FrancophonIA/ELRC3.0 huggingface dataset:
English: Common: Injection site reactions (e.g. stinging, burning, pain , redness, oedema) Reporting of suspected adverse reactions
Danish: Almindelig: Reaktioner på injektionsstedet (f.eks. brænden, svien, smerte, rødme, ødem) Indberetning af formodede bivirkninger
English: Step 4b: Injecting Relistor using a standard injection syringe and injection needle
Danish: Trin 4b: Injektion af Relistor med en standardinjektionssprøjte og kanyle
English: Each syringe of 0.4 mL contains 8 mg methylnaltrexone bromide.
Danish: Hver sprøjte på 0,4 ml indeholder 8 mg methylnaltrexonbromid.
English: After the needle is inserted, let go of the skin and slowly push the plunger all the way down to inject Relistor.
Danish: Slip huden, når kanylen er inde i huden, og pres langsomt stemplet helt ned for at injicere Relistor.
English: • Vomiting
Danish: • Svimmelhed
English: After the needle is inserted, let go of the skin and slowly push the plunger all the way down until the pre-filled syringe is empty.
Danish: Slip huden, når kanylen er inde i huden, og pres langsomt stemplet helt ned, indtil den fyldte injektionssprøjte er tom.
English: Relistor 8 mg solution for injection in pre-filled syringe Relistor 12 mg solution for injection in pre-filled syringe Methylnaltrexone bromide
Danish: Relistor 8 mg injektionsvæske, opløsning, i fyldt injektionssprøjte Relistor 12 mg injektionsvæske, opløsning, i fyldt injektionssprøjte Methylnaltrexonbromid
English: One mL of solution contains 20 mg methylnaltrexone bromide.
Danish: 1 ml opløsning indeholder 20 mg methylnaltrexonbromid.
English: How to use Relistor
Danish: Sådan skal du bruge Relistor
English: 2 sterile 1 mL injection syringes with retractable injection needle 4 alcohol swabs
Danish: 2 sterile 1 ml-injektionssprøjter med automatisk tilbagetrækning af kanylen 4 spritservietter
English: Common: opioid-withdrawal-like symptoms (like chills, tremor, rhinorrhea, piloerection, hot flush, palpitation, hyperhidrosis, vomiting, abdominal pain)
Danish: Almindelig: Opioid-seponeringslignende symptomer (såsom kulderystelser, tremor, rhinorrhea, piloarrektion, hedeture, palpitationer, hyperhidrose, opkastning, mavesmerter)
English: Step 4a: Injecting Relistor using a pack containing injection syringe with retractable injection needle
Danish: Trin 4a: Injektion af Relistor med injektionssprøjte med automatisk tilbagetrækning af kanylen
English: To prepare the area of skin where Relistor is to be injected, wipe the injection site with an alcohol swab.
Danish: Tør injektionsstedet af med spritservietten for at forberede det område af huden, hvor Relistor skal injiceres.
English: Relistor pre-filled syringe Alcohol swab Cotton ball or gauze Adhesive plaster
Danish: Et stykke vat eller gazebind Hæfteplaster
English: Relistor is a solution for injection.
Danish: Relistor er en injektionsvæske, opløsning.
English: 7 sterile 1 mL injection syringes with retractable injection needle 14 alcohol swabs
Danish: 7 sterile 1 ml-injektionssprøjter med automatisk tilbagetrækning af kanylen 14 spritservietter
English: 2 vials of 0.6 mL
Danish: 2 hætteglas à 0,6 ml
English: The recommended dose for patients receiving supportive care for advanced illness is 8 mg methylnaltrexone bromide (0.4 mL of solution) for patients weighing 38-61 kg or 12 mg (0.6 mL of solution) for patients weighing 62-114 kg.
Danish: Den anbefalede dosis til patienter, der får understøttende behandling for fremskreden sygdom, er 8 mg methylnaltrexonbromid (0,4 ml injektionsvæske) til patienter, der vejer 38-61 kg, eller 12 mg (0,6 ml injektionsvæske) til patienter, der vejer 62-114 kg.
