natgillin/translations-raw huggingface dataset:
Hoste, dyspnø
Uncommon Cough, dyspnoea
Det skal indgives ved en enkelt intravenøs infusion over 15 minutter i en separat infusionsslange.
It is given as a single 15-minute intravenous infusion in a separate infusion line.
Osteonekrose af øregangen (klasse-bivirkning for bisfosfonater) og andre anatomiske steder, inklusive femur og hofte
Very rare Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) and other anatomical sites including femur and hip
Kontakt straks din læge eller tandlæge, hvis du får nogle problemer med din mund eller tænder, som fx tab af tænder, smerte eller hævelse, eller manglende sårheling eller pus fra såret, da dette kan være tegn på osteonekrose i kæben.
Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, or non-healing of sores or discharge, as these could be signs of osteonecrosis of the jaw.
• Overfølsomhed over for det aktive stof, andre bisfosfonater eller over for et eller flere af hjælpestofferne angivet i pkt.
•Hypersensitivity to the active substance, to other bisphosphonates or to any of the excipients listed in section 6.1.
Patienter i behandling med zoledronsyre bør få udleveret indlægssedlen og patienthuskekortet.
Patients treated with zoledronic acid should be given the package leaflet and the patient reminder card.
Udslæt, hyperhidrose, pruritus, erytem
Uveitis, episcleritis, iritis
Sjældne tilfælde af dialysekrævende nyresvigt og sjældne tilfælde med letal udgang er rapporteret hos patienter med forudeksisterende nedsat nyrefunktion eller andre risikofaktorer som fremskreden alder, samtidig anvendelse af nefrotoksiske lægemidler, samtidig anvendelse af diuretika eller dehydrering efter behandlingen med zoledronsyre (se pkt.
Rare cases of renal failure requiring dialysis and rare cases with a fatal outcome have been reported in patients with pre-existing renal dysfunction or other risk factors such as advanced age, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, or dehydration in the post infusion period (see sections 4.4 and 4.8 Class effects)
- Brug ikke lægemidlet efter den udløbsdato, der står på kartonen og flasken efter udløbsdatoen.
- Do not use this medicine after the expiry date which is stated on the carton.
Almindelig Influenzalignende sygdom, kulderystelser, træthed, asteni, smerter, utilpashed, reaktioner på infusionsstedet
Common Influenza-like illness, chills, fatigue, asthenia, pain, malaise, infusion site reaction
I kliniske forsøg med zoledronsyre blev patienter med serum-kreatinin >265 μmol/l eller >3,0 mg/dl ekskluderet.
In clinical trials with zoledronic acid, patients with serum creatinine > 265 µmol/l or > 3.0 mg/dl were excluded.
- Øgning på 1,0 mg/dl eller 88 μmol/l hos patienter med abnorm kreatinin ved baseline (>1,4 mg/dl eller >124 μmol/l).
- For patients with abnormal baseline creatinine (> 1.4 mg/dl or > 124 µmol/l), an increase of 1.0 mg/dl or 88 µmol/l.
Zoledronsyre Hospira opløsning må ikke blandes med calciumholdige eller andre divalente kationholdige opløsninger som Ringer's laktatopløsning.
Do not mix Zoledronic Acid Hospira concentrate with calcium-containing or other divalent cation containing solutions such as lactated Ringer's solution.
Frekvensen af atrieflimren som alvorlig utilsigtet hændelse var 1,3% (51 ud af 3.862) og 0,6% (22 ud af 3.852) hos patienter som fik henholdsvis zoledronsyre 5 mg og placebo.
The rate of atrial fibrillation serious adverse events was 1.3% (51 out of 3,862) and 0.6% (22 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively.
Det er ikke nødvendigt at dosisjustere patienter med TIH og serum-kreatinin <400 μmol/l eller <4,5 mg/dl (se pkt.
No dose adjustment is necessary in TIH patients with serum creatinine < 400 µmol/l or < 4.5 mg/dl (see section 4.4).
Tilfælde af osteonekrose i kæberne er blevet rapporteret, overvejende hos cancerpatienter i behandling med lægemidler, der hæmmer knogleresorption, såsom zoledronsyre (se pkt.
Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patients treated with medicinal products that inhibit bone resorption, such as zoledronic acid (see section 4.4).
Nældefeber.
− Urticaria.
Infusionsvæske, opløsning 4 mg/100 ml
Solution for infusion 4 mg/100 ml
Analyser af gentagne hændelser viste risikoreduktion på 30,7% i udviklingen af skeletrelaterede hændelser i zoledronsyre 4 mg-gruppen sammenlignet med placebo.
Multiple event analysis showed 30.7% risk reduction in developing SREs in the zoledronic acid 4 mg group compared with placebo.
Takykardi Luftveje, thorax og mediastinum Almindelig:
Tachycardia Respiratory, thoracic and mediastinal disorders Common:
Det skal du vide, før du får Zoledronsyre Hospira
What you need to know before you are given Zoledronic Acid Hospira
Effektresultaterne kan ses i tabel 5.
Efficacy results are provided in Table 5.
Osteonekrose Osteonekrose af kæberne
Osteonecrosis Osteonecrosis of the jaw
Bivirkningerne er ordnet under overskrifter om hyppighed, den hyppigste først, ved brug af de følgende konventionelle regler: Meget almindelig (1/10), almindelig (1/100 til <1/10), ikke almindelig (1/1.000 til <1/100), sjælden (1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: Very common ( 1/10), common ( 1/100 to <1/10), uncommon ( 1/1,000 to <1/100), rare ( 1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Osteonekrose af kæberne er blevet rapporteret med frekvensen ”ikke almindelig” i kliniske forsøg og efter markedsføring hos patienter behandlet med zoledronsyre.
Osteonecrosis of the jaw has been reported uncommonly in clinical trials and in the post-marketing setting in patients receiving zoledronic acid.
Zoledronsyre Hospira leveres i pakninger indeholdende 1 pose.
Zoledronic Acid Hospira is supplied as packs containing 1 bag.
Dette lægemiddel må ikke blandes med infusionsopløsninger indeholdende calcium eller andre divalente kationer så som Ringer's laktatopløsning og bør administreres som en enkelt intravenøs infusion i en separat infusionsslange.
This medicinal product must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer's solution, and should be administered as a single intravenous solution in a separate infusion line.
Zoledronsyre er kontraindiceret til patienter med kreatinin clearance < 35 ml/min (se pkt.
Zoledronic acid is contraindicated in patients with creatinine clearance < 35 ml/min (see sections 4.3 and 4.4).
Den renale clearance af zoledronsyre korrelerer tydeligt med kreatinin clearance, idet den renale clearance udgjorde 75 ± 33 % af kreatinin clearance, hvilket viste en median på 84 ± 29 ml/min (varierende fra 22 til 143 ml/min) hos de 64 undersøgte patienter.
The renal clearance of zoledronic acid was correlated with creatinine clearance, renal clearance representing 75 ± 33% of the creatinine clearance, which showed a mean of 84 ± 29 ml/min (range 22 to 143 ml/min) in the 64 patients studied.
- Forhøjet blodtryk, åndenød, svimmelhed, angst, søvnforstyrrelser, smagsforstyrrelser, rysten, følelsesløshed eller prikkende fornemmelse i hænder eller fødder, diarré, forstoppelse, mavesmerter, mundtørhed.
− High blood pressure, shortness of breath, dizziness, anxiety, sleep disturbances, taste disturbances, trembling, tingling or numbness of the hands or feet, diarrhea, constipation, abdominal pain, dry mouth.
Den udtagne mængde af koncentratet skal fortyndes yderligere i 100 ml sterilt natriumchlorid 9 mg/ml (0,9%) opløsning til injektion eller 5% w/v glukoseopløsning.
The withdrawn amount of concentrate must be further diluted in 100 ml of sterile sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution.
Overfølsomhedsreaktioner
− Hypersensitivity reactions.
Tilfælde af osteonekrose afkæberne er blevet rapporteret overvejende hos cancerpatienter, der er i behandling med lægemidler, der hæmmer knogleresorption, herunder zoledronsyre(se pkt.
Cases of osteonecrosis of the jaw have been reported; predominantly in cancer patients treated with medicinal products that inhibit bone resorption, including zoledronic acid (see section 4.4).
