FrancophonIA/ELRC3.0 huggingface dataset:
English: 4 Additional adverse reactions from post-marketing, expanded access programs and non-controlled clinical trials.
Icelandic: 4 Viðbótaraukaverkanir sem tilkynnt var um eftir markaðssetningu, í tilvikum þar sem gefin var undanþága fyrir notkun lyfsins áður en lyfið var samþykkt (expanded access program) og í klínískum rannsóknum sem ekki voru samanburðarrannsóknir.
English: What Myozyme looks like and contents of the pack
Icelandic: Lýsing á útliti Myozyme og pakkningastærðir
English: • Fever or increased body temperature
Icelandic: Hiti eða aukinn líkamshiti
English: • Narrowing of the blood vessels causing blood flow to be decreased
Icelandic: Þrenging æða sem hægir á blóðflæði
English: Nausea3
Icelandic: VIÐAUKI III
English: Late-onset Pompe disease; other clinical trials and analyses Three independent, open-label, single arm, investigator-initiated studies with Myozyme were conducted:
Icelandic: Þrjár óháðar, opnar, einarma rannsóknir með Myozyme gerðar fyrir tilstuðlan rannsakanda:
English: In a placebo-controlled study lasting 78 weeks, 90 patients with late-onset Pompe disease, aged 10 to 70 years, were treated with Myozyme or placebo randomized in a 2:1 ratio (see section 5.1).
Icelandic: Pompe-sjúkdóm, á aldrinum 10 til 70 ára, Myozyme eða lyfleysu af handahófi í hlutfallinu 2:1 (sjá kafla 5.1).
English: Patients with late-onset Pompe disease typically present with progressive myopathy, predominantly of the proximal muscles in the pelvic and shoulder girdles, and varying degrees of respiratory involvement, ultimately progressing to profound disability and/or the need for ventilatory support.
Icelandic: Pompe-sjúkdóm fá venjulega vaxandi vöðvakvilla, einkum í nærlægum vöðvum við mjaðma- og axlagrind, og sjúkdómurinn nær mismikið til öndunarfæranna en ágerist að lokum í mjög alvarlega fötlun og/eða þörf á öndunarhjálp.
English: There are no clinical data on the effects of alglucosidase alfa on fertility.
Icelandic: Engar klínískar upplýsingar liggja fyrir um áhrif alglucosidasa alfa á frjósemi.
English: Myozyme has to be reconstituted with water for injections, then diluted with sodium chloride 9 mg/ml (0.9%) solution for injection and then administered by intravenous infusion.
Icelandic: Leysa þarf Myozyme upp í vatni fyrir stungulyf, þynna það síðan með natríumklóríð 9 mg/ml (0,9%) stungulyfi, lausn, og gefa það svo með innrennsli í bláæð.
English: Tilt and roll each vial gently.
Icelandic: Halla skal og snúa hverju hettuglasi varlega.
English: Some patients have been successfully rechallenged and continued to receive alglucosidase alfa under close clinical supervision.
Icelandic: Sumir sjúklingar hafa fengið alglucosidasa alfa aftur með góðum árangri og haldið áfram að fá lyfið undir ströngu klínísku eftirliti.
English: Symptoms of such reactions include low blood pressure, very fast heart rate, difficulty breathing, vomiting, facial, lip or tongue swelling, hives or rash.
Icelandic: Einkenni um slíkar aukaverkanir eru lágur blóðþrýstingur, mjög hraður hjartsláttur, öndunarerfiðleikar, uppköst, andlitsþroti þroti á vörum og tungu, ofsakláði eða útbrot.
English: Better treatment responses were observed in younger patients with less advanced disease who received prophylactic ITI before development of HSAT, which suggests that early initiation of ITI can result in improved clinical outcomes.
