FrancophonIA/ELRC3.0 huggingface dataset:
English: If a lower dose of Zometa is required, first withdraw the appropriate volume of the reconstituted solution (4 mg/5 ml) as indicated below and then dilute it further with 100 ml of infusion solution.
Danish: Hvis der kræves en nedsat dosis af Zometa, skal der først udtages en passende mindre volumen af den rekonstituerede opløsning (4 mg/5 ml) som angivet nedenfor og derefter fortynde yderligere med 100 ml infusionsopløsning.
English: The following adverse reactions, listed in Table 2, have been accumulated from clinical studies and post-marketing reports following predominantly chronic treatment with 4 mg zoledronic acid:
Danish: De følgende bivirkninger, opført i Tabel 2, er samlet fra kliniske forsøg og post-marketing rapporter efter fortrinsvis kronisk behandling med 4 mg zoledronsyre:
English: The powder must first be reconstituted in the vial using 5 ml water for injections from the ampoule supplied.
Danish: Pulveret skal først rekonstitueres i hætteglasset ved hjælp af 5 ml vand til injektionsvæsker fra den medfølgende ampul.
English: Table 7 Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta
Danish: Tabel 7 Bivirkninger observeret hos pædiatriske patienter med svær osteogenesis imperfecta
English: What Zometa looks like and contents of the pack Zometa is supplied as a solution in a clear, colourless plastic bottle.
Danish: Zometa leveres som en opløsning i en klar, farveløs plastikflaske.
English: Pruritus, rash (including erythematous and macular rash), increased sweating
Danish: Pruritus, udslæt (inklusive erythematøst og makuløst udslæt), øget svedtendens
English: EU/1/01/176/001 1 vial and 1 ampoule EU/1/01/176/002 4 vials and 4 ampoules
Danish: EU/1/01/176/001 1 hætteglas og 1 ampul EU/1/01/176/002 4 hætteglas og 4 ampuller
English: For patients with normal renal function (defined as CLcr > 60 ml/min), zoledronic acid 4 mg/100 ml solution for infusion may be administered directly without any further preparation.
Danish: For patienter med normal nyrefunktion (defineret som CLcr>60 ml/min), kan zoledronsyre 4 mg/100 ml infusionsvæske, opløsning indgives direkte uden nogen yderligere forberedelse.
English: Cardiac arrhythmias and neurologic adverse events (including convulsions, hypoaesthesia and tetany) have been reported secondary to cases of severe hypocalcaemia.
Danish: Hjertearytmi og neurologiske bivirkninger (herunder kramper, hypæstesi og tetani) er blevet rapporteret sekundært til tilfælde af alvorlig hypokalcæmi.
English: The adverse reactions ranked under headings of frequency, are presented in Table 7.
Danish: Bivirkningerne, der er ordnet efter hyppighed, er præsenteret i Tabel 7.
English: High blood pressure, shortness of breath, dizziness, anxiety, sleep disturbances, taste disturbances, trembling, tingling or numbness of the hands or feet, diarrhoea, constipation, abdominal pain, dry mouth.
Danish: - Forhøjet blodtryk, åndenød, svimmelhed, angst, søvnforstyrrelser, smagsforstyrrelser, rysten, følelsesløshed eller prikkende fornemmelse i hænder eller fødder, diarré, forstoppelse, mavesmerter, mundtørhed.
English: In patients with normal renal function, defined as CLcr > 60 ml/min, zoledronic acid 4 mg/100 ml solution for infusion must not be further diluted.
Danish: Hos patienter med normal nyrefunktion, defineret som CLcr>60 ml/min, må zoledronsyre 4 mg/100 ml infusionsvæske, opløsning ikke blive yderligere fortyndet.
English: Zometa recommended dose* 4.0 mg zoledronic acid 3.5 mg* zoledronic acid 3.3 mg* zoledronic acid 3.0 mg* zoledronic acid * Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr = 75 ml/min).
Danish: Anbefalet dosis af Zometa* 4,0 mg zoledronsyre 3,5 mg* zoledronsyre 3,3 mg* zoledronsyre 3,0 mg* zoledronsyre *Dosis er beregnet ud fra forudsætning om et mål-AUC på 0,66 (mg•t/l) (CLcr=75 ml/min).
English: In clinical trials with Zometa, patients with serum creatinine > 265 µmol/l or > 3.0 mg/dl were excluded.
