FrancophonIA/ELRC3.0 huggingface dataset:
English: Plastic ampoule of water for injection
Danish: Plastampul med vand til injektionsvæsker
English: 12) Insert the needle of the 3 mL syringe containing the 2.2 mL of water for injection all the way into the Myalepta vial containing the powder.
Danish: 12) Sæt kanylen på 3 ml-sprøjten med de 2,2 ml vand til injektionsvæsker helt ind i hætteglasset, som indeholder Myalepta-pulveret.
English: These will have been given to you by your doctor, nurse, or pharmacist.
Danish: Lægen, sundhedspersonalet eller apotekspersonalet har givet dem til dig.
English: Generalised LD
Danish: Efter i.v.
English: The individual patient dose = 0.9 mg. A dose increment of 0.02 mg/kg increases the daily dose to 0.08 mg/kg = 1.2 mg. Total daily volume to be injected is total dose in mg/5, in this case it is 1.2 mg/5 = 0.24 mL which equals 24 units on the 0.3 mL insulin syringe.
Danish: Det samlede daglige volumen til injektion er den samlede dosis i mg/5, som i dette tilfælde er 1,2 mg/5 = 0,24 ml, hvilket svarer til 24 enheder på 0,3 ml-insulinsprøjten.
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.
Danish: Det er et hvidt pulver, som leveres i et hætteglas af glas med en gummiprop og en aluminiumsforsegling med et hvidt flip-off-låg af plast.
English: Myalepta 5.8 mg powder for solution for injection Using a 3 mL syringe with a 21-gauge or smaller diameter needle, withdraw 1.1 mL of water for injection.
Danish: Myalepta 5,8 mg pulver til injektionsvæske, opløsning Brug en 3 ml-sprøjte med en 21-gauge kanyle eller en kanyle med en mindre diameter til at trække 1,1 ml vand til injektionsvæsker op.
English: • chest infection
Danish: • lunge-/luftvejsinfektion
English: Myalepta 5.8 mg powder for solution for injection Each vial contains 5.8 mg of metreleptin*.
Danish: Myalepta 5,8 mg pulver til injektionsvæske, opløsning Et hætteglas indeholder 5,8 mg metreleptin*.
English: Myalepta 3 mg powder for solution for injection Each vial contains 3 mg of metreleptin*.
Danish: Myalepta 3 mg pulver til injektionsvæske, opløsning Et hætteglas indeholder 3 mg metreleptin*.
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.
Danish: Det er et hvidt pulver, som leveres i et hætteglas af glas med en gummiprop og en aluminiumsforsegling med et rødt flip-off-låg af plast.
English: Serious adverse reactions were reported in 2 patients, worsening hypertension and anaplastic large cell lymphoma.
Danish: Hos patienter med generaliseret lipodystrofi var den samlede forekomst af bivirkninger den samme uanset alder. Der blev rapporteret alvorlige bivirkninger hos 2 patienter, forværring af hypertension og anaplastisk storcellelymfom.
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.
Danish: Myalepta 11,3 mg pulver til injektionsvæske, opløsning Brug en 3 ml-sprøjte med en 21-gauge kanyle eller en kanyle med en mindre diameter til at trække 2,2 ml vand til injektionsvæsker op.
English: Attach the needle to the 3 mL syringe.
Danish: Sæt kanylen på 3 ml-sprøjten.
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.
Danish: Myalepta 3 mg pulver til injektionsvæske, opløsning Brug en 1 ml-sprøjte med en 21-gauge kanyle eller en kanyle med en mindre diameter til at trække 0,6 ml vand til injektionsvæsker op.
English: Myalepta 3 mg powder for solution for injection 1.0 mL
Danish: Myalepta 3 mg pulver til injektionsvæske, opløsning 1,0 ml
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.
Danish: Træk forsigtigt stemplet ned • Træk det ned, indtil stemplets øverste kant flugter med den sorte 1,1 ml-streg.
English: o Hypoglycaemia with concomitant use of insulin and other antidiabetics may occur.
Danish: o Der kan forekomme hypoglykæmi med samtidig brug af insulin og andre antidiabetika.