Fjern følgende mængde af Zoledronsyre Hospira 4 mg/100 ml infusionsvæske, opløsning (ml)
Remove the following amount of Zoledronic Acid Hospira 4 mg/100 ml solution for infusion (ml)
Almindelige (kan forekomme hos op til 1 ud af 10 patienter) Hovedpine, svimmelhed, kvalme, opkastninger, diarré, muskelsmerter, knogle- og/eller ledsmerter, smerter i ryg, arme eller ben, influenzalignende symptomer (f.eks. træthed, kuldegysninger, led- og muskelsmerter), kuldegysninger, følelse af træthed og manglende interesse, svækkelse, smerter, sygdomsfølelse, hævelse og/eller smerte ved infusionsstedet.
Headache, dizziness, sickness, vomiting, diarrhoea, pain in the muscles, pain in the bones and/or joints, pain in the back, arms or legs, flu-like symptoms (e.g. tiredness, chills, joint and muscle pain), chills, feeling of tiredness and lack of interest, weakness, pain, feeling unwell, swelling and/or pain at the infusion site.
Tilfælde af osteonekrose af kæberne er blevet rapporteret efter markedsføring for zoledronsyre.
Cases of ONJ have been reported in the postmarketing setting for zoledronic acid.
- Den uåbnede pose kræver ingen særlige forholdsregler vedrørende opbevaringen.
- The unopened bag does not require any special storage conditions.
Placebo Zoledronsyre 4 mg
Placebo zoledronic acid
- Øgning på 0,5 mg/dl eller 44 μmol/l hos patienter med normal serum-kreatinin ved baseline (<1,4 mg/dl eller <124 μmol/l);
- For patients with normal baseline serum creatinine (< 1.4 mg/dl or < 124 µmol/l), an increase of 0.5 mg/dl or 44 µmol/l;
Manglende akkumulering af stof givet som flere doser uanset nyrefunktionen, indikerer, at dosisjustering af zoledronsyre ved mild (Clkr = 50-80 ml/min) og moderat nedsat nyrefunktion ned til en kreatinin clearance på 35 ml/min ikke er nødvendig.
Small observed increases in AUC(0-24hr), by about 30% to 40% in mild to moderate renal impairment, compared to a patient with normal renal function, and lack of accumulation of medicinal product with multiple doses irrespective of renal function, suggest that dose adjustments of zoledronic acid in mild (Clcr = 50-80 ml/min) and moderate renal impairment down to a creatinine clearance of 35 ml/min are not necessary.
Tabel 4: Effektresultater (patienter med brystcancer eller multipelt myelom) Enhver SRE (+TIH)
Table 4: Efficacy results (breast cancer and multiple myeloma patients) Any SRE (+TIH)
Zoledronsyre Hospira leveres i pakninger indeholdende én pose.
Zoledronic Acid Hospira is supplied as packs containing one bag.
KARTON TIL 1 HÆTTEGLAS SOM ENKELTPAKNING
CARTON FOR 1 VIAL AS UNIT PACK
Zoledronsyre udviser ingen mærkbar binding til plasmaproteiner og hæmmer ikke de humane P450-enzymer in vitro (se pkt.
Zoledronic acid shows no appreciable binding to plasma proteins and does not inhibit human P450 enzymes in vitro (see section 5.2), but no formal clinical interaction studies have been performed.
3,5 mg* zoledronsyre
3.5 mg* zoledronic acid
Almindelig: Øget serum kreatinin og serumurea, hypokalcæmi Ikke almindelig:
Blood creatinine and blood urea increased, hypocalcaemia Uncommon: Hypomagnesaemia, hypokalaemia Rare:
Den renale clearance af zoledronsyre korrelerer tydeligt med kreatinin clearance, idet den renale clearance er ansvarlig for 75 ± 33% af kreatinin clearance, hvilket viser en median på 84 ± 29 ml/min (varierende fra 22 til 143 ml/min) hos de 64 undersøgte cancerpatienter.
The renal clearance of zoledronic acid was correlated with creatinine clearance, renal clearance representing 75 ± 33% of the creatinine clearance, which showed a mean of 84 ± 29 ml/min (range 22 to 143 ml/min) in the 64 cancer patients studied.