Icelandic: Betri meðferðarsvörun var hjá yngri sjúklingum með sjúkdóm sem var skemur á veg kominn sem fengu fyrirbyggjandi meðferð til þess að framkalla ónæmisþol áður en hár og varanlegur mótefnatítri kom fram sem bendir til þess að ef meðferð til þess að framkalla ónæmisþol er hafin snemma getur það bætt klínískan ávinning.
English: Due to the small patient population, an adverse reaction reported in 2 patients is classified as common.
Icelandic: Vegna þess hve fáir sjúklingar voru rannsakaðir, eru aukaverkanir sem greint var frá hjá 2 sjúklingum flokkaðar sem algengar.
English: After reconstitution it is a clear, colourless to pale yellow solution, which may contain particles.
Icelandic: Eftir blöndun er lausnin tær, litlaus eða örlítið gulleit og hugsanlegt er að hún innihaldi agnir.
English: Patients received 20 mg/kg Myozyme once every two weeks for 26 weeks.
Icelandic: Myozyme 20 mg/kg einu sinni á tveggja vikna fresti í 26 vikur.
English: Deficiency of this enzyme leads to glycogen accumulation in various tissues, particularly cardiac, respiratory and skeletal muscle, leading to the development of hypertrophic cardiomyopathy and progressive muscle weakness, including impairment of respiratory function.
Icelandic: Skortur á þessu ensími leiðir til uppsöfnunar glýkógens í ýmsum vefjum, sérstaklega í hjarta, öndunarfæra- og beinagrindarvöðvum sem leiðir til ofvaxtarhjartavöðvakvilla og stigvaxandi vöðvamáttleysis, þ.m.t. skertrar öndunarstarfsemi.
English: A non-typical, more slowly progressive form of infantile-onset Pompe disease has been described which is characterised by a less severe cardiomyopathy and consequently a more prolonged survival.
Icelandic: Pompe-sjúkdómi frá barnæsku sem ágerist hægar og einkennist af því að hjartavöðvakvilli er ekki eins alvarlegur og lifun því lengri.
English: Eye disorders not known
Icelandic: Augu tíðni ekki þekkt
English: As measured by motor performance age-equivalent scores of the Alberta Infant Motor Scale (AIMS), seven of the 18 patients made motor development gains during the study and were walking independently by the last study assessment (with individual patient treatment durations ranging from 52 to 130 weeks; mean follow-up period of 94 weeks).
Icelandic: öðluðust aukna hreyfigetu miðað við upphafsgildi metið sem hreyfigetualdursjafngildisskor samkvæmt Alberta Infant Motor skalanum (AIMS) og gátu gengið af sjálfsdáðum miðað við síðasta fáanlega mat rannsóknarinnar (þar sem lengd meðhöndlunar fyrir hvern sjúkling var frá 52 að 130 vikur, miðgildi tímabils eftirfylgni var 94 vikur).
English: Do not shake or excessively agitate the infusion bag.
Icelandic: Ekki má hrista pokann eða hreyfa við honum á harkalegan hátt.
English: Serious adverse reactions reported in 4 patients treated with Myozyme were: angioedema, chest discomfort, throat tightness, non-cardiac chest pain and supraventricular tachycardia.
Icelandic: Myozyme voru eftirfarandi: ofsabjúgur, óþægindi fyrir brjósti, herpingur í hálsi, brjóstverkur (ekki í tengslum við hjarta) og ofansleglahraðtaktur.
English: Patients treated with Myozyme demonstrated prolonged survival as compared to survival in an untreated historical cohort (see Table 2).
Icelandic: Lifun sjúklinga sem meðhöndlaðir voru með Myozyme reyndist vera lengri í samanburði við lifun hjá ómeðhöndluðum sögulegum samanburðarhópi.
English: The pH of the reconstituted solution is approximately 6.2.
Icelandic: Sýrustig lausnarinnar er u.þ.b. 6,2.
