FrancophonIA/ELRC3.0 huggingface dataset:
English: Limited information from clinical trials suggests that the safety profile of Fabrazyme treatment in paediatric patients ages 5-7, treated with either 0.5 mg/kg every 2 weeks or 1.0 mg/kg every 4 weeks is similar to that of patients (above the age of 7) treated at 1.0 mg/kg every 2 weeks.
Danish: Begrænsede data fra kliniske studier tyder på, at Fabrazymes sikkerhedsprofil hos børn i alderen 57 år, som får enten 0,5 mg/kg hver 2. uge eller 1,0 mg/kg hver 4. uge, er den samme som hos patienter (over 7 år), som får 1,0 mg/kg hver 2. uge.
English: EU/1/01/188/001 Fabrazyme 35 mg 1 vial of powder for concentrate for solution for infusion EU/1/01/188/002 Fabrazyme 35 mg 5 vials of powder for concentrate for solution for infusion EU/1/01/188/003 Fabrazyme 35 mg 10 vials of powder for concentrate for solution for infusion EU/1/01/188/004 Fabrazyme 5 mg 1 vial of powder for concentrate for solution for infusion EU/1/01/188/005 Fabrazyme 5 mg 5 vials of powder for concentrate for solution for infusion EU/1/01/188/006 Fabrazyme 5 mg 10 vials of powder for concentrate for solution for infusion
Danish: EU/1/01/188/001 Fabrazyme 35 mg 1 hætteglas pulver til koncentrat til infusionsvæske, opløsning EU/1/01/188/002 Fabrazyme 35 mg 5 hætteglas pulver til koncentrat til infusionsvæske, opløsning EU/1/01/188/003 Fabrazyme 35 mg 10 hætteglas pulver til koncentrat til infusionsvæske, opløsning EU/1/01/188/004 Fabrazyme 5 mg 1 hætteglas pulver til koncentrat til infusionsvæske, opløsning EU/1/01/188/005 Fabrazyme 5 mg 5 hætteglas pulver til koncentrat til infusionsvæske, opløsning EU/1/01/188/006 Fabrazyme 5 mg 10 hætteglas pulver til koncentrat til infusionsvæske, opløsning
English: 1105 BP Amsterdam The Netherlands
Danish: Paasheuvelweg 25 1105 BP Amsterdam Holland
English: • low heart rate due to conduction disturbances
Danish: • langsom hjerterytme (puls) pga. forstyrrelse i reguleringen af hjertet
English: Before further dilution, visually inspect the reconstituted solution in each vial for particulate matter and discoloration.
Danish: Før yderligere fortynding efterses det rekonstituerede koncentrat i hvert hætteglas for partikler og misfarvning.
English: Life threatening hypersensitivity (anaphylactic reaction) to the active substance or any of the excipients listed in section 6.1.
Danish: Livstruende overfølsomhed (anafylaktisk reaktion) over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: Marketing Authorisation Holder and Manufacturer Marketing authorisation holder
Danish: Indehaver af markedsføringstilladelsen og fremstiller Indehaver af markedsføringstilladelsen
English: • increased sensitivity to pain
Danish: • forhøjet smertefølelse
English: The recommended dose of Fabrazyme for children and adolescents 8 - 16 years is 1 mg/kg body weight, once every 2 weeks.
Danish: Den anbefalede dosis Fabrazyme til børn og unge fra 8 til 16 år er 1 mg/kg kropsvægt, én gang hver 14. dag.
English: Slowly, withdraw 7.0 ml (equal to 35 mg) of the reconstituted solution from each vial up to the total volume required for the patient dose.
Danish: Træk langsomt 7,0 ml (svarende til 35 mg) rekonstitueret koncentrat ud fra hvert hætteglas op til det totale volumen, der er nødvendigt til patientens dosis.
English: Baseline CL was 77 ml/min with a Vss of 2.6 l; half-life was 55 min. After IgG seroconversion, CL decreased to 35 ml/min, Vss increased to 5.4 l, and half-life increased to 240 min.
Danish: Baseline-CL var 77 ml/min med et Vss på 2,6 l; halveringstiden var 55 minutter.
English: Studies have not been conducted to assess the potential effects of Fabrazyme on impairment of fertility.
Danish: Fertilitet Der er ikke foretaget undersøgelser til vurdering af Fabrazymes potentielle virkninger på fertiliteten.
