FrancophonIA/ELRC3.0 huggingface dataset:
English: • The needle should be facing down.
Icelandic: Nálin á að snúa niður á við.
English: • Each 0.01 mL is shown as a smaller line.
Icelandic: Hver 0,01 ml er sýndur sem númer með mjórri línu.
English: • feeling sleepy or confused
Icelandic: • aukin syfja eða rugl
English: - Tapering the dose over a two-week period is recommended in conjunction with a low fat diet. - Patients should be monitored during tapering.
Icelandic: - Ráðlagt er að minnka skammtinn á tveggja vikna tímabili í tengslum við fitusnautt mataræði.
English: After dissolving the vial contents in 0.6 millilitres of water for injections, each millilitre contains 5 milligrams of metreleptin.
Icelandic: Eftir að innihald hettuglassins hefur verið leyst upp í 0,6 ml af vatni fyrir stungulyf, inniheldur hver millilítri 5 milligrömm af metreleptíni.
English: It is a white powder supplied in a glass vial with a rubber stopper and an aluminium seal with a blue plastic flip-off cap.
Icelandic: Það er hvítt duft í hettuglasi úr gleri með gúmmítappa og álinnsigli með bláu smelluloki úr plasti.
English: • going to the toilet to pass urine more often
Icelandic: • auknar salernisferðir til að kasta þvagi
English: - The benefits and risks of Myalepta should be carefully considered in patients with acquired LD and/or those with significant haematologic abnormalities (including leukopenia, neutropenia, bone marrow abnormalities, lymphoma and/or lymphadenopathy).
Icelandic: Myalepta hjá sjúklingum með áunninn fitukyrking og/eða hjá þeim sem eru með veruleg frávik í blóði (þ.m.t. hvítfrumnafæð, daufkyrningafæð, frávik í beinmerg, eitilæxli og/eða eitlakvilla).
English: • pain below the ribs like heartburn or indigestion
Icelandic: verkur undir rifbeinum sem líkist brjóstsviða eða meltingartruflunum
English: o The vials may remain almost completely filled with product after withdrawal of the required dose.
Icelandic: Hettuglösin geta verið næstum því full af lyfi þó búið sé að draga upp ávísaðan skammt.
English: Anaphylactic reactions may follow immediately after administration of the medicine.
Icelandic: Bráðaofnæmisviðbrögð geta komið fram strax í kjölfar lyfjagjafar.
English: Do not over-tighten the needle.
Icelandic: Ekki herða nálina um of.
English: 0.168 mL 0.16 mL
Icelandic: 0,168 ml
English: 9) With 2.2 mL of water for injection in the syringe, remove the syringe from the vial or ampoule.
Icelandic: Þegar 2,2 ml af vatni fyrir stungulyf eru í sprautunni, skaltu fjarlægja sprautuna úr hettuglasinu eða lykjunni.
English: 0.204 mL 0.20 mL
Icelandic: 0,204 ml
English: Attach the needle to the 1 mL syringe.
Icelandic: Festu nálina við 1 ml sprautuna.
English: • with confirmed congenital generalised LD (Berardinelli-Seip syndrome) or acquired generalised LD (Lawrence syndrome) in adults and children 2 years of age and above
Icelandic: Fullorðnir og börn, 2 ára og eldri, með staðfestan meðfæddan útbreiddan fitukyrking (generalised lipodystrophy) (Berardinelli-Seip heilkenni) eða áunninn útbreiddan fitukyrking (Lawrence-heilkenni)
English: ‘Unit' measurement volume in 0.3 mL
Icelandic: Mælirúmmálið „einingar“ í 0,3 ml sprautu til inndælingar
English: • Hold the ampoule so that the top is facing up.
Icelandic: Haltu lykjunni þannig að mjórri endinn snúi upp.
English: If you stop using Myalepta
Icelandic: Ef hætt er að nota Myalepta
English: Hepatic Impairment
Icelandic: Altækur fitukyrkingur
English: After reconstitution with 0.6 mL water for injections (see section 6.6), each mL contains 5 mg of metreleptin.