Danish: I kliniske forsøg med Zometa blev patienter med serum-kreatinin >265 mol/l eller >3,0 mg/dl ekskluderet.
English: One vial with 5 ml concentrate for solution for infusion Component of a multipack comprising ten packs, each containing one vial
Danish: 1 hætteglas med 5 ml koncentrat til infusionsvæske, opløsning Del af multipakning bestående af 10 pakninger som hver indeholder 1 hætteglas
English: Unit packs containing 1 or 4 vials and 1 or 4 ampoules of water for injections, respectively.
Danish: Enkeltpakninger indeholdende henholdsvis 1 eller 4 hætteglas og 1 eller 4 ampuller med vand til injektionsvæsker.
English: Solvent ampoule: 5-ml colourless glass ampoule.
Danish: Opløsningsmiddel ampul: 5 ml farveløs ampul af glas
English: You must not be given Zometa if you are breast-feeding.
Danish: Du må ikke få Zometa, hvis du ammer.
English: Dizziness, paraesthesia, dysgeusia, hypoaesthesia, hyperaesthesia, tremor, somnolence
Danish: Svimmelhed, paræstesier, dysgeusi, hypæstesi, hyperæstesi, tremor, døsighed
English: Acute renal failure, haematuria, proteinuria
Danish: Akut nyresvigt, hæmaturi, proteinuri
English: You should not be given Zometa if you are pregnant.
Danish: Graviditet og amning Du bør ikke få Zometa, hvis du er gravid.
English: WRAPPER LABEL ON MULTIPACKS WRAPPED IN FOIL (INCLUDING BLUE BOX)
Danish: ETIKET PÅ MULTIPAKNINGEN PAKKET I FOLIE (INKLUSIVE ”BLUE BOX”)
English: Since no data are available on the compatibility of Zometa with other intravenously administered substances, Zometa must not be mixed with other medications/substances and should always be given through a separate infusion line.
Danish: Da der ikke eksisterer data om forligeligheden af Zometa med andre intravenøst indgivne stoffer, må Zometa ikke blandes med andre lægemidler eller stoffer og bør altid indgives gennem en separat infusionsslange.
English: To prepare an infusion solution containing 4 mg zoledronic acid, add 5 ml of water for injections from the ampoule supplied in the pack to the vial containing the Zometa powder under aseptic conditions.
Danish: Når du skal tilberede en infusionsvæske indeholdende 4 mg zoledronsyre, skal du under aseptiske forhold tilsætte 5 ml vand til injektion fra den ampul, der følger med pakningen til hætteglasset med Zometa pulveret.
English: No dose adjustment is necessary in TIH patients with serum creatinine < 400 µmol/l or < 4.5 mg/dl (see section 4.4).
Danish: Det er ikke nødvendigt at dosisjustere patienter med TIH og serum-kreatinin <400 μmol/l eller <4,5 mg/dl (se afsnit 4.4).
English: Zometa 4 mg/100 ml solution for infusion should be given as a single intravenous infusion in no less than 15 minutes.
Danish: Zometa 4 mg/100 ml infusionsvæske, opløsning skal indgives som en enkelt intravenøs infusion over minimum 15 minutter.
English: Day 10
Danish: 10. dag
English: To prepare an infusion solution containing 4 mg zoledronic acid, further dilute the Zometa concentrate (5.0 ml) with 100 ml of calcium-free or other divalent cation-free infusion solution.
Danish: Når du skal tilberede en infusionsvæske indeholdende 4 mg zoledronsyre, skal du opløse Zometa koncentratet (5,0 ml) yderligere med 100 ml calciumfri eller anden infusionsvæske uden indhold af divalente kationer.
English: Zometa 4 mg/100 ml solution for infusion contains 4 mg zoledronic acid in 100 ml of infusion solution for immediate use in patients with normal renal function.
Danish: Zometa 4 mg/100 ml infusionsvæske, opløsning indeholder 4 mg zoledronsyre i 100 ml infusionsvæske, opløsning, som er klar til brug hos patienter med normal nyrefunktion.
English: Multi-packs containing 10 (10 packs of 1) vials.
Danish: Multipakninger indeholdende 10 (10 pakninger af 1) hætteglas.
English: The adverse reactions ranked under headings of frequency, are presented in Table 6.
