled syringe with water for injections, 1 vial adapter and 1 venipuncture set.
Icelandic: 1 hettuglas með stungulyfsstofni, 1 áfyllt sprauta með vatni fyrir stungulyf, 1 millistykki á hettuglas og 1 sett til bláæðarástungu.
English: Do not shake vial.
Icelandic: Hristið ekki hettuglasið.
English: Kovaltry contains the active substance human recombinant coagulation factor VIII, also called octocog alfa.
Icelandic: Kovaltry inniheldur virka efnið raðbrigða storkuþátt VIII úr mönnum, einnig nefndan októkóg alfa.
English: It is recommended that every time you use Kovaltry, you note down the name and batch number of the product.
Icelandic: Mælt er með því að þú skráir heiti og lotunúmer lyfsins í hvert skipti sem þú notar Kovaltry.
English: Haemophilic patients with cardiovascular risk factors or diseases may be at the same risk to develop cardiovascular events as non-haemophilic patients when clotting has been normalised by treatment with factor VIII.
Icelandic: Dreyrasjúklingar með áhættuþætti eða sjúkdóma tengda hjarta og æðakerfi kunna að eiga sömu hættu á því að fá hjarta- og æðakvilla og sjúklingar sem ekki eru með dreyrasýki, þegar storknun hefur verið leiðrétt með storkuþætti VIII.
English: Since Kovaltry is a replacement protein of endogenous factor VIII, no adverse effects on fertility are expected.
Icelandic: Þar sem Kovaltry er prótein sem bætir upp skort á eigin storkuþætti VIII er ekki gert ráð fyrir neinum aukaverkunum á frjósemi.
English: Attach the pre filled syringe to the threaded vial adapter by turning clockwise (F).
Icelandic: Festið áfylltu sprautuna við snittaða millistykkið fyrir hettuglas með því að snúa réttsælis (F).
English: Allergic type hypersensitivity reactions are possible with Kovaltry.
Icelandic: Ofnæmi er hugsanlegt við notkun Kovaltry.
English: Calcium chloride dihydrate Polysorbate 80
Icelandic: Kalsíumklóríð tvíhýdrat Pólýsorbat 80
English: Kovaltry can be used for all age groups.
Icelandic: Kovaltry má nota fyrir alla aldurshópa.
English: 39 IU/kg (21;72 IU /kg)
Icelandic: 39 a.e./kg (21;72 a.e
English: Ask your pharmacist or physician how to throw away medicines you no longer use.
Icelandic: Leitið ráða í apóteki eða hjá lækninum um hvernig heppilegast er að farga lyfjum sem hætt er að nota.
English: Kovaltry contains sodium
Icelandic: Kovaltry inniheldur natríum
English: Post-authorisation Efficacy Study: In order to investigate the safety and efficacy of Kovaltry in previously untreated patients, the MAH should submit the results of the ongoing study “13400 - Leopold Kids Part B”
Icelandic: Kovaltry hjá sjúklingum sem ekki hafa áður fengið meðferð mun markaðsleyfishafi leggja fram niðurstöður rannsóknarinnar 13400-Leopold Kids, B-hluti, sem enn stendur yfir.
English: You will need alcohol swabs, gauze pads, plasters and tourniquet.
Icelandic: Nákvæmar leiðbeiningar um blöndun og gjöf Kovaltry Þú munt þurfa sprittþurrkur, grisjupúða, plástra og stasa.
English: The active substance is human coagulation factor VIII (octocog alfa).
Icelandic: Virka innihaldsefnið er storkuþáttur VIII úr mönnum (októkóg alfa).
English: Table 4: PK parameters (geometric mean (%CV)) based on chromogenic assay.
Icelandic: Lyfjahvarfabreytur (margfeldismeðaltal (%CV)) byggðar á litrófsgreiningu.
English: In this case, the product expires at the end of this 12 month period or the expiry date on the product vial, whichever is earlier.
Icelandic: 12 mánaða tímabils eða við fyrningardagsetningu hettuglassins með lyfinu, hvort sem fyrr verður.
