FrancophonIA/ELRC3.0 huggingface dataset:
English: Respiratory, thoracic and mediastinal disorders Very rare:
Icelandic: Öndunarfæri, brjósthol og miðmæti Koma örsjaldan fyrir:
English: GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) should not be mixed with other medicines in the same injection.
Icelandic: GONAL-f 450 a.e./0,75 ml (33 míkrógrömm /0,75 ml) skal ekki blanda saman við önnur lyf í sömu inndælingu.
English: In general adequate follicular development is achieved on average by the tenth day of treatment (range 5 to 20 days).
Icelandic: örvun eggbúa eftir u.þ.b. 10 daga (milli 5-20 dagar).
English: The pen contains 450 IU follitropin alpha.
Icelandic: Hvert hettuglas inniheldur 450 a.e. af follitrópíni alfa.
English: Note: The 300 IU pen maximum single-dose setting is 300 IU; the 450 IU pen maximum single-dose setting is 450 IU; the 900 IU pen maximum single-dose setting is 450 IU.
Icelandic: 300 a.e. lyfjapennans fyrir stakan skammt er 300 a.e.; Hámarksstilling 450 a.e. lyfjapennans fyrir stakan skammt er 450 a.e.; Hámarksstilling
English: Turn the dose setting knob forward to dial up Turn the dose setting knob backward to correct the dose
Icelandic: Snúðu skammtastillinum til baka til þess að upp á við leiðrétta skammt
English: Each multidose vial contains 87 micrograms follitropin alfa equivalent to 1200 IU.
Icelandic: Hvert fjölskammta hettuglas inniheldur 87 míkrógrömm af follitrópíni alfa sem jafngildir 1.200 a.e. Hver ml af blandaðri lausn inniheldur 600 a.e.
English: Contains: One pre-filled syringe of solvent contains: 2 mL water for injections, benzyl alcohol 0.9%.
Icelandic: Ein áfyllt sprauta af leysi inniheldur 2 ml af vatni fyrir stungulyf og 0,9% bensýlalkóhól.
English: • This vial contains several doses of GONAL-f. You will have to keep it several days and only draw the prescribed dose every day.
Icelandic: Þú þarft að geyma það í nokkra daga og draga eingöngu upp ávísaðan skammt dag hvern.
English: Phosphoric acid, concentrated Sodium hydroxide
Icelandic: óþynnt fosfórsýra og natríumhýdroxíð.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.75 mL/pre-filled syringe
Icelandic: INNIHALD TILGREINT SEM ÞYNGD, RÚMMÁL EÐA FJÖLDI EININGA 0,75 ml/ áfyllt sprauta
English: Warning: Please read these instructions for use before using your GONAL-f pre-filled pen.
Icelandic: Lestu þessar leiðbeiningar áður en GONAL-f áfyllti lyfjapenninn er notaður.
English: • Each vial contains 600 IU of follitropin alfa.
Icelandic: Hvert hettuglas inniheldur 600 a.e. af follitrópíni alfa.
English: Verify that the Dose Feedback Window is set to "0".
Icelandic: 4.2. Gakktu úr skugga um að skammtaglugginn sé stilltur á „0“.
English: 1 pre-filled syringe of 2 mL solvent.
Icelandic: 1 áfyllt sprauta með 2 ml af leysi.
English: EU/1/95/001/026 5 vials of powder for solution for injection.
Icelandic: EU/1/95/001/026/ 5 hettuglös með stungulyfsstofn, lausn.
English: CAUTION:
Icelandic: Varúð:
English: GONAL-f 75 IU (5.5 micrograms) powder and solvent for solution for injection Follitropin alfa
Icelandic: GONAL-f 75 a.e. (5,5 míkrógrömm), stungulyfsstofn og leysir, lausn Follitrópín alfa
English: For example, following two weeks of treatment with an agonist, 150-225 IU GONAL-f are administered for the first 7 days.
Icelandic: Til dæmis eru gefnar 150-225 a.e. af GONAL-f fyrstu sjö dagana eftir tveggja vikna meðferðina með örvanum.
English: GONAL-f 1050 IU/1.75 mL (77 micrograms/1.75 mL) should not be mixed with other medicines in the same injection.