Icelandic: Eftir blöndun með 0,6 ml af vatni fyrir stungulyf (sjá kafla 6.6), inniheldur hver ml 5 mg af metreleptíni.
English: Each vial contains 3 mg of metreleptin After reconstitution, each mL contains 5 mg of metreleptin (5 mg/mL)
Icelandic: Eftir blöndun inniheldur hver ml 5 mg af metreleptíni (5 mg/ml)
English: It is a white powder supplied in a glass vial with a rubber stopper and an aluminium seal with a white plastic flip-off cap.
Icelandic: Það er hvítt duft í hettuglasi úr gleri með gúmmítappa og álinnsigli með hvítu smelluloki úr plasti.
English: 9) With 1.1 mL of water for injection in the syringe, remove the syringe from the vial or ampoule.
Icelandic: Þegar 1,1 ml af vatni fyrir stungulyf eru í sprautunni, skaltu fjarlægja sprautuna úr hettuglasinu eða lykjunni.
English: • Each vial contains 5.8 milligrams of metreleptin.
Icelandic: Hvert hettuglas inniheldur 5,8 mg af metreleptíni*.
English: • a glass vial of Myalepta powder
Icelandic: glerhettuglas með Myalepta dufti
English: Cough, Dyspnoea Pleural effusion
Icelandic: YTRI UMBÚÐUM YTRI ASKJA
English: o Serious and severe infections secondary to the appearance of NAb may occur.
Icelandic: o Alvarlegar og verulegar sýkingar sem koma í kjölfar myndunar á hlutleysandi mótefnum geta komið fram.
English: It is a white powder supplied in a glass vial with a rubber stopper and an aluminium seal with a red plastic flip-off cap.
Icelandic: Það er hvítt duft í hettuglasi úr gleri með gúmmítappa og álinnsigli með rauðu smelluloki úr plasti.
English: There is a risk of hypoglycaemia in patients treated with Myalepta who are on anti-diabetic medicinal products, in particular insulin or insulin secretagogues (e.g. sulphonylureas).
Icelandic: Hætta er á blóðsykursfalli hjá sjúklingum sem fá meðferð með Myalepta og eru á öðrum sykursýkislyfjum, einkum insúlíni eða seytingarörvum insúlíns (t.d. súlfónýlúrealyfjum).
English: 0.144 mL 0.14 mL
Icelandic: 0,144 ml
English: INSTRUCTIONS ON USE
Icelandic: Viðbótarupplýsingar er varða þjálfun
English: Table 2 Dose calculation Weight and gender Starting dose calculation
Icelandic: Tafla 2 Skammtaútreikningur Þyngd og kyn
English: • With the syringe still inserted into the glass vial or plastic ampoule, tap the side of the syringe to move the air pocket/air bubbles to the top of the syringe.
Icelandic: Bankaðu létt á hlið sprautunnar til að færa loftvasann/loftbólurnar efst í sprautuna á meðan sprautan er enn í glerhettuglasinu eða plastlykjunni.
English: Glass vial of water for injection
Icelandic: Vatn fyrir stungulyf í glerlykju
English: 5) Withdraw 1.1 mL of water for injection into the 3 mL syringe.
Icelandic: 1,1 ml af vatni fyrir stungulyf upp í 3 ml sprautuna.
English: 0.252 mL 0.25 mL
Icelandic: 0,252 ml
English: • 15% reduction in triglycerides (TGs)
Icelandic: 15% lækkun þríglýseríða
English: Treatment should be initiated and monitored by a healthcare professional experienced in the diagnosis and management of metabolic disorders.
Icelandic: Læknir með reynslu í greiningu og meðhöndlun efnaskiptatruflana skal hefja meðferðina og hafa eftirlit með henni.
English: Type I glass vial (3 mL) with a chlorobutyl rubber stopper and an aluminium seal/red plastic flip-off cap.