English: Kovaltry 500
Icelandic: MEÐ BLINDRALETRI Kovaltry 500
English: CL (dL/h/kg) Vss (dL/kg)
Icelandic: AUC (a.e.klst./dl) ** 1.858 (38) CL (dl/klst./kg) Vss (dl/kg)
English: Kovaltry 250 IU powder and solvent for solution for injection Kovaltry 500 IU powder and solvent for solution for injection Kovaltry 1000 IU powder and solvent for solution for injection Kovaltry 2000 IU powder and solvent for solution for injection Kovaltry 3000 IU powder and solvent for solution for injection
Icelandic: Kovaltry 250 a.e. stungulyfsstofn og leysir, lausn Kovaltry 500 a.e. stungulyfsstofn og leysir, lausn Kovaltry 1000 a.e. stungulyfsstofn og leysir, lausn Kovaltry 2000 a.e. stungulyfsstofn og leysir, lausn Kovaltry 3000 a.e. stungulyfsstofn og leysir, lausn
English: For reconstitution read package leaflet before use.
Icelandic: Varðandi blöndun, lesið fylgiseðilinn fyrir notkun.
English: The new expiry date must be noted on the outer carton.
Icelandic: Nýja fyrningardagsetningu skal skrifa á öskjuna.
English: The clinical relevance of inhibitor development will depend on the titre of the inhibitor, with low titre posing less of a risk of insufficient clinical response than high titre inhibitors.
Icelandic: Klínískt mikilvægi mótefnamyndunar fer eftir títra mótefnisins, þar sem mótefni með lágan títra valda minni hættu á ófullnægjandi klínískri svörun en mótefni með háan títra.
English: INFORMATION IN BRAILLE Kovaltry 250
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI Kovaltry 250
English: The reconstituted product must be filtered by using the vial adapter before administration to remove any possible particles in the solution.
Icelandic: Blandaða lausn á að sía með því að nota millistykkið fyrir hettuglasið fyrir gjöf til að fjarlægja hugsanlegar agnir úr lausninni.
English: Check with your doctor or pharmacist if you are not sure.
Icelandic: Leitið ráða hjá lækninum eða lyfjafræðingi ef:
English: * Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously-untreated patients ** includes injection site extravasation, hematoma, infusion site pain, pruritus, swelling *** rash, rash erythematous, rash pruritic
Icelandic: Sjaldgæfar *Tíðni er byggð á rannsóknum með öllum lyfjum með storkuþætti VIII sem tóku til sjúklinga með alvarlega dreyrasýki A. ** þ.m.t. utanæðablæðing á stungustað, margúll, verkur á innrennslisstað, kláði, þroti *** útbrot, útbrot með roða, útbrot með kláða
English: During the course of treatment, appropriate determination of factor VIII levels is advised to guide the dose to be administered and the frequency of repeated infusions.
Icelandic: Meðan á meðferð stendur er ráðlagt að ákvarða þéttni storkuþáttar VIII með viðeigandi hætti til aðstoðar við ákvörðun skammta og tíðni endurtekins innrennslis.
English: Warnings and precautions Talk to your doctor or pharmacist if you have: tightness in the chest, dizziness (including when you get up from sitting or lying down), itchy nettle-rash, wheezing, feeling sick or faint.
Icelandic: þú finnur fyrir þyngslum fyrir brjósti, svima (þ.m.t. þegar þú stendur upp eftir að hafa setið eða legið), útbrotum með kláða, mási, ógleði eða máttleysistilfinningu.
English: Set the syringe aside for further use.
Icelandic: Leggið sprautuna til hliðar til síðari notkunar.
English: Prevention of bleeding
Icelandic: Lífshættuleg blæðing
English: 3000 IU) solvent (clear glass cylinder type 1 with grey bromobutyl rubber blend stopper)
Icelandic: og 3000 a.e.) af leysi (glær glerlykja, af tegund 1 með gráum gúmmítappa úr brómbútýl).
English: How to store Kovaltry
Icelandic: Hvernig geyma á Kovaltry
English: Stop administering the product immediately and seek medical advice if this occurs.
Icelandic: Ef þetta kemur fyrir skal strax hætta gjöf lyfsins og leita ráðlegginga hjá lækni.