English: • Home infusion manuals for patients
Danish: • Manualer til patienter vedr.
English: Any unused solution should be discarded.
Danish: Ikke anvendt infusionsvæske skal destrueres.
English: After reconstitution with 7.2 ml water for injections, each vial of Fabrazyme contains 5 mg/ml (35 mg/7 ml) of agalsidase beta.
Danish: Efter fortynding med 7,2 ml injektionsvæske indeholder hvert hætteglas Fabrazyme 5 mg/ml (35 mg/7ml) agalsidase beta.
English: Very common adverse reactions included chills, pyrexia, feeling cold, nausea, vomiting, headache and paraesthesia.
Danish: Meget almindelige bivirkninger omfattede kulderystelser, pyreksi, kuldefornemmelse, kvalme, opkastning, hovedpine og paræstesi.
English: Tell your doctor if you use any medicines containing chloroquine, amiodarone, benoquin or gentamicin.
Danish: Fortæl det til lægen, hvis du bruger lægemidler, der indeholder chloroquin, amiodaron, benoquin eller gentamicin, da der er en teoretisk risiko for, at agalsidase beta virker dårligere.
English: • malaise
Danish: • ubehag
English: Do not invert, swirl or shake the vial.
Danish: Vend ikke hætteglasset på hovedet, og hvirvl eller ryst det ikke.
English: Excipients: mannitol sodium phosphate monobasic, monohydrate sodium phosphate dibasic, heptahydrate See the leaflet for further information.
Danish: Hjælpestoffer: mannitol natriumdihydrogenphosphatmonohydrat dinatriumphosphatheptahydrat Se indlægssedlen for yderligere oplysninger.
English: • fast breathing
Danish: • hurtig vejrtrækning
English: The recommended dose of Fabrazyme for adults is 1 mg/kg body weight, once every 2 weeks.
Danish: Den anbefalede dosis Fabrazyme til voksne er 1 mg/kg kropsvægt én gang hver 14. dag.
English: Use of Fabrazyme during breastfeeding is not recommended.
Danish: Anvendelse af Fabrazyme under amning kan ikke anbefales.
English: • infusion site reaction
Danish: • reaktion ved indgivelsesstedet
English: Agalsidase beta clearance was not influenced by weight in this population.
Danish: Vægten påvirkede ikke clearance (CL) af agalsidase beta i denne gruppe.
English: The powder for concentrate for solution for infusion has to be reconstituted with water for injections, diluted with 0.9% sodium chloride intravenous solution and then administered by intravenous infusion.
Danish: Pulver til koncentrat til infusionsvæske, opløsning skal rekonstitueres med vand til injektionsvæsker, fortyndes i 0,9 % intravenøs natriumchlorid-infusionsvæske og administreres ved intravenøs infusion.
English: Genzyme Europe B.V. Paasheuvelweg 25
Danish: Genzyme Europe B.V.
English: - The need to seek urgent treatment in the event of failure to gain venous access or if there is a lack of efficacy - The need to keep a diary to document each treatment received at home and to bring it at each visit
Danish: - Behovet for at føre dagbog for at dokumentere hver enkelt behandling modtaget i hjemmet og medbringe denne ved hver konsultation.
English: Investigations oxygen saturation decreased
Danish: Nedsat oxygenm ætning
English: Gently invert or lightly massage the infusion bag to mix the diluted solution.
Danish: Vend forsigtigt infusionsposen eller masser den let for at blande infusionsvæsken.
English: Hepatic impairment Studies in patients with hepatic insufficiency have not been performed.
Danish: Nedsat leverfunktion Der er ikke udført undersøgelser hos patienter med leverinsufficiens.
English: Fabrazyme is indicated for use as long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease.
Danish: Fabrazyme er indiceret til langtids-enzymerstatningsbehandling hos patienter, hvor diagnosen Fabrys sygdom er bekræftet
English: EU/1/01/188/001 1 vial of powder for concentrate for solution for infusion EU/1/01/188/002 5 vials of powder for concentrate for solution for infusion EU/1/01/188/003 10 vials of powder for concentrate for solution for infusion
Danish: EU/1/01/188/001 1 hætteglas pulver til koncentrat til infusionsvæske, opløsning EU/1/01/188/002 5 hætteglas pulver til koncentrat til infusionsvæske, opløsning EU/1/01/188/00310 hætteglas pulver til koncentrat til infusionsvæske, opløsning
English: This is done by slow dropwise addition of the water for injection down the inside of the vial and not directly onto the lyophilized cake.