English: 0.156 mL 0.15 mL
Danish: 0,156 ml
English: • fainting or feeling dizzy
Danish: • besvimelse eller svimmelhed
English: Menorrhagia
Danish: Vægttab
English: Each vial contains 3 mg of metreleptin After reconstitution, each mL contains 5 mg of metreleptin (5 mg/mL)
Danish: Et hætteglas indeholder 3 mg metreleptin Efter rekonstitution indeholder én ml 5 mg metreleptin (5 mg/ml)
English: • Without the needle attached, insert the 1 mL syringe tip into the top of the plastic ampoule as far as possible.
Danish: • Sæt spidsen af 1 ml-sprøjten uden kanyle så langt ned i plastampullen oppefra, som den kan komme.
English: • Pull up until the top rim of the plunger lines up with the black 1.1 mL line.
Danish: • Træk op, indtil stemplets øverste kant flugter med den sorte 1,1 ml-streg.
English: o Serious and severe infections secondary to the appearance of NAb may occur.
Danish: o Der kan forekomme alvorlige og svære infektioner som følge af udviklingen af neutraliserende antistoffer.
English: • Without the needle attached, insert the 3 mL syringe tip into the top of the plastic ampoule as far as possible.
Danish: • Sæt spidsen af 3 ml-sprøjten uden kanyle så langt ned i plastampullen oppefra, som den kan komme.
English: Attach the needle to the 1 mL syringe.
Danish: Sæt kanylen på 1 ml-sprøjten.
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.
Danish: Træk forsigtigt stemplet ned • Træk det ned, indtil stemplets øverste kant flugter med den sorte 0,6 ml-streg.
English: Do not use this medicine if the solution is not clear, is coloured or has bits or lumps in it. Do not throw away any medicines via wastewater or household waste.
Danish: Brug ikke lægemidlet, hvis opløsningen ikke er klar, er misfarvet eller har klumper.
English: Before opening the water for injection ampoule, prepare the 1 mL syringe by attaching the needle to it. Do not over-tighten the needle.
Danish: Inden du åbner ampullen med vand til injektionsvæsker, skal du klargøre 1 ml-sprøjten ved at sætte kanylen på den.
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.
Danish: Træk forsigtigt stemplet ned • Træk det ned, indtil stemplets øverste kant flugter med den sorte 2,2 ml-streg.
English: A total of 8 (24%) of the 34 patients with generalised LD who were receiving lipid-lowering therapies at baseline discontinued their use during metreleptin treatment.
Danish: Af de 32 patienter med generaliseret lipodystrofi, som fik orale antidiabetika ved baseline, kunne 7 (22 %) seponere brugen af dem. I alt 8 (24 %) af de 34 patienter med generaliseret lipodystrofi, som fik lipidsænkende behandling ved baseline, seponerede brugen af dette under behandlingen med metreleptin.
English: For females > 40 kg once daily dose
Danish: Dosis en gang dagligt for kvinder > 40 kg
English: • feeling tired
Danish: • føle sig svimmel
English: For males and females ≤ 40 kg once daily dose
Danish: Dosis en gang dagligt for mænd og kvinder ≤ 40 kg
English: Glass vial of water for injection
Danish: Hætteglas af glas med vand til injektionsvæsker
English: • Pull up until the top rim of the plunger lines up with the black 0.6 mL line.
Danish: • Træk op, indtil stemplets øverste kant flugter med den sorte 0,6 ml-streg.
English: Myalepta 3 mg powder for injection metreleptin
Danish: Myalepta 3 mg pulver til injektionsvæske metreleptin
English: HbA1c ≥ 8%.
Danish: ≥ 5,65 mmol/l og/eller HbA1c ≥ 8 %.
English: Myalepta 11.3 mg powder for injection metreleptin
Danish: Myalepta 11,3 mg pulver til injektionsvæske metreleptin
English: • Pull up until the top rim of the plunger lines up with the black 2.2 mL line.
Danish: • Træk op, indtil stemplets øverste kant flugter med den sorte 2,2 ml-streg.
English: • Hold the ampoule so that the top is facing up.
Danish: • Hold ampullen med toppen opad.
