FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients under the age of 6, doses of 20 to 50 IU of factor VIII per kg body weight 3 to 4 times weekly are recommended for prophylactic therapy.
Icelandic: Fyrir sjúklinga yngri en 6 ára, í fyrirbyggjandi meðferð, er mælt með skammti 20-50 a.e. af storkuþætti VIII á hvert kg líkamsþyngdar 3-4 sinnum í viku.
English: - For administration the use of a luer-lock syringe is required.
Icelandic: - Fyrir lyfjagjöf þarf að nota sprautu með Luer-læsingu.
English: Draw the reconstituted solution into the syringe by pulling the plunger back slowly.
Icelandic: Dragið lyfjablönduna upp í sprautuna með því að draga stimpilinn rólega út.
English: The following table 2 provides the frequency of adverse drug reactions in clinical trials and from spontaneous reporting.
Icelandic: Eftirfarandi tafla 2 sýnir tíðni aukaverkana í klínískum rannsóknum og tilkynningu um aukaverkanir eftir markaðssetningu.
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis.
Icelandic: Upplýsa skal sjúklinga um fyrstu einkenni ofnæmisviðbragða, þ.m.t. ofsakláða, útbreiddan ofsakláða, þyngsli fyrir brjósti, hvæsandi öndun, lágþrýsting og bráðaofnæmi.
English: - ADVATE in BAXJECT III system: Each pack contains a ready to use BAXJECT III system in a sealed blister (the powder vial and the vial containing 5 ml solvent are preassembled with the system for reconstitution).
Icelandic: BAXJECT III-kerfi í innsiglaðri þynnupakkningu sem er tilbúið til notkunar (hettuglasið með stungulyfsstofninum og hettuglasið sem inniheldur 5 ml af leysi eru forsamsett við blöndunarkerfið).
English: Remove the blue cap from BAXJECT III.
Icelandic: Fjarlægið bláu hettuna af BAXJECT III.
English: INFORMATION IN BRAILLE ADVATE 250
Icelandic: HEITI LYFS ADVATE 250
English: INFORMATION IN BRAILLE ADVATE 1000
Icelandic: HEITI LYFS ADVATE 1000
English: Steady State (dl/kg)
Icelandic: Dreifingarrúmmál við stöðugt ástand (dl/kg)
English: INFORMATION IN BRAILLE ADVATE 2000
Icelandic: HEITI LYFS ADVATE 2000
English: Fig. e
Icelandic: Mynd e
English: Remove the blue cap from BAXJECT II / BAXJECT III.
Icelandic: Fjarlægið bláu hettuna af BAXJECT II/BAXJECT III.
English: Eye inflammation
Icelandic: Hjartsláttarónot
English: Pyrexia
Icelandic: Baxalta
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (BAXJECT II DEVICE)
Icelandic: SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM YTRI ASKJA (BAXJECT II-BÚNAÐUR)
English: Memory impairment
Icelandic: Skurðaðgerð Minniháttar
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
Icelandic: Leiðbeiningar um eigin lyfjagjöf Smitgát er nauðsynleg við lyfjagjöf.
English: - ADVATE in BAXJECT III system: Each pack contains a ready to use BAXJECT III system in a sealed blister (the powder vial and the vial containing 2 ml solvent are preassembled with the system for reconstitution).
Icelandic: BAXJECT III-kerfi í innsiglaðri þynnupakkningu sem er tilbúið til notkunar (hettuglasið með stungulyfsstofninum og hettuglasið sem inniheldur 2 ml af leysi eru forsamsett við blöndunarkerfið).
English: Degree of haemorrhage/type of surgical procedure
Icelandic: Stig blæðingar / tegund skurðaðgerðar
English: Repeat injections every 8 to 24 hours (6 to 24 hours for patients under the age of 6) until adequate wound healing, then continue therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dl).
Icelandic: Meðferð skal síðan haldið áfram í 7 daga til viðbótar til að viðhalda virkni storkuþáttar VIII í 30-60% (a.e./dl).
English: Individual patients may vary in their response to factor VIII, achieving different levels of in vivo recovery and demonstrating different half-lives.