Icelandic: -f 1050 a.e./1,75 ml (77 míkrógrömm/1,75 ml) skal ekki blanda saman við önnur lyf í sömu inndælingu.
English: Dispose of the used needle safely.
Icelandic: Fargaðu notuðu nálinni á öruggan hátt.
English: GONAL-f pre-filled pen Treatment Diary
Icelandic: Meðferðardagbók fyrir GONAL-f áfylltan lyfjapenna
English: • Turn the vial upside down and gently draw the solution back into the syringe by pulling the plunger.
Icelandic: Snúðu glasinu upp og dragðu lausnina varlega til baka í sprautuna með því að toga í stimpilinn.
English: Contains: One pre-filled syringe of solvent contains: 1 mL water for injections, benzyl alcohol 0.9%.
Icelandic: Ein áfyllt sprauta af leysi inniheldur 1 ml af vatni fyrir stungulyf og 0,9% bensýlalkóhól.
English: PARTICULARS TO APPEAR ON THE PEN GONAL-f 900 IU/1.5 mL
Icelandic: SEM KOMA EIGA FRAM Á LYFJAPENNANUM GONAL-f 900 a.e./1,5 ml
English: Very rarely, severe OHSS may be complicated by ovarian torsion or thromboembolic events such as pulmonary embolism, ischaemic stroke or myocardial infarction.
Icelandic: Örsjaldan geta fylgt alvarlegu oförvunarheilkenni eggjastokka eggjastokksvindingur og segarek, svo sem lungnasegarek, heilablóðfall eða hjartadrep.
English: See section 4.
Icelandic: 6. Farðu yfir í kafla 5:
English: Pack of one pre-filled pen and 20 needles to be used with the pen for administration.
Icelandic: 1 áfylltan lyfjapenna og 20 nálar sem nota á með lyfjapennanum við inndælingu.
English: In ART, GONAL-f at a lower total dose and shorter treatment period than urinary FSH, resulted in a higher number of oocytes retrieved when compared to urinary FSH.
Icelandic: Við tæknifrjóvgun leiddi notkun GONAL-f í lægri heildarskömmtum og meðferð í styttri tíma en FSH unnið úr þvagi til þess að fleiri eggfrumur náðust samanborið við FSH unnið úr þvagi.
English: • The 300 IU pen maximum single-dose setting is 300 IU and the smallest single-dose setting is
Icelandic: 300 a.e. lyfjapennans fyrir stakan skammt er 300 a.e. og minnsti staki skammturinn sem hægt er að stilla er 12,5 a.e.
English: Injecting the dose
Icelandic: Skammtinum dælt inn
English: Storing the GONAL-f pre-filled pen.
Icelandic: Auka má skammtinn af GONAL-f, byggt á svörun.
English: GONAL-f contains sodium
Icelandic: GONAL-f inniheldur natríum
English: Merck Europe B.V.
Icelandic: Merck Europe
English: GONAL-f 300 IU/0.50 mL (22 micrograms/0.50 mL) should not be mixed with other medicines in the same injection.
Icelandic: -f 300 a.e./0,50 ml (22 míkrógrömm /0,50 ml) skal ekki blanda saman við önnur lyf í sömu inndælingu.
English: Pack of one pre-filled pen and 12 needles to be used with the pen for administration.
Icelandic: 1 áfylltan lyfjapenna og 12 nálar sem nota á með lyfjapennanum við inndælingu.
English: • GONAL-f in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency.
Icelandic: Mælt er með GONAL-f ásamt gulbúsörvandi hormóni (LH) til örvunar á eggbúsmyndun hjá konum sem hafa mikinn skort á LH og FSH.
English: Clean the skin by wiping with an alcohol swab.
Icelandic: Hreinsaðu húðina með bómullarhnoðra vættum spritti, með hringlaga hreyfingu.
English: 300 IU
Icelandic: 300 a.e.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2 mL/pre-filled syringe
Icelandic: INNIHALD TILGREINT SEM ÞYNGD, RÚMMÁL EÐA FJÖLDI EININGA 2 ml/áfyllt sprauta
English: Excipients: sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, methionine, polysorbate 20, concentrated phosphoric acid and sodium hydroxide.