English: 0.168 mL 0.16 mL
Danish: 0,168 ml
English: 0.204 mL 0.20 mL
Danish: 0,204 ml
English: Myalepta 5.8 mg powder for injection metreleptin
Danish: Myalepta 5,8 mg pulver til injektionsvæske metreleptin
English: See the
Danish: Se pkt.
English: 0.144 mL 0.14 mL
Danish: 0,144 ml
English: Across two completed clinical studies (NIH 991265/20010769 and FHA101), there were 52 paediatric patients (4 in the subgroup of partial LD patients and 48 with generalised LD) enrolled and exposed to metreleptin.
Danish: 52 pædiatriske patienter (4 i undergruppen af patienter med partiel lipodystrofi og 48 med generaliseret lipodystrofi) deltog og blev eksponeret for metreleptin i to fuldførte kliniske studier (NIH 991265/20010769 og FHA101).
English: White lyophilised cake or powder.
Danish: bobler og skum.
English: 0.252 mL 0.25 mL
Danish: 0,252 ml
English: • stomach pain, feeling sick (nausea) and being sick (vomiting)
Danish: • mavesmerter, kvalme og opkastning
English: 0.132 mL 0.13 mL
Danish: 0,132 ml
English: Rotation of injection sites is recommended in patients co-administering insulin (or other subcutaneous medicinal products) and Myalepta.
Danish: Patienter, som får insulin (eller andre subkutane lægemidler) samtidig med Myalepta, anbefales at bruge forskellige injektionssteder.
English: 0.288 mL 0.28 mL
Danish: 0,288 ml
English: - Rotation of injection sites is recommended in patients co administering insulin (or other SC medicinal products) and Myalepta.
Danish: - Patienter, som får insulin (eller andre subkutane lægemidler) samtidig med Myalepta, anbefales at bruge forskellige injektionssteder.
English: Cases of T-cell lymphoma (see section 4.8) have been reported while using Myalepta in clinical studies.
Danish: 4.8) under brug af Myalepta i kliniske studier.
English: • You will be given the 1 mL syringe to use if your daily dose is more than 1.5 mg up to 5 mg,
Danish: • Du får 1 ml-sprøjten, hvis din daglige dosis er over 1,5 mg op til 5 mg, der som volumen er over 0,3 ml op til 1,0 ml Myalepta-opløsning.
English: • Keeping the bottom of the ampoule still, snap the tip off.
Danish: • Hold bunden af ampullen stille, og knæk spidsen af.
English: 0.276 mL 0.27 mL
Danish: 0,276 ml
English: 0.180 mL 0.18 mL
Danish: 0,180 ml
English: 0.192 mL 0.19 mL
Danish: 0,192 ml
English: 0.108 mL 0.10 mL
Danish: 0,108 ml
English: • Insert the 3 mL syringe needle into the vial, through the rubber seal.
Danish: • Sæt 3 ml-sprøjten ind i hætteglasset gennem gummiforseglingen.
English: • feeling sick or being sick
Danish: • have kvalme eller kaste op
English: 0.264 mL 0.26 mL
Danish: 0,264 ml
English: Type I glass vial (3 mL) with a chlorobutyl rubber stopper and an aluminium seal/red plastic flip-off cap.
Danish: Myalepta 3 mg pulver til injektionsvæske, opløsning Hætteglas af type I glas (3 ml) med en gummiprop af chlorbutyl og en aluminiumsforsegling/et rødt flip-off-låg af plast.
English: If any of the above apply to you (or you are not sure), talk to your doctor before using Myalepta.
Danish: Tal med lægen, før du bruger Myalepta, hvis noget af ovennævnte gælder for dig, eller hvis du er i tvivl.
English: How to stop using Myalepta
Danish: Hvis du skal holde op med at bruge Myalepta
English: For males > 40 kg once daily dose
Danish: Dosis en gang dagligt for mænd > 40 kg
English: With the needle still in the ampoule, pull the plunger up carefully.
Danish: Træk forsigtigt stemplet op, mens kanylen stadig er i ampullen.
English: 0.240 mL 0.24 mL
Danish: 0,240 ml
English: syringe to inject
Danish: Aflæsning af sprøjten
English: Males and females ≤ 40 kg 0.06 mg/kg (0.012 mL/kg)
Danish: 0,06 mg/kg (0,012 ml/kg)
English: • Insert the 1 mL syringe needle into the vial, through the rubber seal.