English: Immune-mediated reactions
Icelandic: Mótefna-miðluð viðbrögð
English: Excipients:
Icelandic: Ath.:
English: In a pivotal trial including 18 patients, the pharmacokinetics of alglucosidase alfa were evaluated in 15 patients with infantile-onset Pompe disease (all less than 6 months of age at treatment-onset) who received doses of 20 mg/kg or 40 mg/kg alglucosidase alfa as an approximate 4 to 6.5-hour infusion, respectively.
Icelandic: Í grunnrannsókn sem í tóku þátt 18 sjúklingar voru lyfjahvörf algucosidasa alfa metin hjá 15 sjúklingum sem fengið höfðu Pompe-sjúkdóm í barnæsku (allir sjúklingarnir voru innan við 6 mánaða að aldri þegar meðferð hófst) og þeim var gefinn alglucosidasa alfa 20 mg/kg eða 40 mg/kg með innrennsli á u.þ.b. 4-6,5 klst., tilgreint í sömu röð.
English: At 104 weeks of treatment LVM assessments were available for 8 patients, of which 5 decreased to within normal limits.
Icelandic: Eftir 104 vikur meðhöndlunar var mat á massa vinstra slegils fáanlegt fyrir 8 sjúklinga og minnkaði massinn hjá 5 þeirra að eðlilegum mörkum.
English: • Swelling and thickening of the skin at infusion site in case of leakage of the product outside blood vessels
Icelandic: Þroti og þykknun húðar á innrennslistað ef lyfið lekur út fyrir æðina.
English: This should then be further diluted as follows: Slowly withdraw the reconstituted solution from each vial until the volume for the patient's dose is obtained.
Icelandic: Dragið lausnina varlega úr hverju hettuglasi þar til nægilegum skammti er náð fyrir viðkomandi sjúkling.
English: When reconstituted as above, the reconstituted solution in the vial contains 5 mg alglucosidase alfa per ml.
Icelandic: Þegar lyfið hefur verið leyst upp sem lýst er hér að framan inniheldur lausnin í hettuglasinu 5 mg af alglucosidasa alfa í hverjum ml.
English: If you forget to use Myozyme
Icelandic: Áður en byrjað er að nota Myozyme
English: After 52 weeks of treatment, LVM decreased from baseline in all 14 patients with available data and was within normal limits in 3 of 14 patients.
Icelandic: Eftir 52 vikur meðferðar hafði dregið úr massa vinstri slegils frá fyrsta mati til þess síðasta hjá öllum 14 sjúklingunum miðað við fáanleg gögn, og var innan eðlilegra marka hjá 3 af 14 sjúklingum.
English: • Nephrotic Syndrome: swelling of lower limbs, generalized swelling and protein loss in urine
Icelandic: Nýrungaheilkenni: bólgur í fótleggjum, almennur þroti og prótein í þvagi
English: • Pain or local reaction at the site of the drip
Icelandic: Sársauki eða staðbundin áhrif á innrennslisstað
English: There was no evidence that IgG antibodies to alglucosidase alfa affected pharmacokinetics.
Icelandic: Ekkert benti til þess að IgG-mótefni við alglucosidasa alfa hefðu áhrif á lyfjahvörf.
English: Late-onset Pompe disease
Icelandic: Síðkominn Pompe-sjúkdómur
English: • Tingling
Icelandic: Sundl
English: The most common adverse reactions observed were IARs.
Icelandic: Algengustu aukaverkanirnar sem komu fram voru innrennslistengdar aukaverkanir.
English: Usually, it is characterised by the presence of sufficient residual GAA activity to preclude the development of cardiomyopathy, however some cardiac involvement has been reported in up to approximately 4% of patients with late-onset Pompe disease.
Icelandic: Venjulega er nægilega mikil GAA virkni eftir til að koma í veg fyrir hjartavöðvakvilla, en hins vegar hefur verið greint frá því að sjúkdómurinn nái að einhverju leyti til hjartans hjá u.þ.b.
English: At 104 weeks of treatment LVM assessments were available for 10 patients, of which 9 decreased to within normal limits.