Icelandic: Svörun við gjöf storkuþáttar VIII getur verið mjög mismunandi milli sjúklinga, bæði hvað varðar bata in vivo og helmingunartíma.
English: After reconstitution, from a microbiological point of view, the product should be used immediately.
Icelandic: Frá örverufræðilegu sjónarmiði ætti að nota lyfið strax eftir blöndun.
English: Related to central venous access devices (CVAD) catheter-related infection, systemic infection and local blood clot at the catheter site.
Icelandic: Tengdar miðlægum bláæðahollegg (CVAD) sýkingar tengdar æðalegg, altækar sýkingar og staðbundinn blóðkökkur á holleggsstað.
English: Repeat injections every 12 to 24 hours (8 to 24 hours for patients under the age of 6) for 3 - 4 days or more until pain and acute disability are resolved.
Icelandic: Endurtakið inndælingu á 12-24 klst. fresti (8-24 klst. fresti hjá sjúklingum yngri en 6 ára) í 3-4 daga eða lengur þar til sársauki minnkar og bráð fötlun er gengin til baka.
English: Keep the blister with the product in the outer carton in order to protect from light.
Icelandic: Geymið þynnupakkninguna með lyfinu í ytri umbúðum til varnar gegn ljósi.
English: The product contains traces of mouse and hamster proteins.
Icelandic: Lyfið inniheldur leifar af prótínum úr músum og hömstrum.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 2000 IU octocog alfa, approx. 400 IU/ml after reconstitution.
Icelandic: 1 hettuglas: 2000 a.e. octocog alfa, um það bil 400 a.e./ml eftir blöndun.
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of plasma factor VIII activity assay is indispensable.
Icelandic: Þegar um er að ræða stærri skurðaðgerðir er nauðsynlegt að viðhafa nákvæma stjórnun á uppbótarmeðferðinni.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 250 IU octocog alfa, approx. 125 IU/ml after reconstitution.
Icelandic: 1 hettuglas: 250 a.e. octocog alfa, um það bil 125 a.e./ml eftir blöndun.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2000 IU octocog alfa
Icelandic: INNIHALD TILGREINT SEM ÞYNGD, RÚMMÁL EÐA FJÖLDI EININGA 2000 a.e. octocog alfa
English: Remove the blue cap from BAXJECT II.
Icelandic: Fjarlægið bláu hettuna af BAXJECT II.
English: Powder vial and 2 ml solvent preassembled in BAXJECT III system.
Icelandic: Hettuglas með stungulyfsstofni og 2 ml leysi eru forsamsett í BAXJECT III-kerfinu.
English: In case of shock, standard medical treatment for shock should be implemented.
Icelandic: Ef um lost er að ræða skal beita staðlaðri meðferð við losti.
English: During the shelf life the blister with the product may be kept at room temperature (up to 25 °C) for a single period not exceeding 6 months.
Icelandic: Á endingartíma þynnupakkningarinnar með lyfinu má geyma það við stofuhita (allt að 25 °C) í eitt sex mánaða tímabil.
English: Powder vial and 5 ml solvent preassembled in BAXJECT III system.
Icelandic: Hettuglas með stungulyfsstofni og 5 ml leysi eru forsamsett í BAXJECT III-kerfinu.
English: With BAXJECT II attached to the solvent vial, invert the system so that the solvent vial is on top of the device.
Icelandic: Hvolfið leysisglasinu með áföstu BAXJECT II, þannig að leysisglasið sé yfir búnaðinum.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER LABEL (BAXJECT III SYSTEM)
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á ÞYNNUM EÐA STRIMLUM MERKIMIÐI Á ÞYNNU (BAXJECT III-KERFI)
English: The pulse rate should be determined before and during administration of ADVATE.
Icelandic: Mæla skal hjartsláttartíðni bæði fyrir innrennsli ADVATE og á meðan á því stendur.
English: Volume of
Icelandic: Fjölgun einkjörnunga
English: • Inspect the prepared solution for particulate matter and discoloration prior to administration (the solution should be clear, colourless and free from foreign particles).
Icelandic: Skoðið tilbúna lausn fyrir lyfjagjöf með tilliti til litabreytinga og agna (lausnin á að vera tær, litlaus og laus við aðskotaagnir).