Danish: • Sæt 1 ml-sprøjten ind i hætteglasset gennem gummiforseglingen.
English: 0.216 mL 0.21 mL
Danish: 0,216 ml
English: • feeling out of breath
Danish: • have åndenød.
English: Type I glass vial (3 mL) with a chlorobutyl rubber stopper and an aluminium seal/blue plastic flip-off cap.
Danish: Myalepta 5,8 mg pulver til injektionsvæske, opløsning Hætteglas af type I glas (3 ml) med en gummiprop af chlorbutyl og en aluminiumsforsegling/et blåt flip-off-låg af plast.
English: After dissolving the vial contents in 0.6 millilitres of water for injections, each millilitre contains 5 milligrams of metreleptin.
Danish: 0,6 milliliter vand til injektionsvæsker indeholder én milliliter 5 milligram metreleptin.
English: If you use more Myalepta than you should
Danish: Hvis du har brugt for meget Myalepta
English: 0.120 mL 0.12 mL
Danish: 0,120 ml
English: • feeling sleepy or confused
Danish: • træthed eller forvirring.
English: Hepatic Impairment
Danish: Generaliseret lipodystrofi
English: 0.228 mL 0.22 mL
Danish: 0,228 ml
English: • breathlessness
Danish: • ledsmerter
English: After reconstitution with 0.6 mL water for injections (see section 6.6), each mL contains 5 mg of metreleptin.
Danish: Efter rekonstitution med 0,6 ml vand til injektionsvæsker (se pkt.
English: • feeling sick (nausea) or being sick (vomiting)
Danish: • have kvalme eller kaste op.
English: At 182 weeks
Danish: Efter 182 Uger
English: Eighteen patients completed the study.
Danish: 18 patienter fuldførte studiet.
English: Cmax showed an increase over time.
Danish: Cmax udviste en stigning over tid.
English: This patient tested positive for IgE.
Danish: Denne patient testedes positiv for IgE.
English: Other side effects include the following:
Danish: Andre bivirkninger omfatter følgende:
English: ATC code: A16AB05.
Danish: ATC-kode: A16AB05.
English: Common (may affect up to 1 in 10 people)
Danish: Almindelig (kan ramme op til 1 ud af 10 personer)
English: Some of these reactions may be severe.
Danish: Nogle af disse reaktioner kan være alvorlige.
English: Aldurazyme was well tolerated at both dosages.
Danish: Aldurazyme blev tolereret godt i begge doseringer.
English: • cold hands or feet
Danish: • kolde hænder eller fødder
English: Antibody status should be regularly monitored and reported.
Danish: Antistofstatus skal overvåges jævnligt og indberettes.
English: From a microbiological safety point of view, the product should be used immediately.
Danish: Ud fra mikrobiologiske sikkerhedshensyn bør dette produkt anvendes med det samme.
English: The current medical standards for emergency treatment are to be observed.
Danish: De aktuelle medicinske standarder for akut behandling skal overholdes.
English: There are also links to other websites about rare diseases and treatments.
Danish: Der er også links til andre websteder om sjældne sygdomme, og om, hvordan de behandles.
English: 2 Both groups exceeded the minimal clinically important difference (-0.24)
Danish: 2 Begge grupper overskred den mindste klinisk vigtige forskel (-0,24).
English: As a result, these substances do not get broken down and processed by the body as they should.
Danish: Som følge deraf bliver disse stoffer ikke nedbrudt og bearbejdet af kroppen, som de ellers skulle.
English: Due to the small patient population, an ADR reported in a single patient is classified as common.
Danish: På grund af den lille patientpopulation er en ADR, der blev indberettet for en enkelt patient, klassificeret som almindelig.
English: • bluish color of the skin (due to lower levels of oxygen in the blood)
Danish: • blåfarvning af huden (grundet for lavt indhold af ilt i blodet)
English: The total volume of the administration should be delivered in approximately 3-4 hours.
Danish: Det totale volumen bør indgives i løbet af ca. 3-4 timer.
English: No definite benefit was shown with the higher doses over the recommended dose.