- Dette produkt kræver ingen særlige forholdsregler vedrørende opbevaringen.
- This product does not require any special storage conditions.
Tilberedelse og indgift af Zoledronsyre Hospira - Zoledronsyre Hospira 4 mg/100 ml infusionsvæske, opløsning indeholder 4 mg zoledronsyre i 100 ml infusionsvæske, opløsning, som er klar til brug til patienter med normal nyrefunktion.
- Zoledronic Acid Hospira 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.
Tilberedelse og administration af Zoledronsyre Hospira:
How to prepare and administer Zoledronic Acid Hospira
Pakningsstørrelser og yderligere oplysninger Zoledronsyre Hospira 5 mg/100 ml infusionsopløsning indeholder: - Aktivt stof: zoledronsyre.
What Zoledronic Acid Hospira 5 mg/100 ml solution for infusion contains - The active substance is zoledronic acid.
Effektresultaterne kan ses i tabel 2.
Efficacy results are provided in Table 2.
Giv straks din læge besked, hvis du bemærker en eller flere af nedenstående bivirkninger:
Tell your doctor about any of the following serious side effects straight away:
Osteonekrose af øregangen (klassebivirkning for bisfosfonater) og andre anatomiske steder inklusiv femur og hoften
Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) and other anatomical sites including femur and hip Renal and urinary disorders Common:
Mens du er i behandling med Zoledronsyre Hospira, skal du holde en god mundhygiejne (inkl.
While being treated with Zoledronic Acid Hospira, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Abdominalsmerter Knogler, led, muskler og bindevæv Almindelig:
Abdominal pain Musculoskeletal and connective tissue disorders Common:
For at forhindre eventuelle uforligeligheder skal Zoledronsyre Hospira fortyndes med natriumklorid 9 mg/ml (0,9% ) opløsning til injektion eller 5% w/v glukoseopløsning.
To avoid potential incompatibilities, Zoledronic Acid Hospira is to be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution.
- Kun til engangsbrug.
- For single use only.
Nedsat nyrefunktion, osteonekrose af kæberne, akut fasereaktion, hypokalcæmi, atrieflimren, anafylaksi, interstitiel lungesygdom.
Renal function impairment, osteonecrosis of the jaw, acute phase reaction, hypocalcaemia, atrial fibrillation, anaphylaxis, Interstitial lung disease.
Du må ikke få Zoledronsyre Hospira, hvis du ammer.
You must not be given Zoledronic Acid Hospira if you are breast-feeding.
Tabel 3: Effektresultater (solide tumorer udover bryst- og prostatacancer) Enhver SRE (+TIH)
Table 3: Efficacy results (solid tumours other than breast or prostate cancer) Any SRE (+TIH)
Asteni, perifere ødemer, reaktioner ved injektionsstedet (inklusive smerter, irritation, hævelse, induration), brystsmerter, vægtøgning, anafylaktisk reaktion/shock, urticaria
Fever, flu-like syndrome (including fatigue, rigors, malaise and flushing) Uncommon: Asthenia, peripheral oedema, injection site reactions (including pain, irritation, swelling, induration), chest pain, weight increase, anaphylactic reaction/shock, urticaria
Zoledronsyre Hospira må ikke blandes med calcium eller anden divalent kationholdig infusionsopløsning såsom Ringer's laktatopløsning, og bør indgives som en enkelt intravenøs opløsning i en separat infusionsslange.
Zoledronic Acid Hospira must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer's solution, and should be administered as a single intravenous solution in a separate infusion line.
- Dårlig mundhygiejne, parodontal sygdom, dårligt tilpassede tandproteser, tandsygdom i anamnesen, invasiv tandbehandling fx udtrækning af en tand.
- Poor oral hygiene, periodontal disease, poorly fitting dentures, history of dental disease, invasive dental procedures, e.g. tooth extractions.