Danish: Dette foregår ved at tilsætte vand til injektionsvæsker drypvist ned langs indersiden af hætteglasset og ikke direkte ned på den lyofiliserede substans.
English: EU/1/01/188/004 1 vial of powder for concentrate for solution for infusion EU/1/01/188/005 5 vials of powder for concentrate for solution for infusion EU/1/01/188/006 10 vials of powder for concentrate for solution for infusion
Danish: EU/1/01/188/004 1 hætteglas pulver til koncentrat til infusionsvæske, opløsning EU/1/01/188/005 5 hætteglas pulver til koncentrat til infusionsvæske, opløsning EU/1/01/188/006 10 hætteglas pulver til koncentrat til infusionsvæske, opløsning
English: SN:
Danish: PC: SN:
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på de fremstillere, der er ansvarlige for batchfrigivelse Genzyme Ireland Limited
English: • abnormal tear secretion • rash
Danish: • unormal tåreproduktion • udslæt
English: • Home infusion manual for healthcare professionals
Danish: • Manual til sundhedspersonale vedr.
English: How to use Fabrazyme
Danish: Sådan skal du bruge Fabrazyme
English: This is done by slow drop-wise addition of the water for injection down the inside of the vial and not directly onto the lyophilized cake.
Danish: Dette foregår ved forsigtigt at tilsætte vand til injektionsvæsker drypvist ned langs indersiden af hætteglasset og ikke direkte ned på den lyofiliserede substans.
English: After reconstitution with 1.1 ml water for injections, each vial of Fabrazyme contains 5 mg/ml of agalsidase beta.
Danish: Efter fortynding med 1,1 ml injektionsvæske indeholder hvert hætteglas Fabrazyme 5 mg/ml agalsidase beta.
English: • Periodic safety update reports (PSURs)
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: One vial of powder contains 5 mg of agalsidase beta.
Danish: Et hætteglas med pulver indeholder 5 mg agalsidase beta
English: Fabrazyme 35 mg powder for concentrate for solution for infusion Fabrazyme 35 mg is supplied in clear Type I glass 20 ml vials.
Danish: Fabrazyme 35 mg pulver til koncentrat til infusionsvæske, opløsning Fabrazyme 35 mg leveres i klare type I 20 ml hætteglas.
English: Package leaflet: Information for the user Fabrazyme 5 mg powder for concentrate for solution for infusion
Danish: Indlægsseddel: Information til brugeren Fabrazyme 5 mg pulver til koncentrat til infusionsvæske, opløsning
English: • (mottled purplish) skin discoloration
Danish: • hud ubehag • (rødprikket) misfarvning af huden
English: One vial of powder contains 35 mg of agalsidase beta.
Danish: Et hætteglas med pulver indeholder 35 mg agalsidase beta
English: Package leaflet: Information for the user Fabrazyme 35 mg powder for concentrate for solution for infusion
Danish: Indlægsseddel: Information til brugeren Fabrazyme 35 mg pulver til koncentrat til infusionsvæske, opløsning
English: Gastrointestinal Disorders nausea, vomiting abdominal pain, abdominal pain upper, abdominal discomfort, stomach discomfort, hypoaesthesia oral, diarrhoea dyspepsia, dysphagia --
Danish: Abdominalsmerter, smerter i øvre abdomen, abdominale gener oral hypæstesi, diarré
English: Do not shake or excessively agitate the infusion bag.
Danish: Ryst ikke infusionsposen og bevæg den ikke voldsomt.
English: Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate
Danish: Natriumdihydrogenphosphatmonohydrat Dinatriumphosphatheptahydrat
English: • upper respiratory tract congestion
Danish: • tilstoppelse i øvre luftveje
English: • chest discomfort
Danish: • hud ubehag
English: • difficulty in breathing
Danish: • vejrtrækningsproblemer
English: Fabrazyme 35 mg powder for concentrate for solution for infusion Fabrazyme 5 mg powder for concentrate for solution for infusion
Danish: Fabrazyme 35 mg pulver til koncentrat til infusionsvæske, opløsning Fabrazyme 5 mg pulver til koncentrat til infusionsvæske, opløsning
English: The level of support required for home infusion will be discussed and agreed by the patient and/or caregiver with the prescribing physician.