Danish: Der blev ikke påvist nogen definitiv fordel med de højere doser i forhold til den anbefalede dosis.
English: The majority of these reactions were mild or moderate in intensity.
Danish: Størstedelen af disse reaktioner var lette eller moderate i styrke.
English: The molecule contains 6 N-linked oligosaccharide modifications sites.
Danish: Molekylet indeholder 6 N-tilknyttede oligosakkaride modifikationssteder.
English: The frequency of bronchospasm and respiratory arrest is unknown.
Danish: Hyppigheden af bronkospasme og åndedrætsstop er ikke kendt.
English: Genotoxic and carcinogenic potential are not expected.
Danish: Der forventes ikke genotoksiske og carcinogene egenskaber.
English: The occurrence of IgE antibodies was not fully explored.
Danish: Forekomsten af IgE-antistoffer var ikke fuldt udforsket.
English: Over time the number of these reactions decreased.
Danish: Antallet af disse reaktioner blev reduceret med tiden.
English: Date of latest renewal: 10 June 2008
Danish: Dato for første tilladelse: 10. juni 2003 Dato for seneste fornyelse: 10. juni 2008
English: Paediatric population No dose adjustment is necessary for the paediatric population.
Danish: Pædiatrisk population Dosisjustering er ikke nødvendig hos den pædiatriske population.
English: This can replace the natural enzyme which is lacking in MPS I disease.
Danish: Det kan erstatte det naturlige enzym, som mangler i forbindelse med sygdommen MPS I.
English: Unopened vials: 3 years
Danish: Uåbnede hætteglas: 3 år
English: They accumulate in many tissues in the body, which causes the symptoms of MPS I.
Danish: De samler sig i vævet i store dele af kroppen, hvilket giver symptomerne på MPS I.
English: Aldurazyme should not be mixed with other medicinal products in the same infusion.
Danish: Aldurazyme bør ikke blandes med andre lægemidler i samme infusion.
English: There was a rapid reduction in the excretion of urinary GAG (µg/mg creatinine) within the first 4 weeks, which was maintained through the remainder of the study.
Danish: Der var en hurtig reduktion i udskillelsen af GAG i urinen (µg/mg kreatinin) inden for de første 4 uger, som blev opretholdt i hele den resterende del af studiet.
English: Apnea/Hypopnea Index (AHI)
Danish: Apnø/hypopnø-indeks (AHI)
English: The type of IARs was similar to those seen in other clinical studies.
Danish: Typen af IAR'er svarede til den, der blev observeret i andre kliniske studier.
English: It is given to treat the non-neurological manifestations of the disease.
Danish: Det gives til behandling af de ikke-neurologiske symptomer på sygdommen.
English: The mean urinary GAG level declined by 50% at Week 13 and was reduced by 61% at the end of the study.
Danish: Det gennemsnitlige GAG-niveau i urin faldt med 50% ved uge 13 og var reduceret med 61% ved studiets afslutning.
English: In addition 60 patients in the Phase 2 and 3 studies were tested for in-vitro neutralising effects.
Danish: Desuden blev 60 patienter i fase 2- og fase 3-studierne testet for in-vitro neutraliserende virkning.
English: Laronidase may be excreted in milk.
Danish: Laronidase kan udskilles i mælk.
English: The activity unit (U) is defined as the hydrolysis of one micromole of substrate (4-MUI) per minute.
Danish: Den aktive enhed (E) defineres som hydrolysen af én mikromol substrat (4-MUI) pr. minut.
English: The number of these reactions decreased the longer that patients were on Aldurazyme.
Danish: Antallet af disse reaktioner faldt, jo længere tid patienterne var i behandling med Aldurazyme.
English: Phase 3, 26 weeks of treatment compared to placebo p value Confidence interval
Danish: Fase 3, 26 ugers behandling - sammenlignet med placebo p-værdi
English: 1105 BP Amsterdam The Netherlands
Danish: 1105 BP Amsterdam Holland
English: If you are allergic (hypersensitive) to laronidase or any of the other ingredients of this medicine (listed in section 6).
Danish: Hvis du er allergisk over for laronidase eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: The pharmacokinetic profile in patients less than 5 years old was similar to that of older and less severely affected patients.