Icelandic: Hettuglas úr gleri af gerð I (3 ml) með klóróbútýl gúmmítappa og álinnsigli/rauðu smelluloki úr plasti.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Myalepta therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Icelandic: Vega þarf og meta kosti brjóstagjafar fyrir barnið og ávinning meðferðar fyrir konuna og ákveða á grundvelli matsins hvort hætta eigi brjóstagjöf eða hætta/stöðva tímabundið meðferð með Myalepta.
English: 0.132 mL 0.13 mL
Icelandic: 0,132 ml
English: • Do not attach the needle to the syringe.
Icelandic: Ekki festa sprautuna við nálina.
English: Pull the plunger down carefully • Pull it down until the top rim of the plunger lines up with the black 1.1 mL line.
Icelandic: Dragðu stimpilinn varlega niður. • Dragðu hann niður þar til efri brún stimplisins nemur við svörtu 1,1 ml línuna.
English: • fainting or feeling dizzy
Icelandic: • ógleði eða uppköst
English: 0.288 mL 0.28 mL
Icelandic: 0,288 ml
English: Metabolism and nutrition disorders Hypoglycaemia Decreased appetite Diabetes mellitus, Hyperphagia, Insulin resistance
Icelandic: Blóðsykursfall Minnkuð matarlyst Sykursýki, matgræðgi, insúlínþol
English: Pull the plunger down carefully • Pull it down until the top rim of the plunger lines up with the black 2.2 mL line.
Icelandic: Dragðu stimpilinn varlega niður. • Dragðu hann niður þar til efri brún stimplisins nemur við svörtu 2,2 ml línuna.
English: 21 gauge 40 mm needle Myalepta 11.3 mg powder for solution for injection 3.0 mL
Icelandic: Myalepta 11,3 mg stungulyfsstofn, lausn 3,0 ml
English: Endogenous leptin is present in human milk.
Icelandic: Innrænt leptín er til staðar í brjóstamjólk.
English: What you need to know before you use Myalepta 3.
Icelandic: Áður en byrjað er að nota Myalepta 3. Hvernig nota á Myalepta 4. Hugsanlegar aukaverkanir
English: Myalepta 11.3 mg powder for solution for injection metreleptin
Icelandic: Myalepta 11,3 mg stungulyfsstofn, lausn metreleptín
English: Pull the plunger down carefully • Pull it down until the top rim of the plunger lines up with the black 0.6 mL line.
Icelandic: Dragðu stimpilinn varlega niður. • Dragðu hann niður þar til efri brún stimplisins nemur við svörtu 0,6 ml línuna.
English: Following single subcutaneous doses of 0.01 to 0.3 mg/kg metreleptin in healthy adult subjects, the half-life was 3.8 to 4.7 hours.
Icelandic: eftir gjöf á stökum skömmtum á bilinu 0,1 til 0,3 mg/kg hjá heilbrigðum fullorðnum einstaklingum.
English: 0.300 mL 0.30 mL *Note: Initial and dose increments should be rounded down to the nearest 0.01 mL
Icelandic: Upphafs- og skammtahækkanir skal námunda niður í næsta 0,01 ml
English: 0.276 mL 0.27 mL
Icelandic: 0,276 ml
English: Take your time to carefully prepare and inject your medicine, which when including the period of the vial warming up after being taken out of the fridge, can be approximately 20 minutes in total.
Icelandic: 20 mínútur í heildina þegar tíminn sem það tekur hettuglasið að hitna eftir að það hefur verið tekið úr kæli er meðtalinn.