Icelandic: Hjálparefni: súkrósi, natríumtvívetnisfosfat einhýdrat, tvínatríumfosfat tvíhýdrat, metíónín, pólýsorbat 20, óþynnt fosfórsýra og natríumhýdroxíð.
English: if "0", injectioncomplete ifnot"0",needsecond injection
Icelandic: Ef „0“, inndælingulokið
English: Prescribed Dose
Icelandic: AÐFERÐ VIÐ LYFJAGJÖF
English: Getting your GONAL-f pre-filled pen ready for injection 4.1.
Icelandic: 4. GONAL-f áfyllti lyfjapenninn undirbúinn fyrir inndælingu
English: • The solvent is a clear colourless liquid in a glass vial, each containing 1 mL.
Icelandic: Leysirinn er tær litlaus vökvi í hettuglasi úr gleri, sem hvert inniheldur 1 ml.
English: • The 450 IU pen maximum single-dose setting is 450 IU and the smallest single-dose setting is
Icelandic: Hámarksstilling 450 a.e. lyfjapennans fyrir stakan skammt er 450 a.e. og minnsti staki skammturinn sem hægt er að stilla er 12,5 a.e.
English: Warning: Medicine should not be disposed of via wastewater or household waste.
Icelandic: Ekki má fleygja lyfjum í skólplagnir eða heimilissorp.
English: België/Belgique/Belgien MERCK NV/SA Tél/Tel: +32-2-686 07 11
Icelandic: Tél/Tel: +32-2-686 07 11
English: • Attach the needle for preparation to the empty syringe for injection.
Icelandic: Settu nálina til undirbúnings á tómu inndælingarsprautuna.
English: • Do not use any GONAL-f solution left in the vial after 28 days.
Icelandic: -f lausn sem eftir er í glasinu eftir 28 daga.
English: PHARMACOLOGICAL PROPERTIES
Icelandic: LYFJAFRÆÐILEGIR UPPLÝSINGAR
English: Mild to severe hypersensitivity reactions including anaphylactic reactions and shock Respiratory, thoracic and mediastinal disorders Very rare:
Icelandic: Væg til alvarleg ofnæmisviðbrögð, svo sem bráðaofnæmisviðbrögð og lost Öndunarfæri, brjósthol og miðmæti
English: GONAL-f 900 IU/1.5 mL (66 micrograms/1.5 mL) solution for injection in a pre-filled pen Follitropin alfa
Icelandic: -f 900 a.e./1,5 ml (66 míkrógrömm/1,5 ml) stungulyf, lausn, í áfylltum lyfjapenna Follitrópín alfa
English: Línea de Información: 900 102 964 Tel: +34-91-745 44 00
Icelandic: 900 102 964 Tel:
English: How to use the GONAL-f pre-filled pen
Icelandic: Hvernig nota á GONAL-f áfyllta lyfjapennann
English: • The solvent is a clear colourless liquid in a pre-filled syringe, each containing 2 mL.
Icelandic: Leysirinn er tær litlaus vökvi í áfylltri sprautu, sem hver inniheldur 2 ml.
English: INFORMATION IN BRAILLE gonal-f 450 iu
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI gonal-f 450 a.e.
English: Verify a complete injection.
Icelandic: Athugaðu fyrningardagsetninguá áletrun lyfjapennans.
English: Inspect for particles, and do not use if the solution is not clear.
Icelandic: Athugaðu hvort einhverjar agnir séu og notaðu ekki lausnina sé hún ekki tær.
English: MARKETING AUTHORISATION NUMBER EU/1/95/001/032
Icelandic: MARKAĐLEYFISNÚMER EU/1/95/001/032
English: • When you get the desired response, you will be given a single injection of 250 micrograms of “recombinant hCG” (r-hCG, an hCG made in a laboratory by a special DNA technique), or 5,000 to 10,000 IU of hCG, 24 to 48 hours after your last GONAL-f injection.