Icelandic: Eftir 104 vikur meðhöndlunar var mat á massa vinstri slegils fáanlegt fyrir 10 sjúklinga og lækkaði hann í hjá 9 sjúklingum að eðlilegum mörkum.
English: SANOFI BULGARIA EOOD
Icelandic: Sanofi AB
English: 2 Reactions reported in 60 late-onset patients in a placebo-controlled clinical trial.
Icelandic: 2 Aukaverkanir sem greint var frá hjá 60 sjúklingum með síðkominn sjúkdóm í klínískri samanburðarrannsókn með lyfleysu.
English: • Redness of the skin
Icelandic: Roði í húð
English: Muscle spasms Muscle twitching Myalgia not known
Icelandic: Vöðvakrampar Vöðvakippir Vöðvaþrautir tíðni ekki þekkt
English: Confidence Interval p-value
Icelandic: 95% öryggisbil p-gildi
English: Throat tightness not known
Icelandic: Herpingur í hálsi tíðni ekki þekkt
English: Benefits of treatment on motor function including the regaining of lost motor skills were observed in some patients.
Icelandic: Jákvæð áhrif meðferðar á hreyfigetu voru meðal annars endurheimt glataðrar hreyfifærni.
English: Method of administration Myozyme should be administered as an intravenous infusion.
Icelandic: Lyfjagjöf Myozyme skal gefið með innrennsli í bláæð.
English: Vascular disorders very common
Icelandic: Meltingarfær i mjög algengar
English: 25 vials powder for concentrate for solution for infusion.
Icelandic: 25 hettuglös stofn fyrir innrennslisþykkni, lausn.
English: Reduction of the infusion rate, temporary interruption of the infusion, or pre-treatment, generally with oral antihistamine and/or antipyretics and/or corticosteroids, has effectively managed most reactions.
Icelandic: Hægt hefur verið að hafa stjórn á flestum áhrifunum með því að draga úr innrennslishraða, hætta innrennsli tímabundið eða með formeðferð, yfirleitt með andhistamínum til inntöku og/eða hitalækkandi lyfjum og/eða barksterum.
English: Patient response to treatment should be routinely evaluated based on a comprehensive evaluation of all clinical manifestations of the disease.
Icelandic: Reglulega skal meta svörun sjúklinga við meðferð samkvæmt ítarlegu mati á öllum klínískum sjúkdómseinkennum.
English: After 78 weeks, patients treated with Myozyme showed improvement in distance walked as measured by 6MWT and stabilization of pulmonary function as measured by FVC % predicted as compared to placebo-treated patients.
Icelandic: Myozyme framfarir í genginni vegalengd, mælt með 6MWT og stöðuga lungnastarfsemi, mælt með FVC % metið í samanburði við sjúklinga sem fengu lyfleysu.
English: Paediatric and older people
Icelandic: Börn og aldraðir
English: Symptoms of life-threatening allergic reactions include, but are not limited to, low blood pressure, very fast heart rate, difficulty breathing, vomiting, facial swelling, hives or rash.
Icelandic: Meðal einkenna lífshættulegra ofnæmisviðbragða eru lágur blóðþrýstingur, mjög hraður hjartsláttur, öndunarerfiðleikar, uppköst, andlitsþroti, ofsakláði eða útbrot.
English: Due to the proteinaceous nature of the product, particle formation may occur in the reconstituted solution and final infusion bags.
Icelandic: Próteineiginleikar lyfsins geta valdið því að agnir myndast í uppleystri lausninni og innrennslispokunum.
English: The reconstituted solution must be further diluted.
Icelandic: Þynna þarf lausnina frekar.
English: Severe cutaneous reactions, possibly immune mediated, have been reported with alglucosidase alfa, including ulcerative and necrotizing skin lesions (see section 4.8).
Icelandic: Greint hefur verið frá alvarlegum viðbrögðum í húð, hugsanlega mótefna-miðluðum, við notkun alglucosidasa alfa, þ.m.t. sár og drepsár í húð (sjá kafla 4.8).