English: If you have suffered from constipation before you had to take opioids (for pain), please talk to your doctor.
Danish: Du bedes tale med din læge, hvis du led af forstoppelse, før du var nødt til at tage opioider (mod smerte).
English: - The other ingredients are sodium chloride, sodium calcium edetate, glycine hydrochloride, water for injections, hydrochloric acid (to adjust pH) and sodium hydroxide (to adjust pH).
Danish: - Øvrige indholdsstoffer: natriumklorid, natriumcalciumedetat, glycinhydroklorid, vand til injektion, saltsyre (til justering af pH) og natriumhydroxid (til justering af pH).
English: Keep the needle attached to the syringe.
Danish: Lad kanylen sidde på sprøjten.
English: In addition, median daily opioid dose did not vary meaningfully from baseline in either methylnaltrexone bromide-treated patients or in placebotreated patients.
Danish: Endvidere var den gennemsnitlige daglige opioiddosis ikke væsentligt forskellig i forhold til baseline for hverken patienter behandlet med methylnaltrexonbromid eller patienter behandlet med placebo.
English: Sodium chloride, sodium calcium edetate, glycine hydrochloride, water for injections, hydrochloric acid (to adjust pH), sodium hydroxide (to adjust pH).
Danish: Natriumklorid, natriumcalciumedetat, glycinhydroklorid, vand til injektion, saltsyre (til justering af pH), natriumhydroxid (til justering af pH).
English: Opioid withdrawal
Danish: Opioidabstinenser
English: Step 3: Injecting Relistor pre-filled syringe
Danish: Trin 3: Injektion af Relistor i fyldt injektionssprøjte 1.
English: Each syringe of 0.6 mL contains 12 mg methylnaltrexone bromide.
Danish: Hver sprøjte på 0,6 ml indeholder 12 mg methylnaltrexonbromid.
English: Make sure the solution in the vial is clear and colourless to pale yellow, and does not contain flakes or particles.
Danish: Kontrollér, at opløsningen i hætteglasset er klar og farveløs til svagt gul og ikke indeholder flager eller partikler.
English: Each vial contains 0.6 mL of solution.
Danish: Hvert hætteglas indeholder 0,6 ml opløsning.
English: Median daily opioid dose did not vary meaningfully from baseline in either methylnaltrexone bromide-treated patients or in placebo-treated patients.
Danish: Den mediane daglige opioiddosis ved baseline varierede ikke væsentligt hos hverken patienter behandlet med methylnaltrexonbromid eller patienter behandlet med placebo.
English: The first co-primary endpoint was the proportion of patients having a rescue free bowel movements (RFBMs) within 4 hours of the first dose administration and the second the percentage of active injections resulting in any RFBM within 4 hours during the double-blind phase.
Danish: Det ene primære endepunkt var andelen af patienter, der havde afføring uden behovsmedicin inden for 4 timer efter administration af den første dosis, og det andet primære endepunkt var procentdelen af aktive injektioner, der resulterede i afføring uden behovsmedicin inden for 4 timer under den dobbeltblindede fase.
English: In patients with severe renal impairment (creatinine clearance less than 30 mL/min), the dose of methylnaltrexone bromide should be reduced from 12 mg to 8 mg (0.4 mL of solution) for those weighing 62 to 114 kg.
Danish: Til patienter med svært nedsat nyrefunktion (kreatinin-clearance mindre end 30 ml/min) skal dosen af methylnaltrexonbromid reduceres fra 12 mg til 8 mg (0,4 ml opløsning) til patienter, der vejer fra 62 til 114 kg. Til patienter med svært nedsat nyrefunktion, hvis vægt ligger uden for intervallet 62 til 114 kg (se pkt.