Danish: Bivirkningerne, der er ordnet efter hyppighed, er præsenteret i Tabel 6.
English: Respiratory, thoracic and mediastinal disorders Uncommon:
Danish: Luftveje, thorax og mediastinum Ikke almindelig
English: Osteonecrosis of the external auditory canal has been reported with bisphosphonates, mainly in association with long-term therapy.
Danish: Der er rapporteret osteonekrose af øregangen med bisfosfonater, hovedsageligt i forbindelse med langtidsbehandling.
English: In patients with bone metastases presenting with mild to moderate renal impairment prior to initiation of therapy, which is defined for this population as CLcr 30-60 ml/min, the following Zometa dose is recommended (see also section 4.4):
Danish: Til patienter med knoglemetastaser, der før behandlingen initieres, har mild til moderat nyreinsufficiens, som i denne population er defineret som CLcr 30-60 ml/min, anbefales følgende dosis af Zometa (se også afsnit 4.4):
English: Osteonecrosis of the jaw (ONJ) has been reported uncommonly in clinical trials and in the post-marketing setting in patients receiving Zometa.
Danish: Osteonekrose af kæberne er blevet rapporteret med frekvensen ”ikke almindelig” i kliniske forsøg og efter markedsføring hos patienter behandlet med Zometa.
English: Gastrointestinal reactions such as nausea and vomiting as well as loss of appetite.
Danish: - Mave-tarm-symptomer såsom kvalme og opkastning samt appetitløshed.
English: Increased sweating.
Danish: - Øget svedtendens.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C.
Danish: Hvis den ikke anvendes straks, er opbevaringstid og -betingelser før brug brugerens ansvar og bør normalt ikke overstige 24 timer ved 2 °C - 8 °C.
English: Caution is advised when Zometa is administered with anti-angiogenic medicinal products, as an increase in the incidence of ONJ has been observed in patients treated concomitantly with these medicinal products.
Danish: Der tilrådes forsigtighed, når Zometa indgives sammen med anti-angiogene lægemidler, da der er set en øget hyppighed af osteonekrose af kæberne hos patienter i samtidig behandling med disse lægemidler.
English: Placebo zoledronic acid 4 mg
Danish: Placebo Zoledronsyre 4 mg
English: • Breast-feeding (see section 4.6).
Danish: • Amning (se pkt.
English: Further dilute the Zometa reconstituted solution (5 ml) with 100 ml of calcium-free or other divalent cation-free infusion solution.
Danish: Fortynd den opløste Zometa opløsning (5 ml) yderligere med 100 ml infusionsvæske som er calciumfri eller fri for andre divalente kationer.
English: From a microbiological point of view, the solution for infusion should be used immediately, after first opening.
Danish: Ud fra et mikrobiologisk synspunkt skal opløsningen til infusion anvendes straks efter åbning.
English: In patients with bone metastases presenting with mild to moderate renal impairment prior to initiation of therapy, which is defined for this population as CLcr 30-60 ml/min, reduced Zometa doses are recommended (see also section 4.4).
Danish: Til patienter med knoglemetastaser, der før behandlingen initieres, har mild til moderat nyreinsufficiens, som i denne population er defineret som CLcr 30-60 ml/min, anbefales nedsatte doser af Zometa (se også afsnit 4.4).
English: How Zometa is used
Danish: Hvordan skal Zometa opbevares
English: In some instances, the hypocalcaemia may be life-threatening (see section 4.8).
Danish: I nogle tilfælde er livstruende hypokalcæmi forekommet (se pkt.
English: - History of dental disease, poor oral hygiene, periodontal disease, invasive dental procedures
Danish: - Tandsygdom i anamnesen, dårlig mundhygiejne, parodontal sygdom, invasiv tandbehandling
English: How to prepare and administer Zometa
Danish: Tilberedelse og indgift af Zometa
English: Multiple event analysis showed 30.7% risk reduction in developing SREs in the zoledronic acid 4 mg group compared with placebo.
Danish: Analyser af gentagne hændelser viste risikoreduktion på 30,7% i udviklingen af skeletrelaterede hændelser i zoledronsyre 4 mggruppen sammenlignet med placebo.
English: Weight increase.
Danish: - Vægtøgning.
English: In patients with mild to moderate renal impairment, reduced Zometa doses are recommended (see section “Posology” above and section 4.4).