Danish: Den ordinerende læge gennemgår og aftaler den nødvendige støtte i forbindelse med hjemmebehandling med patienten og/eller plejepersonalet.
English: Musculoskeletal and connective tissue disorders pain in extremity, myalgia, back pain, muscle spasms, arthralgia, muscle tightness, musculoskeletal stiffness musculoskeletal pain --
Danish: Smerter i ekstremiteter, myalgi, rygsmerter, muskelspasmer , artralgi, muskelspændin ger, stivhed i bevægeapparat et
English: • itching eyes
Danish: • kløende øjne
English: Prior to adding the reconstituted volume of Fabrazyme required for the patient dose, it is recommended to remove an equal volume of 0.9% sodium chloride intravenous solution, from the infusion bag.
Danish: Før tilsætning af det volumen af det rekonstituerede koncentrat, som er nødvendigt til patientens Fabrazyme-dosis, anbefales det at fjerne et tilsvarende volumen 0,9 % natriumchloridinfusionsvæske fra infusionsposen.
English: • increased blood pressure • joint pain
Danish: • forhøjet blodtryk
English: Fabrazyme 35 mg powder for concentrate for solution for infusion Prior to adding the reconstituted volume of Fabrazyme required for the patient dose, it is recommended to remove an equal volume of 0.9% sodium chloride intravenous solution, from the infusion bag.
Danish: Fabrazyme 35 mg pulver til koncentrat til infusionsvæske, opløsning Før tilsætning af det volumen af det rekonstituerede koncentrat, som er nødvendigt til patientens Fabrazyme-dosis, anbefales det at fjerne et tilsvarende volumen 0,9 % natriumchlorid-infusionsvæske fra infusionsposen.
English: Nervous system disorders headache, paraesthesia dizziness, somnolence, hypoaesthesia, burning sensation, lethargy, syncope hyperaesthesia, tremor
Danish: Svimmelhed, døsighed, hypæstesi, brændende fornemmelse, letargi, synkope
English: Fabrazyme 5 mg powder for concentrate for solution for infusion Prior to adding the reconstituted volume of Fabrazyme required for the patient dose, it is recommended to remove an equal volume of 0.9% sodium chloride intravenous solution, from the infusion bag.
Danish: Fabrazyme 5 mg pulver til koncentrat til infusionsvæske, opløsning Før tilsætning af det volumen af det rekonstituerede koncentrat, som er nødvendigt til patientens Fabrazyme-dosis, anbefales det at fjerne et tilsvarende volumen 0,9 % natriumchlorid-infusionsvæske fra infusionsposen.
English: Fabrazyme 5 mg powder for concentrate for solution for infusion Fabrazyme 5 mg is supplied in clear Type I glass 5 ml vials.
Danish: Fabrazyme 5 mg pulver til koncentrat til infusionsvæske, opløsning Fabrazyme 5 mg leveres i klare type I 5 ml hætteglas.
English: • exacerbated difficulty in breathing
Danish: • øgede vejrtræknings problemer
English: Fabrazyme 35 mg powder for concentrate for solution for infusion Each vial of Fabrazyme contains a nominal value of 35 mg of agalsidase beta.
Danish: Fabrazyme 35 mg pulver til koncentrat til infusionsvæske, opløsning Hvert hætteglas med Fabrazyme indeholder et deklareret indhold på 35 mg agalsidase beta.
English: Sanofi S.p.A. Tel: +39 02 39394275
Danish: Tel: +39 02 39394275
English: • lower blood oxygen levels • serious inflammation of the vessels
Danish: • Lavere niveauer af oxygen (ilt)
English: • red rash
Danish: • rødt udslæt
English: • musculoskeletal stiffness
Danish: • muskelkramper
English: Fabrazyme 5 mg powder for concentrate for solution for infusion Each vial of Fabrazyme contains a nominal value of 5 mg of agalsidase beta.
Danish: Fabrazyme 5 mg pulver til koncentrat til infusionsvæske, opløsning Hvert hætteglas med Fabrazyme indeholder et deklareret indhold på 5 mg agalsidase beta.
English: For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Danish: Opbevares i køleskab (2 °C - 8 °C) Opbevaringsforhold efter rekonstitution og fortynding af lægemidlet, se pkt.
English: lacrimation increased eye pruritus, ocular hyperaemia
Danish: Øjenkløe, okular hyperæmi
English: 10 vials of powder for concentrate for solution for infusion.
Danish: 10 hætteglas pulver til koncentrat til infusionsvæske, opløsning.