English: Kovaltry 250 IU powder and solvent for solution for injection Kovaltry 500 IU powder and solvent for solution for injection Kovaltry 1000 IU powder and solvent for solution for injection Kovaltry 2000 IU powder and solvent for solution for injection Kovaltry 3000 IU powder and solvent for solution for injection recombinant human coagulation factor VIII (octocog alfa)
Icelandic: Kovaltry 250 a.e. stungulyfsstofn og leysir, lausn Kovaltry 500 a.e. stungulyfsstofn og leysir, lausn Kovaltry 1000 a.e. stungulyfsstofn og leysir, lausn Kovaltry 2000 a.e. stungulyfsstofn og leysir, lausn Kovaltry 3000 a.e. stungulyfsstofn og leysir, lausn raðbrigða storkuþáttur VIII (októkóg alfa) úr mönnum
English: INFORMATION IN BRAILLE Kovaltry 2000
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI Kovaltry 2000
English: Kovaltry 1000
Icelandic: MEÐ BLINDRALETRI Kovaltry 1000
English: If you store it at room temperature it expires after 12 months or at the expiry date if this is earlier.
Icelandic: Ef lyfið er geymt við stofuhita, fyrnist það eftir 12 mánuði nema fyrningardagsetning hettuglassins sé fyrr en þá gildir hún.
English: Kovaltry 3000
Icelandic: MEÐ BLINDRALETRI Kovaltry 3000
English: B. PACKAGE LEAFLET
Icelandic: 1 stök pakkning
English: Place the powder vial on a firm, non slip surface.
Icelandic: Komið hettuglasinu með stofninum fyrir á traustu, stömu yfirborði.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Kovaltry 500 IU contains (500 IU / 2.5 mL) = 200 IU octocog alfa per mL after reconstitution.
Icelandic: VIRK(T) EFNI Kovaltry 500 a.e. inniheldur (500 a.e. / 2,5 ml) = 200 a.e. októkóg alfa á hvern ml eftir blöndun.
English: Table 1: Guide for dosing in bleeding episodes and surgery Degree of haemorrhage/
Icelandic: Leiðbeiningar um skömmtun við blæðingar og skurðaðgerðir Alvarleiki blæðingar / Tegund aðgerðar
English: Kovaltry 2000
Icelandic: MEÐ BLINDRALETRI Kovaltry 2000
English: STATEMENT OF ACTIVE SUBSTANCE(S) Kovaltry 250 IU contains (250 IU / 2.5 mL) = 100 IU octocog alfa per mL after reconstitution.
Icelandic: VIRK(T) EFNI Kovaltry 250 a.e. inniheldur (250 a.e. / 2,5 ml) = 100 a.e. októkóg alfa á hvern ml eftir blöndun.
English: FVIII inhibition very common (PUPs)* uncommon (PTPs)*
Icelandic: Mjög algengar (sjúklingar sem ekki hafa fengið meðferð áður)* Sjaldgæfar (sjúklingar sem hafa fengið meðferð áður)*
English: Pack sizes 1 single pack.
Icelandic: 1 stakri pakkningu
English: INFORMATION IN BRAILLE Kovaltry 1000
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI Kovaltry 1000
English: Holding the vial adapter in place, remove the syringe from the vial adapter (the adapter should remain attached to the vial).
Icelandic: 15. Haldið millistykki hettuglassins á sínum stað og fjarlægið sprautuna úr millistykkinu (millistykkið ætti að haldast fast við hettuglasið).
English: Haemorrhage
Icelandic: Sprautustimpil
English: Remove the protective cap from the vial (A).Wipe the rubber stopper on the vial with an alcohol swab and allow the stopper to air dry before use.
Icelandic: Þurrkið af gúmmítappa hettuglassins með sprittþurrku og leyfið tappanum að þorna fyrir notkun.
English: Kovaltry 3000 IU powder and solvent for solution for injection One mL Kovaltry 3000 IU contains approximately 600 IU (3000 IU / 5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Icelandic: Kovaltry 3000 a.e. stungulyfsstofn og leysir, lausn Einn ml af Kovaltry 3000 a.e. inniheldur u.þ.b. 600 a.e. (3.000 a.e. / 5 ml) af raðbrigða storkuþætti VIII úr mönnum (INN: októkóg alfa) eftir blöndun með vatni fyrir stungulyf.
English: INFORMATION IN BRAILLE Kovaltry 500
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI Kovaltry 500
English: STATEMENT OF ACTIVE SUBSTANCE(S) Kovaltry 1000 IU contains (1000 IU / 2.5 mL) = 400 IU octocog alfa per mL after reconstitution.
Icelandic: VIRK(T) EFNI Kovaltry 1000 a.e. inniheldur (1000 a.e. / 2,5 ml) = 400 a.e. októkóg alfa á hvern ml eftir blöndun.