Danish: Den farmakokinetiske profil hos patienter under 5 år var sammenlignelig med den hos ældre og mindre alvorligt afficerede patienter.
English: The clinical significance of this finding is unknown since there were no consistent relationships between IgG antibody level and clinical efficacy endpoints.
Danish: Den kliniske betydning af dette fund kendes ikke, da der ikke var nogen konsekvente forbindelser mellem IgG-antistofniveauet og de kliniske effekt-endpoints.
English: Renal elimination of laronidase is considered to be a minor pathway for clearance (see section 4.2).
Danish: Renal elimination af laronidase anses for at være en mindre betydelig clearance-bane (se pkt.
English: The frequency of severe allergic reaction (anaphylactic reaction) and swelling of the face is considered common and may affect up to 1 in 10 people.
Danish: Hyppigheden af alvorlige allergiske reaktioner (anafylaktisk reaktion) og hævelse af ansigtet anses for almindelig og kan ramme op til 1 ud af 10 personer.
English: If not used immediately, in-use storage should not be longer than 24 hours at 2°C - 8°C provided that dilution has taken place under controlled and validated aseptic conditions.
Danish: Hvis det ikke anvendes med det samme, må det ikke opbevares mere end 24 timer ved 2 °C - 8 °C, forudsat at fortyndingen er sket under kontrollerede og validerede aseptiske betingelser.
English: The rationale for enzyme replacement therapy is to restore a level of enzymatic activity sufficient to hydrolyse the accumulated substrate and to prevent further accumulation.
Danish: Baggrunden for enzymerstatningsterapi er at genoprette et niveau for enzym-aktivitet, der er tilstrækkeligt til at hydrolysere det akkumulerede substrat og forhindre yderligere akkumulering.
English: The open label extension study showed improvement and/or maintenance of these effects up to 208 weeks in the Aldurazyme/Aldurazyme group and 182 weeks in the Placebo/Aldurazyme group as indicated in the table below.
Danish: Den åbne forlængelsesstudie viste forbedring og/eller opretholdelse af disse virkninger i op til 208 uger i gruppen på Aldurazyme/Aldurazyme og 182 uger i gruppen på placebo/Aldurazyme, som vist i nedenstående tabel.
English: Animal studies do not indicate direct or indirect harmful effects on pregnancy, embryonal/foetal development, parturition and postnatal development (see section 5.3).
Danish: Dyrestudier viser ikke direkte eller indirekte skadelige virkninger på graviditet, fostrets udvikling, fødsel og den postnatale udvikling (se pkt.
English: Aldurazyme/Aldurazyme Placebo/Aldurazyme At 208 weeks
Danish: Aldurazyme/Aldurazyme Placebo/Aldurazyme Efter 208 uger
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.
Danish: Der blev optaget patienter med en FVC (Forced Vital Capacity) på under 80% af den forventede værdi, og som kunne stå i 6 minutter og gå 5 meter.
English: As there is little experience on resumption of treatment following prolonged interruption, use caution due to the theoretical increased risk of hypersensitivity reaction after treatment interruption.
Danish: Da der kun er få erfaringer ved genoptagelse af behandling efter længerevarende afbrydelse, skal der udvises forsigtighed på grund af den teoretisk forøgede risiko for overfølsomhedsreaktion efter afbrydelse af behandlingen.
English: These reactions may be particularly severe if you have a pre-existing MPS I-related upper airway obstruction.
Danish: Disse reaktioner kan være særligt alvorlige, hvis du i forvejen har en MPS I-relateret tillukning i de øvre luftveje.
English: Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Danish: Genzyme Irland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Irland
English: Talk to your doctor before using Aldurazyme.
Danish: Tal med din læge, før du får Aldurazyme.
English: Pharmacotherapeutic group: Enzymes.
Danish: Farmakoterapeutisk klassifikation: enzymer.
English: Several patients showed an increase in height (n=7) and weight (n=3) for age Z-score.
Danish: Adskillige patienter udviste en stigning i højde (n=7) og vægt (n=3) for alders-Z-score.
English: Percent Predicted FVC (percentage point)
Danish: Procent forventet FVC (procentpoint)