English: Haematocrit decreased
Icelandic: Minnkun storkuþáttar VIIIb
English: - ADVATE with BAXJECT II device: Each pack contains a powder vial, a vial containing 2 ml solvent and a device for reconstitution (BAXJECT II).
Icelandic: Hver pakkning inniheldur hettuglas með stungulyfsstofni, hettuglas sem inniheldur 2 ml af leysi og búnað fyrir blöndun (BAXJECT II).
English: The rate of administration should be determined to ensure the comfort of the patient up to a maximum of 10 ml/min.
Icelandic: Hraði lyfjagjafar skal vera þannig að sjúklingurinn verði ekki fyrir óþægindum, allt að 10 ml/mín.
English: Laryngitis
Icelandic: Margúll
English: Therefore, caution is advised during injection of ADVATE reconstituted in 2 ml sterilised water for injections, especially in children.
Icelandic: á ADVATE sem er blandað með 2 ml af sæfðu vatni fyrir stungulyf, sér í lagi hjá börnum.
English: - ADVATE with BAXJECT II device: Each pack contains a powder vial, a vial containing 5 ml solvent and a device for reconstitution (BAXJECT II).
Icelandic: Hver pakkning inniheldur hettuglas með stungulyfsstofni, hettuglas sem inniheldur 5 ml af leysi og búnað fyrir blöndun (BAXJECT II).
English: Respiratory, thoracic and mediastinal disorders Dyspnoea
Icelandic: Öndunarfæri, brjósthol og miðmæti
English: Instructions for injection For administration the use of a luer-lock syringe is required.
Icelandic: Við lyfjagjöf þarf að nota sprautu með Luer-læsingu.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3000 IU octocog alfa
Icelandic: INNIHALD TILGREINT SEM ÞYNGD, RÚMMÁL EÐA FJÖLDI EININGA 3000 a.e. octocog alfa
English: Table 2 Frequency of adverse drug reactions (ADRs) in clinical trials and from spontaneous reports MedDRA Standard System Organ Class
Icelandic: Tafla 2 Tíðni aukaverkana í klínískum rannsóknum og tilkynningar eftir markaðssetningu
English: Laboratory test abnormal
Icelandic: Óeðlilegar rannsóknarniðurstöður
English: d) 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: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 1000 IU octocog alfa, approx. 200 IU/ml after reconstitution.
Icelandic: 1 hettuglas: 1000 a.e. octocog alfa, um það bil 200 a.e./ml eftir blöndun.
English: Half-life (h) Maximum Plasma Concentration Post Infusion (IU/dl) Mean Residence Time (h)
Icelandic: Helmingunartími (klst.) Hámarksþéttni í blóði eftir inndælingu (a.e./dl)
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 1000 IU octocog alfa, approx. 500 IU/ml after reconstitution.
Icelandic: 1 hettuglas: 1000 a.e. octocog alfa, um það bil 500 a.e./ml eftir blöndun.
English: Place the vials on a flat clean surface.
Icelandic: Látið glösin standa á hreinu sléttu undirlagi.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 250 IU octocog alfa
Icelandic: INNIHALD TILGREINT SEM ÞYNGD, RÚMMÁL EÐA FJÖLDI EININGA 250 a.e. octocog alfa
English: Powder: White to off-white friable powder.
Icelandic: Hvítt til beinhvítt auðmulið duft.
English: End of 6 month period, if stored at room temperature: Do not use after the expiry date.
Icelandic: Í lok 6 mánaða tímabils ef það er geymt við stofuhita:
English: Minor
Icelandic: Börn
English: Discard any unused solution appropriately.
Icelandic: Fargið afgangslausn á viðeigandi hátt.
English: Major
Icelandic: Stærri
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1500 IU octocog alfa
Icelandic: INNIHALD TILGREINT SEM ÞYNGD, RÚMMÁL EÐA FJÖLDI EININGA 1500 a.e. octocog alfa
English: ADVATE is to be administered intravenously after reconstitution of the product.
Icelandic: ADVATE skal gefið í bláæð eftir blöndun stofnsins.
English: Adjusted Incremental
Icelandic: Bráðaofnæmi
English: Therefore, caution is advised during injection of ADVATE reconstituted in 2 ml, especially in children.