English: If you use more Fabrazyme than you should
Danish: Hvis du har brugt for meget Fabrazyme
English: Fabrazyme 35 mg powder for concentrate for solution for infusion Reconstitute each vial of Fabrazyme 35 mg with 7.2 ml water for injections.
Danish: Fabrazyme 35 mg pulver til koncentrat til infusionsvæske, opløsning Opløs indholdet i hvert hætteglas Fabrazyme 35 mg med 7,2 ml vand til injektionsvæsker; undgå kraftig indvirkning af vand til injektionsvæsker på pulveret og undgå skumdannelse.
English: What Fabrazyme is and what it is used for What you need to know before you use Fabrazyme How to use Fabrazyme
Danish: Det skal du vide, før du begynder at bruge Fabrazyme Sådan skal du bruge Fabrazyme Bivirkninger
English: Fabrazyme 5 mg powder for concentrate for solution for infusion Reconstitute each vial of Fabrazyme 5 mg with 1.1 ml water for injections.
Danish: Fabrazyme 5 mg pulver til koncentrat til infusionsvæske, opløsning Opløs indholdet i hvert hætteglas Fabrazyme 5 mg med 1,1 ml vand til injektionsvæsker; undgå kraftig indvirkning af vand til injektionsvæsker på pulveret og undgå skumdannelse.
English: Vascular disorders flushing, hypertension, pallor, hypotension, hot flush peripheral coldness --
Danish: Rødmen, hypertension, bleghed, hypotension, hedeture
English: • influenza-like illness
Danish: • søvnlignende sløvhedstilstand
English: 5 vials of powder for concentrate for solution for infusion.
Danish: 5 hætteglas pulver til koncentrat til infusionsvæske, opløsning.
English: • urticaria
Danish: Fortynding
English: Genzyme Europe B.V.- NL Store in a refrigerator (2°C - 8°C)
Danish: - NL Opbevares i køleskab (2 °C - 8 °C).
English: Renal impairment
Danish: Tinnitus, svimmelhed
English: Immune system disorders anaphylactoid reaction
Danish: Dyspepsi Dysfagi
English: Respiratory, thoracic and mediastinal disorders dyspnoea, nasal congestion, throat tightness, wheezing, cough, dyspnoea exacerbated bronchospasm, pharyngolaryngeal pain, rhinnorhoea, tachypnoea, upper respiratory tract congestion hypoxia
Danish: Bronkospasmer faryngolarynge ale smerter, rinoré, takypnø, kongestion af øvre luftveje hypoksi
English: Infections and infestations nasopharyngitis rhinitis
Danish: Luftveje thorax og mediastinum
English: • injection site blood clotting
Danish: • blodstørkning ved indgivelsesstedet
English: • nasal congestion
Danish: • næseflåd
English: There is a theoretical risk of decreased agalsidase beta activity.
Danish: - Aktivt stof: agalsidase beta.
English: Skin and subcutaneous tissue disorders pruritus, urticaria, rash, erythema, pruritus generalized, angioneurotic oedema, swelling face, rash maculo-papular livedo reticularis, rash erythematous, rash pruritic, skin discolouration, skin discomfort leukocytoclastic vasculitis
Danish: Pruritus, urticaria, udslæt, hudrødmen, generaliseret pruritus, angioødem, ansigtshævelse, makulopapuløs t udslæt
English: • fatigue
Danish: • bleghed
English: • wheezing
Danish: • kløen
English: Fabrazyme 5 mg powder for concentrate for solution for infusion agalsidase beta
Danish: Fabrazyme 5 mg pulver til koncentrat til infusionsvæske, opløsning.
English: Reconstitute each vial of Fabrazyme 35 mg with 7.2 ml water for injections.
Danish: Opløs indholdet i hvert hætteglas Fabrazyme 35 mg med 7,2 ml vand til injektionsvæsker; undgå kraftig indvirkning af vand til injektionsvæsker på pulveret og bland forsigtigt for at undgå skumdannelse.
English: • feeling hot
Danish: • varmefølelse
English: - The active substance is agalsidase beta, one vial contains 5 mg. - The other ingredients are:
Danish: - Aktivt stof: agalsidase beta, 1 hætteglas indeholder 5 mg. - Øvrige indholdsstoffer: - Mannitol - Natriumdihydrogenphosphatmonohydrat - Dinatriumphosphatheptahydrat
English: • redness
Danish: • hedeture
English: Fabrazyme 35 mg powder for concentrate for solution for infusion agalsidase beta
Danish: Fabrazyme 35 mg pulver til koncentrat til infusionsvæske, opløsning.