English: Adverse reactions were mostly mild to moderate in intensity and almost all occurred during the infusion or during the 2 hours following the infusion (infusion associated reactions, IARs).
Icelandic: Aukaverkanirnar voru yfirleitt vægar eða í meðallagi og þær komu nánast allar fram meðan á innrennsli stóð eða innan 2 klst.
English: Hypersensitivity/Anaphylactic reactions
Icelandic: Ofnæmi/bráðaofnæmisviðbrögð
English: Each vial contains 50 mg of alglucosidase alfa.
Icelandic: 50 mg af alglucosidasa alfa
English: • Increased heart rate
Icelandic: Hægari hjartsláttur
English: Use aseptic technique
Icelandic: Beitið smitgátartækni
English: Of the 21 patients, 16 survived through the end of this study, with a median time from ERT initiation to last assessment of 44.6 months (range: 5.7 to 105.47); 5 patients died due to respiratory failure and disease progression, all of whom were ERTnaïve at the start of ERT+ITI treatment.
Icelandic: Af þessum 21 sjúklingi voru 16 á lífi við lok rannsóknarinnar þar sem miðgildistími ensímuppbótarmeðferðar fram að síðasta mati var 44,6 mánuðir (á bilinu:
English: Cardiac disorders very common
Icelandic: Hjarta mjög algengar
English: In the rabbit embryofoetal development study, following administration of Myozyme (10-40 mg/kg/day) with coadministration of diphenhydramine, a treatment-related increase in the incidence of abortions and early delivery was observed.
Icelandic: Í rannsókninni á þroska fósturvísis/fósturs hjá kanínum kom fram meðferðartengd aukin tíðni fósturláta og gota fyrir tímann í kjölfar lyfjagjafar með Myozyme (1040 mg/kg á dag) með samhliða gjöf diphenhýdramíns.
English: Nephrotic syndrome as well as severe cutaneous reactions, possibly immune mediated, have been reported with alglucosidase alfa including ulcerative and necrotizing skin lesions (see section 4.4).
Icelandic: Greint hefur verið frá nýrungaheilkenni auk alvarlegra viðbragða í húð, hugsanlega mótefnamiðluðum, við notkun alglucosidasa alfa, þ.m.t. sár og drepsár í húð (sjá kafla 4.4).
English: An open-label clinical trial assessed the safety and efficacy of Myozyme in 5 patients with late-onset Pompe disease who ranged in age from 5 to 15 years at initiation of treatment (AGLU02804).
Icelandic: Pompe-sjúkdóm og voru 5 til 15 ára þegar meðferð (AGLU02804) hófst.
English: Serious infusion reactions including urticaria, rales, tachycardia, decreased oxygen saturation, bronchospasm, tachypnea, periorbital edema and hypertension have been reported.
Icelandic: Alvarlegar innrennslistengdar aukaverkanir sem hafa greinst eru ofsakláði, hrygluhljóð, hraðtaktur, minnkuð súrefnismettun, berkjukrampar, hraðöndun, bjúgur umhverfis augu og háþrýstingur.
English: It is recommended that the infusion begin at an initial rate of 1 mg/kg/h and be gradually increased by 2 mg/kg/h every 30 minutes if there are no signs of infusion associated reactions (IARs) until a maximum rate of 7 mg/kg/h is reached.
Icelandic: á 30 mínútna fresti ef ekki koma fram nein merki um innrennslistengdar aukaverkanir, þar til hámarkshraðanum 7 mg/kg/klst. er náð.
English: After reconstitution, the solution contains 5 mg of alglucosidase alfa/ml and after dilution, the concentration varies from 0.5 mg to 4 mg/ml.
Icelandic: Eftir blöndun inniheldur lausnin 5 mg af alglucosidasa alfa/ml og eftir þynningu er styrkur á bilinu 0,5 mg til 4 mg/ml.