English: Rounded amount of solution
Icelandic: Námundað magn af lausn
English: 0.180 mL 0.18 mL
Icelandic: 0,180 ml
English: 0.192 mL 0.19 mL
Icelandic: 0,192 ml
English: 0.108 mL 0.10 mL
Icelandic: 0,108 ml
English: Hypoglycaemia with concomitant use of insulin and other anti-diabetics
Icelandic: Blóðsykursfall með samhliða notkun insúlíns og annarra sykursýkislyfja
English: • diarrhoea
Icelandic: • þokusýn
English: Amount of mixed Myalepta solution
Icelandic: Myalepta lausnar
English: • Without the needle attached, insert the 3 mL syringe tip into the top of the plastic ampoule as far as possible.
Icelandic: Stingdu stút 3 ml sprautunnar eins langt og hægt er inn í op plastlykjunnar, án þess að festa nálina við.
English: Myalepta 5.8 mg powder for solution for injection metreleptin
Icelandic: Myalepta 5,8 mg stungulyfsstofn, lausn metreleptín
English: 0.264 mL 0.26 mL
Icelandic: 0,264 ml
English: 21 gauge 40 mm needle Myalepta 5.8 mg powder for solution for injection 3.0 mL
Icelandic: Myalepta 5,8 mg stungulyfsstofn, lausn 3,0 ml
English: Generalised LD
Icelandic: T-frumu eitilæxli
English: • Without the needle attached, insert the 1 mL syringe tip into the top of the plastic ampoule as far as possible.
Icelandic: Stingdu stút 1 ml sprautunnar eins langt og hægt er inn í op plastlykjunnar, án þess að festa nálina við.
English: Myalepta 11.3 mg powder for solution for injection Type I glass vial (5 mL) with a bromobutyl rubber stopper and an aluminium seal/white plastic flip-off cap.
Icelandic: Hettuglas úr gleri af gerð I (5 ml) með brómóbútýl gúmmítappa og álinnsigli/hvítu smelluloki úr plasti.
English: Myalepta 3 mg powder for solution for injection metreleptin
Icelandic: Myalepta 3 mg stungulyfsstofn, lausn metreleptín
English: • Each vial contains 3 milligrams of metreleptin.
Icelandic: Hvert hettuglas inniheldur 3 mg af metreleptíni*.
English: o Hypoglycaemia with concomitant use of insulin and other antidiabetics may occur.
Icelandic: o Blóðsykursfall getur komið fram við samhliða notkun insúlíns og annarra sykursýkislyfja.
English: In generalised LD patients, the overall incidence of adverse reactions was similar regardless of age.
Icelandic: Hjá sjúklingum með útbreiddan fitukyrking var heildartíðni aukaverkana svipuð án tillits til aldurs.
English: • Do not move the plunger.
Icelandic: Ekki hreyfa stimplinn.
English: The reconstituted solution should be injected into the abdomen, thigh or upper arm tissue.
Icelandic: Dæla skal blönduðu lausninni í kvið, læri eða upphandleggsvöðva.
English: 0.240 mL 0.24 mL
Icelandic: 0,240 ml
English: Units.
Icelandic: öllu lyfinu.
English: 6) No matter whether you have withdrawn water for injection from a vial or ampoule, you must check for air pockets or air bubbles in your 1 mL syringe.
Icelandic: Þú verður að athuga hvort þú sérð loftvasa eða loftbólur í 1 ml sprautunni, sama hvort þú hafir dregið vatn fyrir stungulyf upp úr hettuglasi eða lykju.
English: Excipients
Icelandic: Eitilæxli
English: Adverse reactions are classified by MedDRA System Organ Class and absolute frequency in Table 7.
Icelandic: Aukaverkanirnar eru flokkaðar eftir MedDRA líffærakerfi og heildartíðni í töflu
English: Myalepta 5.8 mg powder for injection metreleptin
Icelandic: Myalepta 5,8 mg stungulyfsstofn metreleptín
English: 1.1 millilitres of water for injections, each millilitre contains 5 milligrams of metreleptin.
Icelandic: Eftir að innihald hettuglassins hefur verið leyst upp í 1,1 ml af vatni fyrir stungulyf, inniheldur hver millilítri 5 milligrömm af metreleptín.