Icelandic: Þegar tilætluð svörun næst færð þú staka inndælingu með 250 míkrógrömmum af „raðbrigða hCG“ (r-hCG, hCG sem er framleitt á rannsóknarstofu með sérstakri erfðatækni) eða 5.000 til 10.000 a.e. af hCG, 24 til 48 klst.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1 VIAL AND 1 PRE-FILLED SYRINGE
Icelandic: YTRI UMBÚÐUM ASKJA MEÐ 1 HETTUGLASI OG 1 ÁFYLLTRI SPRAUTU
English: Plunger piston
Icelandic: STOFN OG LEYSI
English: Clinical assessment of GONAL-f indicates that its daily doses, regimens of administration, and treatment monitoring procedures should not be different from those currently used for urinary FSH-containing medicinal products.
Icelandic: -f gefur til kynna að dagskammtar, lyfjagjafir og eftirfylgni meðferðar ættu ekki að vera öðruvísi en það, sem notað er, þegar lyf sem innihalda FSH unnið úr þvagi eru annars vegar.
English: GONAL-f 1050 IU/1.75 mL (77 micrograms/1.75 mL) preparation must not be reconstituted with any other GONAL-f containers.
Icelandic: -f 1050 a.e./1,75 ml (77 míkrógrömm/1,75 ml) má ekki útbúa með öðrum GONAL-f ílátum.
English: What GONAL-f is
Icelandic: Á GONAL-f
English: • The Dose Feedback Window will indicate the missing amount you need to inject using a new pen.
Icelandic: Í skammtaglugganum kemur fram það magn sem þarf að sprauta með nýjum lyfjapenna.
English: • Breast development, acne or weight gain.
Icelandic: Vöxtur brjósta, þrymlabólur eða þyngdaraukning
English: The pen contains 900 IU follitropin alpha.
Icelandic: 5.1. Lyfjapenninn inniheldur 900 a.e. af follitrópíni alfa.
English: • Do not share the pen.
Icelandic: Ekki deila lyfjapennanum með öðrum.
English: • Sacs of fluid within the ovaries (ovarian cysts)
Icelandic: Vökvablöðrur í eggjastokkum (blöðrur á eggjastokkum)
English: • Insert the needle into the solvent vial and push the plunger to expel the air.
Icelandic: Stingdu svo nálinni í hettuglasið með leysinum og ýttu stimplinum til að losna við loft.
English: The solvent for reconstitution is presented in 1 mL pre-filled syringes (Type I glass) with a rubber stopper.
Icelandic: Leysirinn er í 1 ml áfylltum sprautum (tegund 1 gler) með gúmmítappa.
English: GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) preparation must not be reconstituted with any other GONAL-f containers.
Icelandic: GONAL-f 450 a.e./0,75 ml (33 míkrógrömm/0,75 ml) má ekki útbúa með öðrum GONAL-f ílátum.
English: GONAL-f 1050 IU/1.75 mL (77 micrograms/1.75 mL) must be reconstituted with the 2 mL solvent provided before use.
Icelandic: Útbúa skal fullbúna lausn af GONAL-f 1050 a.e./1,75 ml (77 míkrógrömm/1,75 ml) með meðfylgjandi 2 ml af leysi fyrir notkun.
English: Sodium dihydrogen phosphate monohydrate Disodium phosphate dihydrate Phosphoric acid, concentrated Sodium hydroxide
Icelandic: Natríumtvíhýdrógenfosfat einhýdrat Tvínatríumfosfat tvíhýdrat Fosfórsýra, óþynnt Natríumhýdroxíð
English: Verify once more that the Dose Feedback Window displays the correct dose.
Icelandic: 6.3. Gakktu aftur úr skugga um það að skammtaglugginn sýni réttan skammt.
English: GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) preparation is not to be mixed with other GONAL-f containers within the same vial or syringe.
Icelandic: GONAL-f 450 a.e./0,75 ml (33 míkrógrömm /0,75 ml) lyfi skal ekki blanda saman við önnur GONAL-f ílát í sama hettuglasi eða sprautu.
English: GONAL-f 300 IU/0.50 mL (22 micrograms/0.50 mL) preparation must not be reconstituted with any other GONAL-f containers.
Icelandic: -f 300 a.e./0,50 ml (22 míkrógrömm/0,50 ml) má ekki útbúa með öðrum GONAL-f ílátum.