Tabel 4: Effektresultater (solide tumorer udover bryst- og prostatacancer) Enhver SRE (+TIH)
Table 4: Efficacy results (solid tumours other than breast or prostate cancer) Any SRE (+TIH)
Sjælden (kan forekomme hos op til 1 ud af 1.000 patienter): - Som en konsekvens af lave calcium-værdier: Uregelmæssig hjerterytme (hjertearytmi; sekundære symptomer på hypokalcæmi).
As a consequence of low calcium values: irregular heart beat (cardiac arrhythmia; secondary to hypocalcaemia).
Effektresultaterne kan ses i tabel 4.
Efficacy results are provided in Table 4.
- Overfølsomhed over for det aktive stof, over for andre bisfosfonater eller over for et eller flere af hjælpestofferne anført i pkt.
- Hypersensitivity to the active substance, to any bisphosphonates or to any of the excipients listed in section 6.1.
Børn og unge Zoledronsyre Hospira bør ikke bruges til børn og unge under 18 år.
Zoledronic Acid Hospira is not recommended for use in adolescents and children below the age of 18 years.
Tabel 2: Effektresultater (patienter med prostatacancer i hormonbehandling) Enhver SRE (+TIH)
Table 2: Efficacy results (prostate cancer patients receiving hormonal therapy) Any SRE (+TIH)
3,3 mg* zoledronsyre
3.3 mg* zoledronic acid
Zoledronsyre Hospira leveres som flydende koncentrat (koncentrat til infusionsvæske, opløsning eller sterilt koncentrat) i et hætteglas.
What Zoledronic Acid Hospira looks like and contents of the pack Zoledronic Acid Hospira is supplied as a liquid concentrate (referred to as a ‘concentrate for solution for infusion' or ‘sterile concentrate') in a vial.
Du må ikke få Zoledronsyre Hospira - hvis du er allergisk over for zoledronsyre, andre bisfosfonater eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6) - hvis du har hypokalcæmi (dvs. du har for lavt indhold af calcium i blodet).
You must not be given Zoledronic Acid Hospira: - if you are allergic to zoledronic acid, other bisphosphonates or any of the other ingredients of this medicine (listed in section 6).
• Amning (se pkt.
•Breast-feeding (see section 4.6).
Mannitol, natriumcitrat og vand til injektionsvæsker.
Mannitol, sodium citrate and water for injections.
3,0 mg* zoledronsyre
3.0 mg* zoledronic acid
- Ud fra et mikrobiologisk synspunkt skal produktet anvendes straks efter åbning.
- From a microbiological point of view, the product should be used immediately.
Hvordan skal Zoledronsyre Hospira opbevares
How Zoledronic Acid Hospira is given
Efter markedsføring af produktet er en bivirkning kaldet osteonekrose i kæben (knogleskade i kæben) blevet set hos patienter behandlet med Zoledronsyre Hospira (zoledronsyre) mod osteoporose.
A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported in the post-marketing setting in patients receiving zoledronic acid for osteoporosis.
- hvis du ammer.
− if you are breast-feeding.
Følgende konventionelle klassifikation er anvendt: Meget almindelig (1/10), almindelig (1/100 til <1/10), ikke almindelig (1/1.000 til <1/100), sjælden (1/10.000 til <1/1.000), meget sjælden
The following conventional classification is used: very common ( 1/10), common ( 1/100 to <1/10), uncommon ( 1/1,000 to <1/100), rare ( 1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Hvis opløsningen opbevares i køleskab, skal den tempereres til stuetemperatur inden administration.
If refrigerated, allow the refrigerated solution to reach room temperature before administration.
Bradykardi, hjertearytmi (sekundært til hypokalcæmi) Luftveje, thorax og mediastinum Ikke almindelig:
Bradycardia, cardiac arrhythmia (secondary to hypocalcaemia) Respiratory, thoracic and mediastinal disorders Uncommon: Dyspnoea, cough, bronchoconstriction Rare
Almindelig Atrieflimren Ikke almindelig
Common Atrial fibrillation Uncommon Palpitations
Er du i tvivl, så spørg lægen eller sygeplejersken.
− If you have any further questions, ask your doctor, pharmacist or nurse.
Tabel med liste over bivirkninger
Tabulated list of adverse reactions
Effektresultaterne kan ses i tabel 3.
Efficacy results are provided in Table 3.