English: 0.216 mL 0.21 mL
Icelandic: 0,216 ml
English: Most of these patients (13 of 16) were able to stop insulin use within the first year of metreleptin.
Icelandic: Flestir þessara sjúklinga (13 af 16)
English: In patients with serious and severe infections, continuation of metreleptin should be at the discretion of the prescriber.
Icelandic: Áframhaldandi meðferð með metreleptíni hjá sjúklingum með alvarlegar og verulegar sýkingar skal fara fram samkvæmt ákvörðun læknisins sem ávísaði lyfinu.
English: Myalepta 11.3 mg powder for injection metreleptin
Icelandic: Myalepta 11,3 mg stungulyfsstofn metreleptín
English: Males and females ≤ 40 kg 0.06 mg/kg (0.012 mL/kg)
Icelandic: 0,06 mg/kg (0,012 ml/kg)
English: 31 gauge 8 mm needle
Icelandic: Sporvídd 31 8 mm nál
English: 6) No matter whether you have withdrawn water for injection from a vial or ampoule, you must check for air pockets or air bubbles in your 3 mL syringe.
Icelandic: Þú verður að athuga hvort þú sérð loftvasa eða loftbólur í 3 ml sprautunni, sama hvort þú hafir dregið vatn fyrir stungulyf upp úr hettuglasi eða lykju.
English: Myalepta 3 mg powder for injection metreleptin
Icelandic: Myalepta 3 mg stungulyfsstofn metreleptín
English: Myalepta 5.8 mg powder for solution for injection
Icelandic: Myalepta 5,8 mg stungulyfsstofn, lausn
English: • who have generalised lipodystrophy (the whole of your body does not have enough fatty tissue) It is used, when other treatments have been ineffective, in adults, and adolescents 12 years or over:
Icelandic: sem eru með útbreiddan fitukyrking (ekki er nægilegur fituvefur í öllum líkamanum)
English: 2.2 millilitres of water for injections, each millilitre contains 5 milligrams of metreleptin.
Icelandic: Eftir að innihald hettuglassins hefur verið leyst upp í 2,2 ml af vatni fyrir stungulyf, inniheldur hver millilítri 5 milligrömm af metreleptín.
English: • Insert the 3 mL syringe needle into the vial, through the rubber seal.
Icelandic: Stingdu nálinni á 3 ml sprautunni inn í hettuglasið í gegnum gúmmíinnsiglið.
English: With the syringe still in the ampoule, pull the plunger down carefully, • Pull down until the top rim of the plunger lines up with the black 1.1 mL line.
Icelandic: Dragðu stimpilinn varlega niður á meðan sprautunni er haldið í lykjunni. • Dragðu niður þar til efri brún stimplisins nemur við svörtu 1,1 ml línuna.
English: • Do not remove the needle from the vial.
Icelandic: Ekki fjarlægja nálina úr hettuglasinu.
English: With the syringe still in the ampoule, pull the plunger down carefully, • Pull down until the top rim of the plunger lines up with the black 2.2 mL line.
Icelandic: Dragðu stimpilinn varlega niður á meðan sprautunni er haldið í lykjunni. • Dragðu niður þar til efri brún stimplisins nemur við svörtu 2,2 ml línuna.
English: • swelling and reddening of the skin, hives
Icelandic: bólga og roði í húð, ofsakláði
English: Fertility
Icelandic: Glútamínsýra
English: • 1 U is the same as 0.01 mL.
Icelandic: er það sama og 0,01 ml.
English: Myalepta 11.3 mg powder for solution for injection.
Icelandic: Myalepta 11,3 mg stungulyfsstofn, lausn
English: Fatigue, Injection site bruising, Injection site erythema, Injection site reaction
Icelandic: Þreyta, mar á stungustað, roði á stungustað, viðbrögð á stungustað
English: With the syringe still in the ampoule, pull the plunger down carefully, • Pull down until the top rim of the plunger lines up with the black 0.6 mL line.