English: • Allergic reactions such as rash, red skin, hives, swelling of your face with difficulty in breathing may occur.
Icelandic: Ofnæmisviðbrögð, svo sem útbrot, húðroði, kláði, þroti í andliti ásamt öndunarerfiðleikum,
English: Excipients: sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, concentrated phosphoric acid and sodium hydroxide.
Icelandic: Hjálparefni: súkrósi, natríumtvívetnisfosfat einhýdrat, tvínatríumfosfat tvíhýdrat, óþynnt fosfórsýra og natríumhýdroxíð.
English: GONAL-f 300 IU/0.50 mL (22 micrograms/0.50 mL) must be reconstituted with the 0.75 mL solvent provided before use.
Icelandic: Útbúa skal fullbúna lausn af GONAL-f 300 a.e./0,50 ml (22 míkrógrömm/0,50 ml) með meðfylgjandi 0,75 ml af leysi fyrir notkun.
English: • GONAL-f is presented as a clear, colourless liquid for injection in a pre-filled pen.
Icelandic: GONAL-f kemur fyrir sem tært, litlaust stungulyf, vökvi, í áfylltum lyfjapenna.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 mL/pre-filled syringe
Icelandic: INNIHALD TILGREINT SEM ÞYNGD, RÚMMÁL EÐA FJÖLDI EININGA 1 ml/áfyllt sprauta
English: • GONAL-f is supplied in packs of 1 vial of powder with 1 vial of solvent.
Icelandic: GONAL-f er fáanlegt í pakkningum með 1 hettuglasi af stungulyfsstofni og 1 hettuglasi með leysi.
English: • The solvent is a clear colourless liquid in a pre-filled syringe, each containing 1 mL.
Icelandic: Leysirinn er tær litlaus vökvi í áfylltri sprautu, sem hver inniheldur 1 ml.
English: Miscarriage
Icelandic: Skammtastillir
English: Each multidose vial contains 87 micrograms of follitropin alfa* (equivalent to 1200 IU), in order to deliver 77 micrograms (equivalent to 1050 IU) in 1.75 mL.
Icelandic: Hvert fjölskammta hettuglas inniheldur 87 míkrógrömm af follitrópíni alfa*(samsvarandi 1.200 a.e), til að gefa 77 míkrógrömm (samsvarandi 1.050 a.e.) í 1,75 ml. Hver ml af blandaðri lausn inniheldur 600 a.e. * raðbrigða FSH manna (recombinant human follicle stimulating hormone (r-hFSH)) framleitt með erfðatæknilegum aðferðum í eggjafrumum kínverskra hamstra (CHO).
English: GONAL-f 1050 IU/1.75 mL (77 micrograms/1.75 mL) preparation is not to be mixed with other GONAL-f containers within the same vial or syringe.
Icelandic: -f 1050 a.e./1,75 ml (77 míkrógrömm /1,75 ml) lyfi skal ekki blanda saman við önnur GONAL-f ílát í sama hettuglasi eða sprautu.
English: • The 900 IU pen maximum single-dose setting is 450 IU and the smallest single-dose setting is
Icelandic: 900 a.e. lyfjapennans fyrir stakan skammt er 450 a.e. og minnsti staki skammturinn sem hægt er að stilla er 12,5 a.e.
English: The solvent for reconstitution is presented in 2 mL pre-filled syringes (Type I glass) with a rubber stopper.
Icelandic: Leysirinn er í 2 ml áfylltum sprautum (tegund 1 gler) með gúmmítappa.
English: When an optimal response is obtained, a single injection of 250 micrograms recombinant human choriogonadotropin alfa (r-hCG) or 5,000 IU, up to 10,000 IU hCG should be administered 24-48 hours after the last GONAL-f injection.
Icelandic: Þegar besta svörun hefur náðst, skal gefa staka inndælingu með 250 míkróg af raðbrigða kóríogónadótrópíni alfa (r-hCG) eða frá 5.000 a.e. til allt að 10.000 a.e. af hCG 24-48 klst.
English: • primary ovarian failure
Icelandic: • bilun í eggjastokkum
English: Adherence to recommended GONAL-f dose and regimen of administration, and careful monitoring of therapy will minimise the incidence of such events.