English: If you use more Relistor than you should
Danish: Hvis du har brugt for meget Relistor
English: Common: opioid-withdrawal-like symptoms (like chills, tremor, rhinorrhea, piloerection, hot flush, palpitation, hyperhidrosis, vomiting, abdominal pain) Gastrointestinal disorders
Danish: Almindelig: Opioid-seponeringslignende symptomer (såsom kulderystelser, tremor, rhinorrhea, piloarrektion, hedeture, palpitationer, hyperhidrose, opkastning, mavesmerter) Mave-tarmkanalen
English: NAME OF THE MEDICINAL PRODUCT Relistor 8 mg solution for injection in pre-filled syringe
Danish: LÆGEMIDLETS NAVN Relistor 8 mg injektionsvæske, opløsning, i fyldt injektionssprøjte
English: NAME OF THE MEDICINAL PRODUCT Relistor 12 mg/0.6 mL solution for injection
Danish: LÆGEMIDLETS NAVN Relistor 12 mg/0,6 ml injektionsvæske, opløsning.
English: Subcutaneous injections of Relistor at 150/100 mg/kg/day to rats resulted in decreased offspring weights; doses up to 25 mg/kg/day (18 times the exposure [AUC] in humans at a subcutaneous dose of 0.3 mg/kg) had no effect on labour, delivery, or offspring survival and growth.
Danish: Doser på op til 25 mg/kg/dag (18 gange eksponeringen [AUC] hos mennesker i en subkutan dosis på 0,3 mg/kg) påvirkede ikke fødsel, nedkomst eller afkommets vækst og overlevelse.
English: Hold the barrel of the syringe with one hand and pull the needle cover straight off. Place the needle cover back on the work surface.
Danish: Hold sprøjtens rør med den ene hånd og træk kanylehætten lige af.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe of 0.4 mL contains 8 mg of methylnaltrexone bromide.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver fyldte injektionssprøjte på 0,4 ml indeholder 8 mg methylnaltrexonbromid.
English: Each pre-filled syringe contains 0.4 mL of solution for injection.
Danish: Hver fyldte injektionssprøjte indeholder 0,4 ml injektionsvæske, opløsning.
English: When the syringe is empty, quickly pull the needle out of the skin, being careful to keep it at the same angle as inserted.
Danish: Når sprøjten er tom, trækkes kanylen hurtigt ud af huden, idet den holdes i den samme vinkel, som da den blev ført ind. Der kan forekomme en mindre blødning på injektionsstedet.
English: Pack sizes of 1 vial,
Danish: Pakningsstørrelse med:
English: 2 vials with 2 sterile 1 mL injection syringes with retractable injection needle and 4 alcohol swabs; or 7 vials with 7 sterile 1 mL injection syringes with retractable injection needle and 14 alcohol swabs.
Danish: 2 hætteglas med 2 sterile 1 ml-injektionssprøjter med automatisk tilbagetrækning af kanylen og 4 spritservietter; eller
English: There were no clinically relevant changes from baseline in pain scores in either the methylnaltrexone bromide or placebo-treated patients.
Danish: Der var ingen klinisk relevante ændringer fra baseline i smertescore hverken hos patienter behandlet med methylnaltrexonbromid eller med placebo.
English: Gastrointestinal (GI) conditions and GI perforation Methylnaltrexone bromide should be used with caution in patients with known or suspected lesions of the GI tract.
Danish: Methylnaltrexonbromid skal anvendes med forsigtighed til patienter med læsioner, eller hos hvem der er mistanke om læsioner i mave-tarm-kanalen.
English: • Opioid-withdrawal-like symptoms (any of the following: feeling cold, shivering, runny nose,
Danish: • Symptomer som ved ophør med opioidbehandling (en eller flere af følgende: Kuldefølelse, skælven, løbenæse, sveden, gåsehud, rødme, hurtig puls)
English: • If you develop severe or persistent diarrhoea (passing of frequent watery stools), discontinue therapy and contact your doctor immediately.
Danish: • Hvis du får svær eller vedvarende diaré (hyppig, tyndtflydende afføring).
English: There were no clinically relevant changes in pain scores from baseline in either the methylnaltrexone bromide or placebo-treated patients.
Danish: Der var ingen klinisk relevante ændringer i smertescore i forhold til baseline for hverken patienter behandlet med methylnaltrexonbromid eller patienter behandlet med placebo.
English: If unsure, please contact your doctor, nurse or pharmacist.