Sjældne (kan forekomme hos op til 1 ud af 1.000 patienter) Usædvanlige brud på lårbensknoglen, primært hos patienter i langtidsbehandling for osteoporose, kan forekomme i sjældne tilfælde.
Unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely.
For at undgå eventuelle uforligeligheder skal der som infusionsvæske til fortynding enten bruges natriumchlorid 9 mg/ml (0,9%) opløsning til injektion eller 5% w/v glucoseopløsning.
To avoid potential incompatibilities, the infusion solution used for dilution must be either sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution.
Kun til engangsbrug.
− For single use only.
Andel af patienter med SRE'er p-værdi Mediantid til SRE (dage)
p-value Median time to SRE (days)
Efter første åbning: Ud fra et mikrobiologisk synspunkt skal opløsningen til infusion anvendes straks.
After first opening: From a microbiological point of view, the product should be used immediately.
Én ml koncentrat indeholder 0,8 mg zoledronsyre (som monohydrat).
One ml concentrate contains 0.8 mg zoledronic acid (as monohydrate).
Overvågning
Monitoring test
- Øvrige indholdsstoffer: mannitol, natriumcitrat, natriumchlorid og vand til injektionsvæsker.
− The other ingredients are: mannitol, sodium citrate, sodium chloride and water for injections.
Interstitiel lungesygdom
Musculoskeletal pain
Osteonekrose af kæberne er blevet rapporteret efter markedsføring hos patienter behandlet med zoledronsyre for osteoporose (se pkt.
ONJ has been reported in the post-marketing setting in patients receiving zoledronic acid for osteoporosis (see section 4.8).
5.1) var den generelle forekomst af atrieflimren 2,5% (96 ud af 3.852) og 1,9% (75 ud af 3.852) hos patienter, som fik henholdsvis zoledronsyre og placebo.
In the HORIZON - Pivotal Fracture Trial [PFT] (see section 5.1), the overall incidence of atrial fibrillation was 2.5% (96 out of 3,862) and 1.9% (75 out of 3,852) in patients receiving zoledronic acid and placebo, respectively.
Almindelig (kan forekomme hos op til 1ud af 10 patienter): - Svært nedsat nyrefunktion (vil normalt blive afgjort af din læge ved hjælp af en speciel type blodprøver).
− Severe kidney impairment (will normally be determined by your doctor with certain specific blood tests).
Zoledronsyre Hospira 4 mg/5 ml koncentrat til infusionsvæske, opløsning Zoledronsyre
Zoledronic Acid Hospira 4 mg/5 ml concentrate for solution for infusion Zoledronic acid
Zoledronsyre er kontraindikeret hos kvinder, der ammer (se pkt.
Zoledronic acid is contraindicated in breast-feeding women (see section 4.3).
<10% af maksimalkoncentrationen efter 4 timer og <1% af maksimalkoncentrationen efter 24 timer, med en efterfølgende forlænget periode med meget lave koncentrationer der ikke overstiger 0,1% af den maksimale koncentration inden den 2. infusion af zoledronsyre på dag 28.
After initiating the infusion of zoledronic acid, the plasma concentrations of zoledronic acid rapidly increased, achieving their peak at the end of the infusion period, followed by a rapid decline to < 10% of peak after 4 hours and < 1% of peak after 24 hours, with a subsequent prolonged period of very low concentrations not exceeding 0.1% of peak prior to the second infusion of zoledronic acid on day 28.
Zoledronsyre Hospira er en klar, farveløs opløsning.
What Zoledronic Acid Hospira looks like and contents of the pack Zoledronic Acid Hospira is a clear and colourless solution.
- Det uåbnede hætteglas kræver ingen særlige forholdsregler vedrørende opbevaringen.
− The unopened vial does not require any specific storage conditions.
Tabel 5: Effektresultater (patienter med brystcancer eller multipelt myelom) Enhver SRE (+TIH)
Table 5: Efficacy results (breast cancer and multiple myeloma patients)
Et hætteglas med 5 ml koncentrat indeholder 4 mg zoledronsyre (som monohydrat).
One vial with 5 ml concentrate contains 4 mg zoledronic acid (as monohydrate).