Icelandic: Hægt er að minnka þessa áhættu með góðu eftirliti og með því að halda sig við ráðlagða skammta við GONAL-f meðferð og fylgja ráðleggingum um notkun.
English: EU/1/95/001/025 1 vial of powder for solution for injection.
Icelandic: EU/1/95/001/025/ 1 hettuglas með stungulyfsstofn, lausn.
English: 1 multidose pre-filled pen
Icelandic: 1 ml/ áfyllt sprauta
English: MARKETING AUTHORISATION NUMBER EU/1/95/001/021
Icelandic: MARKAĐLEYFISNÚMER EU/1/95/001/021
English: The medicinal product is supplied as a pack of 1 vial of powder with 1 pre-filled syringe of solvent for reconstitution and 15 disposable syringes for administration graduated in FSH units.
Icelandic: GONAL-f er fáanlegt í pakkningum með 1 hettuglasi með stungulyfsstofni, 1 áfylltri sprautu með leysi og 15 einnota sprautum til lyfjagjafar, kvörðuðum í alþjóðlegum einingum (a.e. FSH).
English: Date:
Icelandic: Dags:
English: 1 pre-filled syringe of 1 mL solvent.
Icelandic: 1 áfyllt sprauta með 1 ml af leysi.
English: • Take your pre-filled syringe, insert the needle into the powder vial and slowly inject all the solvent into the vial containing the powder.
Icelandic: Taktu áfylltu sprautuna með leysinum, stingdu nálinni í hettuglasið með stofninum og sprautaðu varlega öllum leysinum ofan í hettuglasið með stofninum.
English: • After reconstitution, there are 1,050 IU (77 micrograms) of follitropin alfa in 1.75 mL solution,
Icelandic: Eftir blöndun eru 1.050 a.e. (77 míkrógrömm) af follitrópíni alfa í 1,75 ml lausn, sem táknar að það eru 600 a.e. (44 míkrógrömm) í hverjum millilítra af lausn.
English: How to use your GONAL-f pre-filled pen Treatment Diary
Icelandic: Hvernig nota á meðferðardagbók fyrir GONAL-f áfylltan lyfjapenna
English: • When needed, inject yourself using a second pen, dialing your remaining dose written in the
Icelandic: Þegar á þarf að halda skaltu sprauta þig með öðrum lyfjapenna og velja skammtinn sem eftir var eins og kemur fram í kaflanum „Magn eftir inndælingu“ (8).
English: 5 vials of powder for solution for injection.
Icelandic: 5 hettuglös með stungulyfsstofn, lausn.
English: Merck Serono SIA Tel: +371 67152500
Icelandic: Tel: +371 67152500
English: INFORMATION IN BRAILLE gonal-f 300 iu/0.5 mL
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI gonal-f 300 a.e./0,5 ml.
English: For immediate and single use following first opening and reconstitution.
Icelandic: Fullbúna einnota lausn skal nota strax og aðeins einu sinni.
English: • Remove the protective caps from the powder vial and from the pre-filled syringe.
Icelandic: Fjarlægðu hlífðarlokið af hettuglasinu með stofninum og af áfylltu sprautunni.
English: INFORMATION IN BRAILLE gonal-f 450 iu/0.75 mL
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI gonal-f 450 a.e./0,75 ml.
English: Verify you have given a complete injection.
Icelandic: 7.1 Athugaðu hvort öllum skammtinum hefur verið dælt inn
English: GONAL-f is intended for subcutaneous use.
Icelandic: GONAL-f er ætlað til notkunar undir húð.
English: GONAL-f 300 IU/0.50 mL (22 micrograms/0.50 mL) preparation is not to be mixed with other GONAL-f containers within the same vial or syringe.
Icelandic: -f 300 a.e./0,50 ml (22 míkrógrömm /0,50 ml) lyfi skal ekki blanda saman við önnur GONAL-f ílát í sama hettuglasi eða sprautu.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/95/001/032 1 vial of powder for solution for injection.
Icelandic: MARKAÐSLEYFISNÚMER EU/1/95/001/032 1 hettuglas af stungulyfsstofn, lausn.