Danish: Hos patienter med let til moderat nedsat nyrefunktion, anbefales nedsatte doser af Zometa (se afsnittet ”Dosering” ovenfor samt pkt.
English: Fever, flu-like syndrome (including fatigue, rigors, malaise and flushing)
Danish: Feber, influenzalignende syndrom (inkluderende træthed, kulderystelser, utilpashed og hedeture)
English: Zometa is supplied as unit packs containing 1 or 4 vials and 1 or 4 ampoules, respectively, and as multi-packs containing 10 (10x 1+1) vials and ampoules.
Danish: Zometa leveres i enkeltpakninger, som indeholder henholdvis 1 eller 4 hætteglas og 1 eller 4 ampuller, og i multipakninger, som indeholder 10 (10x 1+1) hætteglas og ampuller.
English: FOLDING BOX - OUTER CONTAINER OF MULTIPACK (WITH BLUE BOX)
Danish: KARTON - YDERPAKNING TIL MULTIPAKNING (MED BLUE BOX)
English: What Zometa is and what it is used for What you need to know before you are given Zometa How Zometa is used
Danish: Virkning og anvendelse Det skal du vide, før du får Zometa Sådan bliver du behandlet med Zometa Bivirkninger
English: Clinical trial results in the treatment of severe osteogenesis imperfecta in paediatric patients aged 1 to 17 years
Danish: Resultater fra kliniske undersøgelser hos pædiatriske patienter i alderen 1 til 17 år behandlet for svær osteogenesis imperfecta
English: Diarrhoea, constipation, abdominal pain, dyspepsia, stomatitis, dry mouth
Danish: Diarré, obstipation, abdominalsmerter, dyspepsi, stomatitis, mundtørhed
English: FOLDING BOX - INTERMEDIATE CONTAINER OF MULTIPACK (WITHOUT BLUE BOX)
Danish: KARTON - DELPAKNING AF MULTIPAKNING (UDEN BLUE BOX)
English: Prevention of skeletal related events in patients with advanced malignancies involving bone: When initiating treatment with Zometa in patients with multiple myeloma or metastatic bone lesions from solid tumours, serum creatinine and creatinine clearance (CLcr) should be determined.
Danish: Når behandling med Zometa initieres hos patienter med multipelt myelom eller knoglemetastatisk skade fra solide tumorer bør serum-kreatinin og kreatininclearence (CLcr) bestemmes.
English: The active substance of Zometa is zoledronic acid.
Danish: Aktivt stof: zoledronsyre.
English: Irregular heart beat (cardiac arrhythmia), seizures, spasm and twitching (tetany) have been reported as secondary to severe hypocalcaemia.
Danish: Uregelmæssig hjerterytme (hjertearytmi), anfald, spasmer og krampetilfælde (tetani) er indberettet som sekundære symptomer ved alvorlig hypokalcæmi.
English: Unit packs containing 1 bottle.
Danish: Enkeltpakninger indeholdende 1 flaske.
English: Prior to administration, 5.0 ml concentrate from one vial or the volume of the concentrate withdrawn as required must be further diluted with 100 ml of calcium-free infusion solution (0.9% w/v sodium chloride solution or 5% w/v glucose solution).
Danish: Før administration skal 5,0 ml koncentrat fra et hætteglas eller det påkrævede udtagende volumen af koncentratet fortyndes yderligere med 100 ml calciumfri infusionsvæske (0,9% w/v natriumklorideller 5% w/v glucoseinjektions-/infusionsvæske).
English: It also contains mannitol, sodium citrate and water for injections.
Danish: Indeholder også mannitol, natriumcitrat og vand til injektionsvæsker.
English: It is given as a single 15-minute intravenous infusion in a separate infusion line.
Danish: Det indgives ved en enkelt intravenøs infusion over 15 minutter i en separat infusionsslange.
English: Table 5 Efficacy results (breast cancer and multiple myeloma patients)
Danish: Tabel 5 Effektresultater (patienter med brystcancer eller multipelt myelom)
English: Renal deterioration, progression to renal failure and dialysis have been reported in patients after the initial dose or a single dose of 4 mg zoledronic acid (see section 4.4).
Danish: Der er rapporteret om forværring af nyrefunktionen, progression til nyresvigt og dialyse hos patienter efter den initiale dosis og efter 4 mg enkeltdosis af zoledronsyre (se pkt.