English: Post-authorisation Efficacy Study: In order to investigate the safety and efficacy of long term treatment with Kovaltry, the MAH should submit the results of the ongoing study “13400 - Leopold Kids extension”
Icelandic: Kovaltry hjá sjúklingum sem ekki hafa áður fengið meðferð mun markaðsleyfishafi leggja fram niðurstöður rannsóknarinnar 13400-Leopold Kids, framhaldsrannsókn, sem enn stendur yfir.
English: How Kovaltry is given
Icelandic: Hvernig á að gefa Kovaltry
English: For children not previously treated with factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 patients).
Icelandic: Myndun mótefna gegn storkuþætti VIII getur verið mjög algeng (komið fram hjá fleiri en 1 af hverjum 10 sjúklingum) hjá börnum sem ekki hafa áður fengið meðferð með lyfjum sem innihalda storkuþátt VIII (sjá kafla 2).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Kovaltry 2000 IU contains (2000 IU / 5 mL) = 400 IU octocog alfa per mL after reconstitution.
Icelandic: VIRK(T) EFNI Kovaltry 2000 a.e. inniheldur (2000 a.e. / 5 ml) = 400 a.e. októkóg alfa á hvern ml eftir blöndun.
English: 32 IU/kg 50 IU/kg)
Icelandic: 32 a.e./kg 50 a.e./kg
English: previously developed factor VIII inhibitors to a different product.
Icelandic: þú hefur einhvern tímann myndað mótefni gegn storkuþætti VIII sem var í öðru lyfi.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 250 IU (octocog alfa) (100 IU/mL after reconstitution).
Icelandic: INNIHALD TILGREINT SEM ÞYNGD, RÚMMÁL EÐA FJÖLDI EININGA 250 a.e. (októkóg alfa) (100 a.e./ml eftir blöndun).
English: INFORMATION IN BRAILLE Kovaltry 3000
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI Kovaltry 3000
English: Peel off the paper cover on the plastic housing of the vial adapter.
Icelandic: Dragið pappírshlífina af plasthulstri millistykkisins fyrir hettuglasið.
English: • syringe plunger rod
Icelandic: • lausan stimpil
English: Kovaltry 2000 IU powder and solvent for solution for injection One mL Kovaltry 2000 IU contains approximately 400 IU (2000 IU / 5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Icelandic: Kovaltry 2000 a.e. stungulyfsstofn og leysir, lausn Einn ml af Kovaltry 2000 a.e. inniheldur u.þ.b. 400 a.e. (2.000 a.e. / 5 ml) af raðbrigða storkuþætti VIII úr mönnum (INN: októkóg alfa) eftir blöndun með vatni fyrir stungulyf.
English: Holding the adapter housing, place over the product vial and firmly press down (B).
Icelandic: Með því að halda í hulstur millistykkisins skal setja það yfir hettuglasið með lyfinu og ýta því þétt niður (B).
English: Inject the solvent by slowly pushing down on the plunger rod (G).
Icelandic: Dælið leysinum hægt inn með því að þrýsta hægt á stimplinn (G).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3000 IU (octocog alfa) (600 IU/mL after reconstitution).
Icelandic: INNIHALD TILGREINT SEM ÞYNGD, RÚMMÁL EÐA FJÖLDI EININGA 3000 a.e. (októkóg alfa) (600 a.e./ml eftir blöndun).
English: EU/1/15/1076/023 - 30 x (Kovaltry 2000 IU - solvent (5 mL); pre-filled syringe (5 mL))
Icelandic: EU/1/15/1076/023 - 30 x (Kovaltry 2000 a.e. - leysir (5 ml); áfyllt sprauta (5 ml))
English: Kovaltry 250 IU powder and solvent for solution for injection One mL Kovaltry 250 IU contains approximately 100 IU (250 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Icelandic: Einn ml af Kovaltry 250 a.e. inniheldur u.þ.b. 100 a.e. (250 a.e. / 2,5 ml) af raðbrigða storkuþætti VIII úr mönnum (INN: októkóg alfa) eftir blöndun með vatni fyrir stungulyf.
English: EU/1/15/1076/024 - 30 x (Kovaltry 3000 IU - solvent (5 mL); pre-filled syringe (5 mL))
Icelandic: EU/1/15/1076/024 - 30 x (Kovaltry 3000 a.e. - leysir (5 ml); áfyllt sprauta (5 ml))
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2000 IU (octocog alfa) (400 IU/mL after reconstitution).