English: Gynaecomastia, Varicocele
Icelandic: Stækkuð karlmannsbrjóst, kólfsæðavíkkun
English: Vascular disorders
Icelandic: DAGSETNING BLÖNDUNAR
English: • Once opened, it may be stored for a maximum of 28 days outside of the fridge (at or below
Icelandic: Þegar umbúðir hafa verið rofnar má geyma lyfið í hámark 28 daga utan kælis (við 25°C eða lægra hitastig).
English: GONAL-f Pre-filled pen 900 IU/1.5 mL
Icelandic: Áfylltur lyfjapenni 900 a.e./1,5 ml
English: DATE OF RECONSTITUTION
Icelandic: FYRNINGARDAGSETNING
English: • Lower abdominal pain together with nausea or vomiting may be the symptoms of Ovarian Hyper-Stimulation Syndrome (OHSS).
Icelandic: Verkir í neðri hluta kviðar, auk ógleði eða uppkasta, geta verið einkenni oförvunarheilkennis eggjastokka.
English: The medicinal product is supplied as a pack of 1 vial of powder with 1 pre-filled syringe of solvent for reconstitution and 6 disposable syringes for administration graduated in FSH units.
Icelandic: GONAL-f er fáanlegt í pakkningum með 1 hettuglasi með stungulyfsstofni, 1 áfylltri sprautu með leysi og 6 einnota sprautum til lyfjagjafar, kvörðuðum í alþjóðlegum einingum (a.e. FSH).
English: • The pre-filled syringe containing the solvent (the clear liquid)
Icelandic: • áfyllta sprautan með leysinum (tær vökvi)
English: GONAL-f Pre-filled pen 300 IU/0.5 mL
Icelandic: Áfylltur lyfjapenni 300 a.e./0,5 ml
English: if "0", injectioncomplete if not "0", need second injection
Icelandic: Ef ekki „0“þarf aðra inndælingu
English: 300IU
Icelandic: 300a.e.
English: • Turn the vial upside down and gently draw up all the solvent.
Icelandic: á hvolf og dragðu varlega upp allan leysinn.
English: 1 vial of 1 mL solvent.
Icelandic: 1 hettuglas með 1 ml af leysi.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for use with GONAL-f 1050 IU/1.75 mL Water for injections, benzyl alcohol 0.9%
Icelandic: -f 1050 a.e./1,75 ml Vatn fyrir stungulyf, bensýlalkóhól 0,9%
English: Porphyria
Icelandic: Innsiglisflipi
English: PHARMACEUTICAL FORM AND CONTENTS 1 vial of powder for solution for injection.
Icelandic: LYFJAFORM OG INNIHALD 1 hettuglas af stungulyfsstofn, lausn.
English: Solvent for solution for injection
Icelandic: Fylgiseðill: upplýsingar fyrir notanda lyfsins
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/1/95/001/034 solution for injection in pre-filled pen.
Icelandic: MARKAÐSLEYFISNÚMER EU/1/95/001/034 Stungulyf, lausn, í áfylltum lyfjapenna.
English: How to use the GONAL-f pre-filled pen How to use your GONAL-f pre-filled pen Treatment diary Before you start using your GONAL-f pre-filled pen Getting your GONAL-f pre-filled pen ready for injection Setting the dose prescribed by your doctor Injecting the dose
Icelandic: Áður en þú byrjar að nota GONAL-f áfyllta lyfjapennann GONAL-f áfyllti lyfjapenninn undirbúinn fyrir inndælingu
English: The medicinal product is supplied as a pack of 1 vial of powder with 1 pre-filled syringe of solvent for reconstitution and 4 disposable syringes for administration graduated in FSH units.
Icelandic: GONAL-f er fáanlegt í pakkningum með 1 hettuglasi með stungulyfsstofni, 1 áfylltri sprautu með leysi og 4 einnota sprautum til lyfjagjafar, kvörðuðum í alþjóðlegum einingum (a.e. FSH).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/95/001/035 solution for injection in pre-filled pen.
Icelandic: MARKAÐSLEYFISNÚMER EU/1/95/001/035 Stungulyf, lausn, í áfylltum lyfjapenna.