Icelandic: Dragðu stimpilinn varlega niður á meðan sprautunni er haldið í lykjunni. • Dragðu niður þar til efri brún stimplisins nemur við svörtu 0,6 ml línuna.
English: Peak serum leptin (endogenous leptin and metreleptin) concentration (Cmax) occurred approximately 4.0 hours after subcutaneous administration of single doses ranging from 0.1 to 0.3 mg/kg in healthy adult subjects.
Icelandic: Hámarksþéttni (Cmax) leptíns í sermi (innrænt leptín og metreleptín) kom fram um það bil 4,0 klst.
English: Myalepta 3 mg powder for solution for injection Using a 1 mL syringe with a 21-gauge or smaller diameter needle, withdraw 0.6 mL of water for injection.
Icelandic: Dragðu upp 0,6 ml af vatni fyrir stungulyf með því að nota 1 ml sprautu með nál sem er af sporvídd 21 eða fínni.
English: Reading the syringe
Icelandic: Aflestur sprautunnar
English: Table 3 Required syringe for Myalepta reconstitution with water for injection Syringe
Icelandic: Tafla 4 Sprauta sem þarf fyrir gjöf á hverjum skammti af Myalepta Sprauta
English: 0.120 mL 0.12 mL
Icelandic: 0,120 ml
English: Myalepta 3 mg powder for solution for injection
Icelandic: Myalepta 3 mg stungulyfsstofn, lausn
English: Myalepta 11.3 mg powder for solution for injection Using a 3 mL syringe with a 21-gauge or smaller diameter needle, withdraw 2.2 mL of water for injection.
Icelandic: Dragðu upp 1,1 ml af vatni fyrir stungulyf með því að nota 3 ml sprautu með nál sem er af sporvídd 21 eða fínni.
English: Important: Myalepta must be injected under the skin (‘subcutaneous').
Icelandic: Sprauta þarf Myalepta undir húðina.
English: Arthralgia, Myalgia
Icelandic: Hósti, mæði, fleiðruvökvi
English: • Insert the 1 mL syringe needle into the vial, through the rubber seal.
Icelandic: Stingdu nálinni á 1 ml sprautunni inn í hettuglasið í gegnum gúmmíinnsiglið.
English: Renal Impairment
Icelandic: Hlutleysandi mótefni
English: What is in this leaflet
Icelandic: Ef sprautan þín lítur
English: 0.228 mL 0.22 mL
Icelandic: 0,228 ml
English: • muscle pain (‘myalgia')
Icelandic: vöðvaverkir („vöðvaþrautir“)
English: 19) Keeping the needle inside the vial, pull the plunger down.
Icelandic: 19) Dragðu stimpilinn niður á meðan nálinni er haldið inni í hettuglasinu.
English: Reproductive system and breast disorders
Icelandic: Sporvídd og lengd nálar
English: Neutralising antibodies
Icelandic: Flokkun eftir líffærum
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Icelandic: Myalepta og pakkningastærðir
English: Line up the top rim of the plunger with the line for the prescribed dose.
Icelandic: Láttu efri brún stimplisins nema við línuna fyrir ávísaða skammtinn.
English: The adverse reactions reported in generalised LD and this subgroup of partial LD patients are listed in Table 7.
Icelandic: Aukaverkanirnar sem tilkynnt var um hjá sjúklingum með útbreiddan fitukyrking og í þessum undirhópi með ágengan fitukyrking eru taldar upp í töflu
English: • cold hands or feet
Icelandic: kaldar hendur eða fætur
English: Eighteen patients completed the study.
Icelandic: Átján sjúklingar luku rannsókninni.
English: 6MWT (meters)
Icelandic: 6MWT (metrar)
English: Some of these reactions may be severe.
Icelandic: Sumar þessara aukaverkana geta verið alvarlegar.
English: ATC code: A16AB05.
Icelandic: A16AB05.