Icelandic: INNIHALD TILGREINT SEM ÞYNGD, RÚMMÁL EÐA FJÖLDI EININGA 2000 a.e. (októkóg alfa) (400 a.e./ml eftir blöndun).
English: Life threatening haemorrhages
Icelandic: Eitt sett til bláæðarástungu
English: No symptoms of overdose with recombinant human coagulation factor VIII have been reported.
Icelandic: Ekki hefur verið greint frá neinum einkennum ofskömmtunar raðbrigða storkuþáttar VIII úr mönnum.
English: Kovaltry 1000 IU powder and solvent for solution for injection One mL Kovaltry 1000 IU contains approximately 400 IU (1000 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Icelandic: Kovaltry 1000 a.e. stungulyfsstofn og leysir, lausn Einn ml af Kovaltry 1000 a.e. inniheldur u.þ.b. 400 a.e. (1.000 a.e. / 2,5 ml) af raðbrigða storkuþætti VIII úr mönnum (INN: októkóg alfa) eftir blöndun með vatni fyrir stungulyf.
English: Kovaltry 500 IU powder and solvent for solution for injection One mL Kovaltry 500 IU contains approximately 200 IU (500 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Icelandic: Einn ml af Kovaltry 500 a.e. inniheldur u.þ.b. 200 a.e. (500 a.e. / 2,5 ml) af raðbrigða storkuþætti VIII úr mönnum (INN: októkóg alfa) eftir blöndun með vatni fyrir stungulyf.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 IU (octocog alfa) (200 IU/mL after reconstitution).
Icelandic: INNIHALD TILGREINT SEM ÞYNGD, RÚMMÁL EÐA FJÖLDI EININGA 500 a.e. (októkóg alfa) (200 a.e./ml eftir blöndun).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1000 IU (octocog alfa) (400 IU/mL after reconstitution).
Icelandic: INNIHALD TILGREINT SEM ÞYNGD, RÚMMÁL EÐA FJÖLDI EININGA 1000 a.e. (októkóg alfa) (400 a.e./ml eftir blöndun).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF A SINGLE PACK (INCLUDING BLUE BOX)
Icelandic: YTRI UMBÚÐUM YTRI ASKJA STAKRAR PAKKNINGAR (með BLUE BOX)
English: How Kovaltry is prepared for administration
Icelandic: Undirbúningur Kovaltry fyrir lyfjagjöf
English: What you need to know before you use Kovaltry
Icelandic: Áður en byrjað er að nota Kovaltry
English: The most serious side effects are allergic reactions or severe allergic reaction.Stop injecting Kovaltry immediately and speak to your doctor at once if such reactions occur.
Icelandic: Kovaltry samstundis og hafið strax samband við lækninn ef slík viðbrögð koma fram.
English: Treatment with Kovaltry will be started by a doctor who is experienced in the care of patients with haemophilia A. Always use this medicine exactly as described in this leaflet and as your doctor or pharmacist has told you.
Icelandic: Notið lyfið alltaf eins og fram kemur í fylgiseðlinum og eins og læknirinn eða lyfjafræðingur hefur sagt til um.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1076/008 - 1 x (Kovaltry 2000 IU - solvent (5 mL); pre-filled syringe (5 mL)) 13.
Icelandic: MARKAÐSLEYFISNÚMER EU/1/15/1076/008 - 1 x (Kovaltry 2000 a.e. - leysir (5 ml); áfyllt sprauta (5 ml))
English: common
Icelandic: Limited
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE WITH WATER FOR INJECTIONS NAME OF THE MEDICINAL PRODUCT AND IF NECESSARY ROUTE(S) OF ADMINISTRATION water for injections METHOD OF ADMINISTRATION EXPIRY DATE
Icelandic: OG ÍKOMULEIÐ(IR) vatn fyrir stungulyf AÐFERÐ VIÐ LYFJAGJÖF FYRNINGARDAGSETNING
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Kovaltry 250 IU powder for solution for injection recombinant human coagulation factor VIII (octocog alfa) Intravenous use.
Icelandic: HEITI LYFS OG ÍKOMULEIÐ(IR) Kovaltry 250 a.e. stungulyfsstofn, lausn raðbrigða manna storkuþáttur VIII (októkóg alfa)
English: Vascular disorders
Icelandic: Stungulyfsstofn
English: The solvent is a clear liquid.
Icelandic: Leysirinn er tær vökvi.
English: Hold the pre filled syringe of solvent upright.