Danish: Kontakt din sygeplejerske, læge eller apoteket.
English: NAME OF THE MEDICINAL PRODUCT Relistor 12 mg solution for injection in pre-filled syringe
Danish: LÆGEMIDLETS NAVN Relistor 12 mg injektionsvæske, opløsning, i fyldt injektionssprøjte
English: Each pre-filled syringe contains 0.6 mL of solution for injection.
Danish: Hver fyldte injektionssprøjte indeholder 0,6 ml injektionsvæske, opløsning.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection.
Danish: LÆGEMIDDELFORM OG ANTAL (PAKNINGSSTØRRELSE) Injektionsvæske, opløsning.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Relistor 12 mg/0.6 mL solution for injection Methylnaltrexone bromide
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Relistor 12 mg/0,6 ml injektionsvæske, opløsning.
English: The recommended dose of methylnaltrexone bromide is 12 mg (0.6 mL of solution) subcutaneously, as needed, given as at least 4 doses weekly, up to once daily (7 doses weekly).
Danish: Den anbefalede dosis methylnaltrexonbromid er 12 mg (0,6 ml injektionsvæske) subkutant, efter behov, givet som mindst 4 doser om ugen, og op til én gang daglig (7 doser om ugen).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe of 0.6 mL contains 12 mg of methylnaltrexone bromide.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver fyldte injektionssprøjte på 0,6 ml indeholder 12 mg methylnaltrexonbromid.
English: STATEMENT OF ACTIVE SUBSTANCE Each pre-filled syringe of 0.4 mL contains 8 mg of methylnaltrexone bromide.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver fyldte injektionssprøjte på 0,4 ml indeholder 8 mg methylnaltrexonbromid.
English: OTHER Keep the vial in the outer carton in order to protect from light.
Danish: ANDET Opbevar hætteglasset i den ydre karton for at beskytte mod lys.
English: If needed, you may cover the injection site with a plaster.
Danish: Sæt eventuelt et hæfteplaster på injektionsstedet.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of 0.6 mL contains 12 mg of methylnaltrexone bromide.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hvert hætteglas på 0,6 ml indeholder 12 mg methylnaltrexonbromid.
English: What Relistor is and what it is used for What you need to know before you use Relistor How to use Relistor
Danish: Det skal du vide, før du begynder at bruge Relistor Sådan skal du bruge Relistor Bivirkninger
English: Single vial
Danish: Hurtig afføring
English: 0.6 mL (12 mg) More than 114 kg 0.15 mg/kg
Danish: 0,6 ml (12 mg)
English: The recommended dose for patients receiving supportive care in advanced illness is 8 mg methylnaltrexone bromide (0.4 mL of solution) for patients weighing 38-61 kg or 12 mg (0.6 mL of solution) for patients weighing 62-114 kg.
Danish: Den anbefalede dosis methylnaltrexonbromid er 8 mg (0,4 ml injektionsvæske) (til patienter der vejer 38-61 kg) eller 12 mg (0,6 ml injektionsvæske) (til patienter der vejer 62-114 kg).
English: Hydrochloric acid (to adjust pH)
Danish: Natriumcalciumedetat Glycinhydroklorid Vand til injektionsvæsker Saltsyre (til justering af pH) Natriumhydroxid (til justering af pH)
English: Pick up the syringe from your work surface.
Danish: Tag sprøjten op fra underlaget.
English: STATEMENT OF ACTIVE SUBSTANCE Each pre-filled syringe of 0.6 mL contains 12 mg of methylnaltrexone bromide.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas på 0,6 ml indeholder 12 mg methylnaltrexonbromid.
English: Relistor 12 mg/0.6 mL solution for injection Methylnaltrexone bromide
Danish: Relistor 12 mg/0,6 ml injektionsvæske, opløsning.
English: With the needle still in the vial, turn the vial upside-down.
Danish: Lad kanylen blive i hætteglasset og vend hætteglasset, således at det vender på hovedet.
English: Place used pre-filled syringe in a closable, puncture-resistant container.