English: Diarrhoea Vomiting
Icelandic: Pompesjúkdómur
English: Reference
Icelandic: UPPLÝSINGAR
English: Tremor Headache
Icelandic: Skjálfti Höfuðverkur
English: Contents of the pack and other information What Myozyme contains
Icelandic: Hvernig geyma á Myozyme Pakkningar og aðrar upplýsingar
English: Renal and urinary disorders not known
Icelandic: Nýru og þvagfæri tíðni ekki þekkt
English: Life threatening reactions, including very severe generalised allergic reactions and anaphylactic shock, have been reported in some patients.
Icelandic: Tilkynnt hefur verið um lífshættuleg viðbrögð hjá sumum sjúklingum, þ.á m. mjög alvarleg almenn ofnæmisviðbrögð og bráðaofnæmislost.
English: Paasheuvelweg 25
Icelandic: Bjúgur á útlimum
English: Peripheral coldness Infusion site pain Infusion site reaction Infusion site swelling Infusion site induration
Icelandic: Verkur á innrennslisstað Viðbrögð á innrennslisstað Þroti á innrennslisstað Herslismyndun á innrennslisstað Utanæðaleki (extravasation) á innrennslisstað
English: Respiratory distress Bronchospasm Wheezing Pharyngeal oedema Dyspnoea Tachypnoea Throat tightness Stridor
Icelandic: Útbrot algengar Roði í húð Dröfnuörðuútbrot
English: 10 vials powder for concentrate for solution for infusion.
Icelandic: 10 hettuglös stofn fyrir innrennslisþykkni, lausn.
English: Mean ± s.d.
Icelandic: Sanofi S.p.A.
English: Marketing Authorisation Holder Genzyme Europe B.V.
Icelandic: Markaðsleyfishafi Genzyme Europe B.V., Paasheuvelweg
English: After reconstitution, the solution contains 5 mg of alglucosidase alfa per ml and after dilution the concentration varies from 0.5 mg to 4 mg/ml.
Icelandic: Eftir blöndun inniheldur lausnin 5 mg af alglucosidasa alfa í hverjum ml og eftir þynningu er styrkur á bilinu 0,5 mg til 4 mg/ml.
English: Periorbital edema Livedo reticularis Lacrimation increased Rash
Icelandic: Marmarahúð (livedo reticularis)
English: • Increased sweating
Icelandic: Aukin svitamyndun
English: After reconstitution, the solution contains 5 mg of alglucosidase alfa* per ml and after dilution, the concentration varies from 0.5 mg to 4 mg/ml.
Icelandic: Eftir blöndun inniheldur lausnin 5 mg af alglucosidasa alfa* í hverjum ml og eftir þynningu er styrkur lausnarinnar á bilinu 0,5 mg til 4 mg/ml.
English: Myozyme is given through a drip into a vein (by intravenous infusion).
Icelandic: Myozyme er gefið með innrennsli í bláæð.
English: Patients with moderate to severe or recurrent IARs have been evaluated for alglucosidase alfa specific IgE antibodies; some patients tested positive including some who experienced an anaphylactic reaction.
Icelandic: Sjúklingar með í meðallagi alvarlegar til alvarlegar eða endurteknar innrennslistengdar aukaverkanir voru metnir með tilliti til sértækra alglucosidasa alfa IgE mótefna.
English: Dilution
Icelandic: Hitatilfinning
English: Feeling hot not known
Icelandic: Æsingur tíðni ekki þekkt
English: Oxygen saturation decreased
Icelandic: Minnkuð súrefnismettun Hraðari hjartsláttur
English: Wilcoxon-Mann-Whitney Test p-value Forced Vital Capacity (Percent of predicted normal) Pre-treatment Baseline
Icelandic: Wilcoxon-Mann-Whitney próf p-gildi *Engin gögn voru fyrirliggjandi um einn sjúklinginn í byrjun meðferðar og var hann útilokaður úr greiningu á niðurstöðunum.