Icelandic: á ADVATE sem er blandað með 2 ml, sér í lagi hjá börnum.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1000 IU octocog alfa
Icelandic: INNIHALD TILGREINT SEM ÞYNGD, RÚMMÁL EÐA FJÖLDI EININGA 1000 a.e. octocog alfa
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ASSEMBLY LABEL (BAXJECT III SYSTEM)
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á ÞYNNUM EÐA STRIMLUM MERKIMIÐI Á SAMSETTU KERFI (BAXJECT III-KERFI)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (BAXJECT III SYSTEM)
Icelandic: SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM YTRI ASKJA (BAXJECT III-KERFI)
English: Each vial contains nominally 2000 IU human coagulation factor VIII (rDNA), octocog alfa.
Icelandic: Hvert hettuglas inniheldur að 2000 a.e. af storkuþætti VIII (rDNA) úr mönnum, octocog alfa.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 250 IU octocog alfa, approx. 50 IU/ml after reconstitution.
Icelandic: 1 hettuglas: 250 a.e. octocog alfa, um það bil 50 a.e./ml eftir blöndun.
English: Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), octocog alfa.
Icelandic: Hvert hettuglas inniheldur að 250 a.e. af storkuþætti VIII (rDNA) úr mönnum, octocog alfa.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 250 IU powder and solvent for solution for injection Octocog alfa
Icelandic: ADVATE 250 a.e. stungulyfsstofn og leysir, lausn Octocog alfa
English: During the course of treatment, appropriate determination of plasma factor VIII levels is advised to guide the dose to be administered and the frequency of repeated injections.
Icelandic: Meðan á meðferð stendur er mælt með því að gerðar séu viðeigandi mælingar á storkuþætti VIII í blóði til ákvörðunar nauðsynlegra skammta og tíðni endurtekinna lyfjagjafa.
English: ADVATE 250 IU powder and solvent for solution for injection
Icelandic: ADVATE 250 a.e. stungulyfsstofn og leysir, lausn.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 2000 IU powder and solvent for solution for injection Octocog alfa
Icelandic: ADVATE 2000 a.e. stungulyfsstofn og leysir, lausn Octocog alfa
English: ADVATE contains approximately 125 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Icelandic: ADVATE inniheldur um það bil 125 a.e. í ml af storkuþætti VIII (rDNA) úr mönnum, octocog alfa eftir blöndun.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/016
Icelandic: MARKAÐSLEYFISNÚMER EU/1/03/271/016
English: NAME OF THE MEDICINAL PRODUCT ADVATE 2000
Icelandic: ADVATE 2000
English: Each vial contains nominally 3000 IU human coagulation factor VIII (rDNA), octocog alfa.
Icelandic: Hvert hettuglas inniheldur að 3000 a.e. af storkuþætti VIII (rDNA) úr mönnum, octocog alfa.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 IU octocog alfa
Icelandic: INNIHALD TILGREINT SEM ÞYNGD, RÚMMÁL EÐA FJÖLDI EININGA 500 a.e. octocog alfa
English: Volume of Distribution at
Icelandic: MedDRAFlokkun eftir líffærum
English: ADVATE contains approximately 750 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Icelandic: ADVATE inniheldur um það bil 750 a.e. í ml af storkuþætti VIII (rDNA) úr mönnum, octocog alfa eftir blöndun.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 1500
Icelandic: ADVATE 1500
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 1500 IU octocog alfa, approx. 750 IU/ml after reconstitution.
Icelandic: 1500 a.e. octocog alfa, um það bil 750 a.e./ml eftir blöndun.
English: Keep the vial in the outer carton in order to protect from light.
Icelandic: Geymið innsigluðu þynnupakkninguna í ytri kassanum til varnar gegn ljósi.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 3000 IU octocog alfa, approx. 600 IU/ml after reconstitution.