English: Not known (frequency cannot be estimated from the available data)
Icelandic: Tíðni ekki þekkt (ekki er hægt að áætla tíðni út frá fyrirliggjandi gögnum)
English: • bluish color of the skin (due to lower levels of oxygen in the blood)
Icelandic: bláleit húð (vegna of lítils súrefnis í blóðinu)
English: Investigations blood pressure increased
Icelandic: Rannsóknaniðurstöður hækkaður blóðþrýstingur
English: Cmax showed an increase over time.
Icelandic: Cmax jókst með tímanum.
English: AUC∞ (h•U/ml) 0.930 ± 0.214 CL (ml/min/kg) 1.96 ± 0.495 Vz (l/kg)
Icelandic: AUC (h•U/ml) 0,930 ± 0,214 CL (ml/mín/kg) 1,96 ± 0,495 Vz (l/kg)
English: Aldurazyme was well tolerated at both dosages.
Icelandic: Aldurazyme þoldist vel í báðum skammtastærðum.
English: MedDRA Preferred term
Icelandic: MedDRA heiti (preferred term)
English: The number of these reactions decreased the longer that patients were on Aldurazyme.
Icelandic: Fjöldi þessara aukaverkana minnkaði því lengur sem sjúklingar notuðu Aldurazyme.
English: The mean urinary GAG level declined by 50% at Week 13 and was reduced by 61% at the end of the study.
Icelandic: Meðalstyrkur GAG í þvagi hafði lækkað um 50% í 13. viku og hafði lækkað um 61% í lok rannsóknarinnar.
English: As a result, these substances do not get broken down and processed by the body as they should.
Icelandic: Þar af leiðandi brotna þessi efni ekki niður í líkamanum og hann vinnur ekki úr þeim eins og hann ætti að gera.
English: Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom.
Icelandic: Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, Bretland.
English: Aldurazyme should not be mixed with other medicinal products in the same infusion.
Icelandic: Ekki skal blanda Aldurazyme við önnur lyf í sama innrennsli.
English: Three clinical trials were performed with Aldurazyme to assess its efficacy and safety.
Icelandic: Þrjár klínískar rannsóknir voru gerðar á Aldurazyme til að meta öryggi þess og verkun.
English: Date of latest renewal: 10 June 2008
Icelandic: 10. júní 2003 Dagsetning síðustu endurnýjunar:
English: Aldurazyme/Aldurazyme Placebo/Aldurazyme At 208 weeks
Icelandic: Aldurazyme/Aldurazyme lyfleysa/Aldurazyme í 208 vikur í 182 vikur
English: The total volume of the administration should be delivered in approximately 3-4 hours.
Icelandic: Gefa á allt lyfið á um það bil 3-4 klukkustundum.
English: You should not be given this medicine after the expiry date which is stated on the label after the letters EXP.
Icelandic: Ekki skal nota lyfið eftir fyrningardagsetningu sem tilgreind er á umbúðunum á eftir EXP.
English: Patients were enrolled with a Forced Vital Capacity (FVC) less than 80% of the predicted value and had to be able to stand for 6 minutes and to walk 5 meters.
Icelandic: Sjúklingar sem gátu tekið þátt í rannsókninni voru með venjulega þvingaða öndunarrýmd (forced vital capacity [FVC]) minni en 80% af áætluðu gildi og urðu að geta staðið í 6 mínútur og gengið 5 metra.
English: Several patients showed an increase in height (n=7) and weight (n=3) for age Z-score.
Icelandic: Nokkrir sjúklingar hækkuðu (n=7) og þyngdust (n=3) umfram staðalskor fyrir sinn aldur (age Z-score).
English: All patients subsequently enrolled in an open label extension study where they all received 100 U/kg of Aldurazyme every week for an additional 3.5 years (182 weeks).
Icelandic: Allir sjúklingar tóku síðan þátt í opinni (open label) framhaldsrannsókn þar sem allir fengu 100 U/kg af Aldurazyme vikulega í 3,5 ár til viðbótar (182 vikur).