Danish: Læg den brugte sprøjte i en punkterfri beholder, der kan lukkes.
English: You will be instructed by your doctor, nurse or pharmacist on the techniques of self-injection.
Danish: Læs venligst vejledningen grundigt, og følg den trin for trin. Din læge, sygeplejerske eller apotekspersonalet vil instruere dig i, hvordan du selv kan give injektionen.
English: Talk to your doctor or pharmacist before using Relistor - If you have severe stomach symptoms which continue or get worse, contact your doctor immediately because these could be symptoms of a hole developing in the bowel wall (intestinal perforation).
Danish: Kontakt lægen eller apotekspersonalet, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
English: MARKETING AUTHORISATION NUMBER EU/1/08/463/011
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/08/463/011
English: Each vial contains 0.6 mL of solution for injection.
Danish: Hvert hætteglas indeholder 0,6 ml injektionsvæske, opløsning.
English: MARKETING AUTHORISATION NUMBER EU/1/08/463/010
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/08/463/010
English: MARKETING AUTHORISATION NUMBER EU/1/08/463/007
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/08/463/007
English: MARKETING AUTHORISATION NUMBER EU/1/08/463/009
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/08/463/009
English: 4-week double-blind phase.
Danish: 400 mg-doser cimetidin.
English: What Relistor looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: MARKETING AUTHORISATION NUMBER EU/1/08/463/005
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/08/463/005
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/463/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/08/463/001
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/463/004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/08/463/004
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/463/008
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/08/463/008
English: MARKETING AUTHORISATION NUMBER EU/1/08/463/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/08/463/002
English: MARKETING AUTHORISATION NUMBER EU/1/08/463/006
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/08/463/006
English: MARKETING AUTHORISATION NUMBER EU/1/08/463/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/08/463/003
English: 10 March 2014
Danish: Den 10. marts 2014
English: The European Commission issued a decision on 10 March 2014.
Danish: Europa-Kommissionen traf en beslutning den 10. marts 2014.
English: Outcome of a procedure under Article 29(4) of Directive 2001/83/EC
Danish: Resultatet af en procedure i henhold til artikel 29, stk. 4, i direktiv 2001/83/EF
English: What is Valebo?
Danish: Hvad er Valebo?
English: Why was Valebo reviewed?
Danish: Hvorfor blev Valebo vurderet igen?
English: On 19 December 2013, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Valebo.
Danish: Den 19. december 2013 gennemførte Det Europæiske Lægemiddelagentur en voldgiftsprocedure efter en uoverensstemmelse blandt medlemsstaterne i Den Europæiske Union (EU) om godkendelse af lægemidlet Valebo.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Germany) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Austria, Belgium, Bulgaria, Denmark, France, Hungary, Ireland, the Netherlands, Portugal, Slovakia, Slovenia, Spain and the United Kingdom).
Danish: Ved denne procedure vurderer én medlemsstat (“referencemedlemsstaten”, her Tyskland) et lægemiddel med henblik på udstedelse af en markedsføringstilladelse, der er gyldig i det pågældende land foruden i andre medlemsstater (de “berørte medlemsstater”, her Østrig, Belgien, Bulgarien, Danmark, Frankrig, Ungarn, Irland, Nederlandene, Portugal, Slovakiet, Slovenien, Spanien og Det Forenede Kongerige).
English: However, although alfacalcidol has been shown in some clinical studies to reduce the risk of falls in older people, the Committee considered that this information should be included under section 5.1 of the summary of product characteristics (and not in section 4.1).
Danish: Skønt alfacalcidol i nogle kliniske undersøgelser er påvist at nedsætte risikoen for fald blandt ældre, fandt udvalget dog, at disse oplysninger burde indgå i produktresuméets punkt 5.1 (og ikke i punkt 4.1).
English: However, the Member States were not able to reach an agreement and the German medicines regulatory agency referred the matter to the CHMP for arbitration on 28 February.