English: Mean ± s.d Median
Icelandic: Öndunarerfiðleikar (þ.m.t. mæði)
English: Infantile-onset Pompe disease1
Icelandic: INNRI UMBÚÐUM LÍTILLA EININGA
English: General disorders and administration site conditions very common
Icelandic: Almennar aukaverkanir og aukaverkanir á íkomustað mjög algengar
English: The majority of these reactions were non-serious, mild to moderate in intensity and resolved spontaneously.
Icelandic: vægar eða í miðlungi alvarlegar og gengu sjálfkrafa til baka.
English: How Myozyme is given
Icelandic: Myozyme inniheldur
English: Justification for not including Braille accepted
Icelandic: Kuldahrollur Óþægindi fyrir brjósti Pirringur
English: See section 4
Icelandic: Tafla 4:
English: • Swelling of the arms and legs
Icelandic: Bólgnir hand- og fótleggir
English: Face edema Feeling hot Pyrexia
Icelandic: Sótthiti algengar Pirringur Kuldahrollur
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Icelandic: Látið lækninn, eða lyfjafræðing eða hjúkrunarfræðinginn vita um allar aukaverkanir.
English: Alglucosidase alfa
Icelandic: Ónæmiskerfi algengar
English: Hypersensitivity
Icelandic: Tilfinningarglöp
English: Based on these results the 20 mg/kg qow dose is recommended.
Icelandic: Á grundvelli þessara niðurstaðna er mælt með að nota 20 mg/kg skammtinn aðra hverja viku.
English: 1 vial powder for concentrate for solution for infusion.
Icelandic: 1 hettuglas stofn fyrir innrennslisþykkni, lausn.
English: Higher mean clearance, lower mean AUC∞, and lower mean Cmax were observed in 5 patients who tested positive for inhibition of cellular uptake of enzyme.
Icelandic: Cmax kom fram hjá 5 sjúklingum sem reyndust jákvæðir fyrir hömlun á frumuupptöku ensíms.
English: • Eyes tearing
Icelandic: Þroti í kringum augu
English: Nervous system disorders common Tremor
Icelandic: Taugakerfi algengar Skjálfti
English: • Itchy skin
Icelandic: Blámi húðar
English: There are no data from the use of alglucosidase alfa in pregnant women.
Icelandic: Ekki liggja fyrir neinar upplýsingar um notkun alglucosidasa alfa á meðgöngu.
English: Conjunctivitis
Icelandic: Einnota
English: Nephrotic syndrome Proteinuria
Icelandic: Cox aðhvarfslíkans
English: Hypertension Hypotension Vasoconstriction Pallor
Icelandic: Kuldatilfinning í útlimum
English: In these patients renal biopsy showed immune complex deposition.
Icelandic: Vefjasýni úr nýrum sýndu fram á útfellingu ónæmisflétta hjá þessum sjúklingum.
English: Distribution and elimination
Icelandic: ÁLETRANIR OG FYLGISEÐILL
English: After 52 weeks of treatment, 3 out of 8 patients with available data made gains in motor function over baseline as measured by raw scores and age-equivalent scores from baseline in the AIMS.
Icelandic: 3 af 8 sjúklingum sem til voru gögn um, aukna hreyfigetu frá upphafsgildi, bæði mælt beint og aldurstengt frá upphafi rannsóknar samkvæmt Alberta Infant Motor skalanum (AIMS).
English: The time course of disease progression is extremely variable and not predictable, with some patients experiencing a rapid deterioration in skeletal and respiratory muscle function leading to loss of ambulation and respiratory failure, others progressing less rapidly, and yet others presenting with a dissociation in the progression of skeletal and respiratory muscle involvement.
Icelandic: Hjá öðrum versnar sjúkdómurinn hægar og hjá enn öðrum er misræmi í framgangi sjúkdómsins hvað varðar beinagrindar- og öndunarvöðva.