English: Muscle spasms, osteonecrosis of the jaw
Danish: Muskelspasmer, osteonekrose af kæberne
English: Table 3 Efficacy results (solid tumours other than breast or prostate cancer)
Danish: Tabel 3 Effektresultater (solide tumorer udover bryst- og prostatacancer)
English: Sodium citrate Water for injections
Danish: Natriumcitrat Vand til injektionsvæsker
English: Skin reactions (redness and swelling) at the infusion site, rash, itching.
Danish: - Hudreaktioner (rødme og hævelse) på infusionsstedet, udslæt, kløe.
English: The unopened vial does not require any specific storage conditions.
Danish: Det uåbnede hætteglas kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: Convulsions, hypoaesthesia and tetany (secondary to hypocalcaemia)
Danish: Kramper, hypæstesi og tetani (sekundært til hypokalcæmi)
English: Acute phase reaction
Danish: Akut fasereaktion
English: Difficulty in breathing with wheezing or coughing.
Danish: Vejrtrækningsbesvær med hiven efter vejret eller hosten.
English: Zometa 4 mg/100 ml solution for infusion must not be mixed with other infusion solutions and should be administered as a single intravenous solution in a separate infusion line.
Danish: Zometa 4 mg/100 ml infusionsvæske, opløsning må ikke blandes med andre infusionsvæsker og bør indgives som en enkelt intravenøs opløsning i en separat infusionsslange.
English: Table 4 Efficacy results (breast cancer and multiple myeloma patients)
Danish: Tabel 4 Effektresultater (patienter med brystcancer eller multipelt myelom)
English: Unit packs containing 1 or 4 vials.
Danish: Enkeltpakninger indeholdende 1 eller 4 hætteglas.
English: Severe kidney impairment (will normally be determined by your doctor with certain specific blood tests).
Danish: Almindelig (forekommer hos op til 1 ud af 10 patienter): - Svært nedsat nyrefunktion (vil normalt blive afgjort af din læge ved hjælp af en speciel type blodprøver).
English: Zoledronic acid 4 mg (N=86) 45.3% (p=0.104)
Danish: Zoledronsyre 4 mg (N = 86)
English: Tell your doctor about any of the following serious side effects straight away:
Danish: Giv straks lægen besked, hvis du bemærker en eller flere af nedenstående bivirkninger:
English: Table 4 Efficacy results (solid tumours other than breast or prostate cancer)
Danish: Tabel 4 Effektresultater (solide tumorer udover bryst- og prostatacancer)
English: Hypocalcaemia
Danish: Hypofosfatæmi
English: This adverse drug reaction consists of a constellation of symptoms that includes fever, myalgia, headache, extremity pain, nausea, vomiting, diarrhoea, arthralgia and arthritis with subsequent joint swelling.
Danish: Denne bivirkning består af en række symptomer der inkluderer feber, myalgi, hovedpine, smerter i arme og ben, kvalme, opkastning, diarré, artralgi og artritis med efterfølgende hævede led.
English: Multiple event analysis showed a 36% risk reduction in developing SREs in the zoledronic acid 4 mg group compared with placebo.
Danish: Analyser af gentagne hændelser viste risikoreduktion på 36% i udviklingen af skeletrelaterede hændelser i zoledronsyre 4 mg-gruppen sammenlignet med placebo.
English: After reconstitution and dilution: From a microbiological point of view, the reconstituted and diluted solution for infusion should be used immediately.
Danish: Efter rekonstituering og fortynding: Ud fra et mikrobiologisk synspunkt skal den rekonstituerede og fortyndede opløsning til infusion anvendes straks.
English: One vial contains 4 mg of zoledronic acid.
Danish: Et hætteglas indeholder 4 mg zoledronsyre.
English: Fracture adverse events of long bones in the lower extremities were reported in approximately 24% (femur) and 14% (tibia) of zoledronic acid-treated patients vs 12% and 5% of pamidronate-treated patients with severe osteogenesis imperfecta, regardless of disease type and causality but overall incidence of fractures was comparable for the zoledronic acid and pamidronate-treated patients: 43% (32/74) vs 41% (31/76).