Danish: Medlemsstaterne var imidlertid ikke i stand til at nå til enighed, og den tyske lægemiddelstyrelse indbragte den 28. februar sagen for CHMP med henblik på voldgift.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Valebo outweigh its risks, and the marketing authorisation can be granted in Germany and in the following Member States of the EU: Austria, Belgium, Bulgaria, Denmark, France, Hungary, Ireland, the Netherlands, Portugal, Slovakia, Slovenia, Spain and the United Kingdom.
Danish: Agenturets udvalg for lægemidler til mennesker (CHMP) konkluderede, at fordelene ved Valebo er større end risiciene, og at der kan udstedes markedsføringstilladelse i Tyskland og i følgende EU-medlemsstater: Østrig, Belgien, Bulgarien, Danmark, Frankrig, Ungarn, Irland, Nederlandene, Portugal, Slovakiet, Slovenien, Spanien og Det Forenede Kongerige.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that Valebo should be granted marketing authorisation in all concerned Member States for the treatment of postmenopausal women with osteoporosis.
Danish: Efter vurdering af de foreliggende data og den videnskabelige drøftelse i udvalget konkluderede CHMP, at der i alle berørte medlemsstater bør udstedes markedsføringstilladelse for Valebo til behandling af kvinder med knogleskørhed efter overgangsalderen.
English: Alfacalcidol is a type of vitamin D (a ‘vitamin D analogue'), which is required for calcium absorption and normal bone formation.
Danish: Alfacalcidol er en type D-vitamin (en “D-vitaminanalog”), som er nødvendig til optagelse af calcium og normal knogledannelse.
English: Alendronic acid is a bisphosphonate that has been used for osteoporosis since the mid-1990s.
Danish: Alendronsyre er et bifosfonat, som har været anvendt til osteoporose siden midten af 1990'erne.
English: The grounds for the referral was a concern raised by Spain that appropriate data had not been submitted to support a statement which was to be included in the indication for Valebo (in section 4.1 of the summary of product characteristics) that alfacalcidol reduces the rate of falls in older people.
Danish: Begrundelsen for indbringelsen var betænkeligheder rejst af Spanien om, at der ikke var forelagt tilstrækkelige data til dokumentation af udsagnet i indikationen for Valebo (i punkt 4.1 af produktresuméet), om, at alfacalcidol nedsætter hyppigheden af fald hos ældre.
English: Alfacalcidol has been used for many years in women who have been through the menopause.
Danish: Alfacalcidol har været anvendt i mange år hos kvinder efter overgangsalderen.
English: It slows the action of the osteoclasts, the cells that are involved in breaking down the bone tissue.
Danish: Det hæmmer virkningen af osteoklasterne, som er de celler i kroppen, der medvirker ved nedbrydning af knoglevæv.
English: TEVA Pharma B.V. submitted Valebo to the German medicines regulatory agency for a decentralised procedure.
Danish: søgte Valebo godkendt hos den tyske lægemiddelstyrelse ved en decentral procedure.
English: Questions and answers on Valebo and associated names (tablets containing 70 mg alendronic acid and capsules containing 1 microgram alfacalcidol) EMA/793424/2013 rev.1
Danish: Spørgsmål og svar om Valebo og relaterede navne (tabletter indeholdende 70 mg alendronsyre og kapsler indeholdende 1 µg alfacalcidol) EMA/793424/2013 rev.1
English: Valebo is a combination of tablets containing 70 mg alendronic acid and capsules containing 1 microgram alfacalcidol.
Danish: Valebo er en kombinationspakning bestående af tabletter med 70 mg alendronsyre og kapsler med 1 µg alfacalcidol.
English: Questions and answers on Valebo and associated names (tablets containing 70 mg alendronic acid and capsules containing 1 microgram alfacalcidol)
Danish: Spørgsmål og svar om Valebo og relaterede navne (tabletter indeholdende 70 mg alendronsyre og kapsler indeholdende 1 µg alfacalcidol)
English: It is to be used for the treatment of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause.
Danish: Det anvendes til behandling af knogleskørhed (osteoporose) hos kvinder efter overgangsalderen.
English: Suspension (stem cells): 1 ml
Danish: Suspension (stamceller): 1 ml