English: • abdominal discomfort
Danish: • utilpashed i underlivet
English: • runny nose
Danish: • tilstoppet næse
English: • dizziness
Danish: • hudrødme
English: • flushing
Danish: • halsbrand
English: 1 vial of powder for concentrate for solution for infusion.
Danish: 1 hætteglas pulver til koncentrat til infusionsvæske, opløsning.
English: Reconstitute each vial of Fabrazyme 5 mg with 1.1 ml water for injections.
Danish: Opløs indholdet i hvert hætteglas Fabrazyme 5 mg med 1,1 ml vand til injektionsvæsker; undgå kraftig indvirkning af vand til injektionsvæsker på pulveret og bland forsigtigt for at undgå skumdannelse.
English: • low heart rate
Danish: • sænket hjerterytme
English: • musculoskeletal pain
Danish: • kramper i lungeområdet
English: • heart burn
Danish: • hjertebanken
English: Genzyme Ireland Limited IDA Industrial Park Old Kilmeaden Road Waterford
Danish: Old Kilmeaden Road
English: • increased heart beat
Danish: • hurtigere hjerterytme (puls)
English: Dilution
Danish: Amning
English: • throat pain
Danish: • strammen i halsen
English: • nasopharyngitis
Danish: • ørepine
English: Older people (≥ 65 years)
Danish: Ældre (≥ 65 år)
English: A summary of results is presented in Table 3.
Danish: Et resumé af resultaterne er præsenteret i tabel 3.
English: The duration of the trial was one year.
Danish: Varigheden af forsøget var 1 år.
English: Your doctor will let you know when to return for your next dose.
Danish: Din læge vil fortælle dig, hvornår du skal komme tilbage og få din næste dosis.
English: Component of a multipack, can't be sold separately.
Danish: Del af en multipakning, kan ikke sælges separat.
English: Both cases resolved.
Danish: I begge tilfælde er det forsvundet.
English: Swelling and/or pain at the infusion site may occur.
Danish: Hævelse og/eller smerte ved infusionsstedet kan forekomme.
English: Five of the 6 patients had SAP within the normal range at month 6 (Last Observation Carried Forward, LOCF).
Danish: Fem af de 6 patienter havde SAP inden for normalområdet ved måned 6 (Last Observation Carried Forward, LOCF).
English: Effect on height
Danish: Effekt på højde
English: The educational programme contains the following:
Danish: Uddannelsesprogrammet indeholder følgende:
English: Renal impairment has been observed in patients after a single administration.
Danish: Nedsat nyrefunktion er blevet observeret hos patienter efter en enkelt administration.
English: It comes in a clear plastic bottle.
Danish: Den leveres i gennemsigtige plastikflasker.
English: Tell your dentist immediately if you experience such symptoms.
Danish: Kontakt straks din tandlæge, hvis du oplever sådanne symptomer.
English: • in post-menopausal women
Danish: • hos postmenopausale kvinder
English: While on treatment, these patients should avoid invasive dental procedures if possible.
Danish: Under behandling bør disse patienter om muligt undgå invasiv tandbehandling.
English: This corresponds to a 28% reduction in the risk of all cause mortality (p=0.01).
Danish: Det svarer til en reduktion på 28 % i risikoen for all cause mortalitet (p=0,01).
English: Very common Fever Common
Danish: Meget almindelig Feber
English: All clinical fractures were verified based on the radiographic and/or clinical evidence.
Danish: Alle kliniske frakturer blev verificeret ud fra radiografi og/eller klinisk dokumentation.
English: - After opening the bottle, the product should be used immediately in order to avoid microbial contamination.
Danish: - Efter åbning skal præparatet bruges straks for at undgå mikrobiel forurening.
English: - if you are unable to take daily calcium supplements.
Danish: - hvis du ikke kan tage dagligt kalktilskud.
English: Special populations
Danish: Særlig populationer
English: Over the first 24 hours, 39 ± 16% of the administered dose is recovered in the urine, while the remainder is principally bound to bone tissue.
Danish: I løbet af de første 24 timer findes 39±16 % af den indgivne dosis i urinen, hvorimod den resterende mængde primært er bundet til knoglevævet.