Icelandic: 3000 a.e. octocog alfa, um það bil 600 a.e./ml eftir blöndun.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 1000 IU powder and solvent for solution for injection Octocog alfa
Icelandic: ADVATE 1000 a.e. stungulyfsstofn og leysir, lausn Octocog alfa
English: What you need to know before you use ADVATE
Icelandic: Áður en byrjað er að nota ADVATE
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/008
Icelandic: MARKAÐSLEYFISNÚMER EU/1/03/271/008
English: NAME OF THE MEDICINAL PRODUCT ADVATE 500 IU powder and solvent for solution for injection Octocog alfa
Icelandic: ADVATE 500 a.e. stungulyfsstofn og leysir, lausn Octocog alfa
English: (see section 4.2 for information on paediatric use).
Icelandic: (sjá kafla 4.4. og 4.8).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/006
Icelandic: MARKAÐSLEYFISNÚMER EU/1/03/271/006
English: Each vial contains nominally 1500 IU human coagulation factor VIII (rDNA), octocog alfa.
Icelandic: Hvert hettuglas inniheldur að 1500 a.e. af storkuþætti VIII (rDNA) úr mönnum, octocog alfa.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 1500 IU octocog alfa, approx. 300 IU/ml after reconstitution.
Icelandic: 1500 a.e. octocog alfa, um það bil 300 a.e./ml eftir blöndun.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/018
Icelandic: MARKAÐSLEYFISNÚMER EU/1/03/271/018
English: NAME OF THE MEDICINAL PRODUCT ADVATE 3000 IU powder and solvent for solution for injection Octocog alfa
Icelandic: ADVATE 3000 a.e. stungulyfsstofn og leysir, lausn Octocog alfa
English: NAME OF THE MEDICINAL PRODUCT ADVATE 1500 IU powder and solvent for solution for injection Octocog alfa
Icelandic: ADVATE 1500 a.e. stungulyfsstofn og leysir, lausn Octocog alfa
English: Name and address of the manufacturers of the biological active substance
Icelandic: Heiti og heimilisfang framleiðenda líffræðilegs/líffræðilegra virks/virkra efnis/efna.
English: • Do not use if the BAXJECT II device, its sterile barrier system or its packaging is damaged or shows any sign of deterioration as indicated by the symbol: • Do not refrigerate the solution after preparation.
Icelandic: Notið ekki eftir fyrningardagsetningu sem er á miðunum og öskjunni. • Má ekki nota ef BAXJECT II-búnaðurinn, sæfingarinnsigli eða umbúðir eru skemmd eða virðast ekki í lagi., eins og bent er á með tákninu: •
English: Each vial contains nominally 1000 IU human coagulation factor VIII (rDNA), octocog alfa.
Icelandic: Hvert hettuglas inniheldur að 1000 a.e. af storkuþætti VIII (rDNA) úr mönnum, octocog alfa.
English: ADVATE contains approximately 500 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Icelandic: ADVATE inniheldur um það bil 500 a.e. í ml af storkuþætti VIII (rDNA) úr mönnum, octocog alfa eftir blöndun.
English: ADVATE should be administered via the intravenous route.
Icelandic: ADVATE skal gefið í æð eftir blöndun stofnsins.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/012
Icelandic: MARKAÐSLEYFISNÚMER EU/1/03/271/012
English: Malaise
Icelandic: Slappleiki
English: Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), octocog alfa.
Icelandic: Hvert hettuglas inniheldur að 500 a.e. af storkuþætti VIII (rDNA) úr mönnum, octocog alfa.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Icelandic: Hvernig geyma á ADVATE Geymið lyfið þar sem börn hvorki ná til né sjá.
English: ADVATE contains approximately 100 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Icelandic: ADVATE inniheldur um það bil 100 a.e. í ml af storkuþætti VIII (rDNA) úr mönnum, octocog alfa eftir blöndun.
English: ADVATE contains approximately 400 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Icelandic: ADVATE inniheldur um það bil 400 a.e. í ml af storkuþætti VIII (rDNA) úr mönnum, octocog alfa eftir blöndun.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products or solvents.