Icelandic: Haldið áfylltu sprautunni með leysinum uppréttri.
English: PHARMACEUTICAL FORM AND CONTENTS powder and solvent for solution for injection
Icelandic: AÐFERÐ VIÐ LYFJAGJÖF OG ÍKOMULEIÐ(IR)
English: EU/1/15/1076/017 - 30 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/018 - 30 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (5 mL))
Icelandic: EU/1/15/1076/017 - 30 x (Kovaltry 250 a.e. - leysir (2,5 ml); áfyllt sprauta (3 ml)) EU/1/15/1076/018 - 30 x (Kovaltry 250 a.e. - leysir (2,5 ml); áfyllt sprauta (5 ml))
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1076/010 - 1 x (Kovaltry 3000 IU - solvent (5 mL); pre-filled syringe (5 mL)) 13.
Icelandic: MARKAÐSLEYFISNÚMER EU/1/15/1076/010 - 1 x (Kovaltry 3000 a.e. - leysir (5 ml); áfyllt sprauta (5 ml))
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1076/024 - 30 x (Kovaltry 3000 IU - solvent (5 mL); pre-filled syringe (5 mL)) 13.
Icelandic: MARKAÐSLEYFISNÚMER EU/1/15/1076/024 - 30 x (Kovaltry 3000 a.e. - leysir (5 ml); áfyllt sprauta (5 ml))
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Kovaltry 3000 IU powder for solution for injection recombinant human coagulation factor VIII (octocog alfa) Intravenous use.
Icelandic: HEITI LYFS OG ÍKOMULEIÐ(IR) Kovaltry 3000 a.e. stungulyfsstofn, lausn raðbrigða manna storkuþáttur VIII (októkóg alfa)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Kovaltry 500 IU powder for solution for injection recombinant human coagulation factor VIII (octocog alfa) Intravenous use.
Icelandic: HEITI LYFS OG ÍKOMULEIÐ(IR) Kovaltry 500 a.e. stungulyfsstofn, lausn raðbrigða manna storkuþáttur VIII (októkóg alfa)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Kovaltry 2000 IU powder for solution for injection recombinant human coagulation factor VIII (octocog alfa) Intravenous use.
Icelandic: HEITI LYFS OG ÍKOMULEIÐ(IR) Kovaltry 2000 a.e. stungulyfsstofn, lausn raðbrigða manna storkuþáttur VIII (októkóg alfa)
English: EU/1/15/1076/006 - 1 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/016 - 1 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (5 mL))
Icelandic: EU/1/15/1076/006 - 1 x (Kovaltry 1000 a.e. - leysir (2,5 ml); áfyllt sprauta (3 ml)) EU/1/15/1076/016 - 1 x (Kovaltry 1000 a.e. - leysir (2,5 ml); áfyllt sprauta (5 ml))
English: EU/1/15/1076/002 - 1 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/012 - 1 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (5 mL))
Icelandic: EU/1/15/1076/002 - 1 x (Kovaltry 250 a.e. - leysir (2,5 ml); áfyllt sprauta (3 ml)) EU/1/15/1076/012 - 1 x (Kovaltry 250 a.e. - leysir (2,5 ml); áfyllt sprauta (5 ml))
English: EU/1/15/1076/021 - 30 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/022 - 30 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (5 mL))
Icelandic: EU/1/15/1076/021 - 30 x (Kovaltry 1000 a.e. - leysir (2,5 ml); áfyllt sprauta (3 ml)) EU/1/15/1076/022 - 30 x (Kovaltry 1000 a.e. - leysir (2,5 ml); áfyllt sprauta (5 ml))
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1076/023 - 30 x (Kovaltry 2000 IU - solvent (5 mL); pre-filled syringe (5 mL)) 13.
Icelandic: MARKAÐSLEYFISNÚMER EU/1/15/1076/023 - 30 x (Kovaltry 2000 a.e. - leysir (5 ml); áfyllt sprauta (5 ml))
English: EU/1/15/1076/004 - 1 x (Kovaltry 500 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/014 - 1 x (Kovaltry 500 IU - solvent (2.5 mL); pre-filled syringe (5 mL))
Icelandic: EU/1/15/1076/004 - 1 x (Kovaltry 500 a.e. - leysir (2,5 ml); áfyllt sprauta (3 ml)) EU/1/15/1076/014 - 1 x (Kovaltry 500 a.e. - leysir (2,5 ml); áfyllt sprauta (5 ml))