Danish: Bivirkninger i form af frakturer på lange knogler i de nedre ekstremiteter var rapporteret hos ca. 24% (femur) og 14% (tibia) af zoledronsyrebehandlede patienter vs. 12% og 5% af pamidronatbehandlede patienter med svær osteogenesis imperfecta uanset sygdomstype og kausalitet.
English: One vial with 5 ml concentrate for solution for infusion Four vials with 5 ml concentrate for solution for infusion
Danish: 1 hætteglas med 5 ml koncentrat til infusionsvæske, opløsning 4 hætteglas med 5 ml koncentrat til infusionsvæske, opløsning
English: The solution containing zoledronic acid is given as a single 15-minute intravenous infusion in a separate infusion line.
Danish: Opløsningen indeholdende zoledronsyre indgives ved en enkelt intravenøs infusion over 15 minutter i en separat infusionsslange.
English: FOLDING BOX FOR 1 VIAL AS UNIT PACK (INCLUDING BLUE BOX) FOLDING BOX FOR 4 VIALS AS UNIT PACK (INCLUDING BLUE BOX)
Danish: ÆSKE TIL 1 HÆTTEGLAS SOM ENKELT PAKNING (INKLUSIVE ”BLUE BOX”) ÆSKE TIL 4 HÆTTEGLAS SOM ENKELT PAKNING (INKLUSIVE ”BLUE BOX”)
English: Multipack comprising ten packs, each containing one vial and one ampoule of solvent 5 ml.
Danish: Komponenterne af multipakningen består af ti pakninger, som hver består af et hætteglas og en ampul med opløsningsmiddel 5 ml.
English: Talk to your doctor before you are given Zometa: if you have or have had a kidney problem.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før du begynder at få Zometa: hvis du har eller har haft en nyrelidelse.
English: Zometa is supplied as unit packs containing 1 or 4 vials and as multi-packs containing 10 (10x1) vials.
Danish: Zometa leveres i enkeltpakninger, som indeholder 1 eller 4 hætteglas og i multipakninger, som indeholder 10 (10x1) hætteglas.
English: Zometa is contraindicated in breast-feeding women (see section 4.3).
Danish: Zometa er kontraindikeret hos kvinder, der ammer (se pkt.
English: The hydration status of patients must be assessed prior to and following administration of Zometa to ensure that they are adequately hydrated.
Danish: Patienternes hydreringsstatus skal vurderes før og efter indgivelsen af Zometa for at sikre, at de er tilstrækkeligt hydrerede.
English: Additional risk minimisation measures The MAH shall ensure that a patient reminder card regarding osteonecrosis of the jaw is implemented.
Danish: Indehaveren af markedsføringstilladelsen skal sikre at der implementeres patienthuskekort vedrørende osteonekrose af kæberne.
English: Clinical trial results in the prevention of skeletal related events in patients with advanced malignancies involving bone
Danish: Resultater fra kliniske studier vedrørende forebyggelse af skeletrelaterede hændelser hos patienter med fremskreden malign sygdom og knoglemetastaser
English: In the clinical studies, patients with serum creatinine > 400 µmol/l or > 4.5 mg/dl were excluded.
Danish: I kliniske forsøg blev patienter med serum-kreatinin >400 μmol/l eller >4,5 mg/dl ekskluderet.
English: Flu-like symptoms including arthritis and joint swelling.
Danish: - Influenza-lignende symptomer herunder gigt (artritis) og hævede led.
English: Powder and solvent for solution for infusion
Danish: Pulver og solvens til infusionsvæske, opløsning
English: After first opening: From a microbiological point of view, the solution for infusion should be used immediately.
Danish: Efter åbning: Ud fra et mikrobiologisk synspunkt skal opløsningen til infusion anvendes straks.
English: From a microbiological point of view, the reconstituted and diluted solution for infusion should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt skal den rekonstituerede og fortyndede opløsning til infusion anvendes straks.
English: Efficacy results are provided in Table 5.
Danish: Effektresultaterne kan ses i Tabel 5.
English: Pain in the mouth, teeth and/or jaw, swelling or non-healing sores inside the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth.
Danish: Ikke almindelig (forekommer hos op til 1 ud af 100 patienter): - Smerter i munden, tænder og/eller kæberne, hævelse eller ikke helende sår inde i munden eller kæben, udflåd af gullig betændelse, følelsesløshed eller følelsen af tyngde i kæberne eller løsnen af en tand.