Icelandic: Ekki má blanda þessu lyfi saman við önnur lyf eða aðra leysa þar sem rannsóknir á samrýmanleika hafa ekki verið gerðar.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/011
Icelandic: MARKAÐSLEYFISNÚMER EU/1/03/271/011
English: How ADVATE is given
Icelandic: Hvernig gefa á ADVATE
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/017
Icelandic: MARKAÐSLEYFISNÚMER EU/1/03/271/017
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/015
Icelandic: MARKAÐSLEYFISNÚMER EU/1/03/271/015
English: Instructions for preparation and administration
Icelandic: Leiðbeiningar fyrir blöndun og lyfjagjöf
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 2000 IU octocog alfa and 1 vial with 5 ml sterilised water for injections preassembled in BAXJECT III system.
Icelandic: 1 hettuglas með 2000 a.e. af octocog alfa og 1 hettuglas með 5 ml af vatni fyrir stungulyf, forsamsett í BAXJECT III-kerfi.
English: During the shelf life, the product may be kept at room temperature (up to 25 °C) for a single period not exceeding 6 months.
Icelandic: Á endingartíma lyfsins má geyma það við stofuhita (allt að 25 °C) í eitt sex mánaða tímabil að hámarki.
English: Infusion (IU/dl)
Icelandic: Hámarksþéttni í blóði eftir inndælingu (a.e./dl)
English: Pruritus
Icelandic: Ofsviti
English: ADVATE contains approximately 300 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Icelandic: ADVATE inniheldur um það bil 300 a.e. í ml af storkuþætti VIII (rDNA) úr mönnum, octocog alfa eftir blöndun.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/009
Icelandic: MARKAÐSLEYFISNÚMER EU/1/03/271/009
English: PHARMACEUTICAL FORM Powder and solvent for solution for injection.
Icelandic: Smitgát er nauðsynleg við blöndun og lyfjagjöf.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 500 IU octocog alfa, approx. 250 IU/ml after reconstitution.
Icelandic: 500 a.e. octocog alfa, um það bil 250 a.e./ml eftir blöndun.
English: B CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2)
Icelandic: B. FORSENDUR FYRIR, EÐA TAKMARKANIR Á, AFGREIÐSLU OG NOTKUN Ávísun lyfsins er háð sérstökum takmörkunum (sjá viðauka I:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/010
Icelandic: MARKAÐSLEYFISNÚMER EU/1/03/271/010
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/014
Icelandic: MARKAÐSLEYFISNÚMER EU/1/03/271/014
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 2000 IU octocog alfa, 1 vial with 5 ml sterilised water for injections, 1 BAXJECT II device.
Icelandic: 1 hettuglas með 2000 a.e. af octocog alfa, 1 hettuglas með 5 ml af vatni fyrir stungulyf, 1 BAXJECT II-búnaður.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 500 IU octocog alfa, approx. 100 IU/ml after reconstitution.
Icelandic: 500 a.e. octocog alfa, um það bil 100 a.e./ml eftir blöndun.
English: EXP:
Icelandic: Innihald:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/019
Icelandic: MARKAÐSLEYFISNÚMER EU/1/03/271/019
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/005
Icelandic: MARKAÐSLEYFISNÚMER EU/1/03/271/005
English: ADVATE contains approximately 200 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Icelandic: ADVATE inniheldur um það bil 200 a.e. í ml af storkuþætti VIII (rDNA) úr mönnum, octocog alfa eftir blöndun.
English: ADVATE contains approximately 600 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Icelandic: ADVATE inniheldur um það bil 600 a.e. í ml af storkuþætti VIII (rDNA) úr mönnum, octocog alfa eftir blöndun.
English: Reconstitution with the BAXJECT II device - For reconstitution use only the sterilised water for injections and the reconstitution device provided in the pack.
Icelandic: Við blöndun skal aðeins nota sæfða vatnið fyrir stungulyf og blöndunarbúnaðinn sem fylgja í pakkningunni.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/020
Icelandic: MARKAÐSLEYFISNÚMER EU/1/03/271/020
English: Post procedural haemorrhage
Icelandic: 15. NOTKUNARLEIÐBEININGAR
English: Life threatening haemorrhages.
Icelandic: Verkur í efri hluta kviðarhols
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 3000 IU octocog alfa and 1 vial with 5 ml sterilised water for injections preassembled in BAXJECT III system.
Icelandic: 1 hettuglas með 3000 a.e. af octocog alfa og 1 hettuglas með 5 ml af vatni fyrir stungulyf, forsamsett í BAXJECT III-kerfi.