natgillin/translations-raw huggingface dataset:
Der skal udvises forsigtighed, når Zoledronsyre Accord gives sammen med lægemidler, der vides at forårsage hypokalcæmi, da de kan have en synergistisk effekt, resulterende i svær hypokalcæmi (se pkt 4.5).
Caution is advised when Zolendronc Acid Accord is administered with medicinal products known to cause hypocalcaemia, as they may have a synergistic effect resulting in severe hypocalcaemia (see section 4.5).
Nedsat indhold af calcium i blodet (hypokalcæmi), som kan medføre muskelkramper, tør hud, en brændende følelse, er indberettet for patienter i behandling med Zoledronsyre Accord.
Reduced levels of calcium in the blood (hypocalcaemia), sometimes leading to muscle cramps, dry skin, burning sensation, have been reported in patients treated with Zoledronic Acid Accord.
Smerte i ekstremiteter, artralgi, muskuloskeletal smerte
Pain in extremities, arthralgia, musculoskeletal pain
Mediantid til recidiv (fornyet stigning af albuminkorrigeret serumcalcium ≥ 2,9 mmol/l) var 30-40 dage for patienter i behandling med zoledronsyre i forhold til 17 dage for patienter i behandling med 90 mg pamidronat (p-værdier: 0,001 for 4 mg og 0,007 for 8 mg zoledronsyre).
Median time to relapse (re-increase of albumin-corrected serum calcium ≥ 2.9 mmol/l) was 30 to 40 days for patients treated with zoledronic acid versus 17 days for those treated with pamidronate 90 mg (p-values: 0.001 for 4 mg and 0.007 for 8 mg zoledronic acid).
- 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.
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med referencelægemidlet i alle undergrupper af den pædiatriske population ved behandling af tumorinduceret hyperkalcæmi (TIH) og forebyggelse af skeletrelaterede hændelser hos patienter med fremskreden malign sygdom og knoglemetastaser (se pkt.
The European Medicines Agency has waived the obligation to submit the results of studies with the reference product containing zoledronic acid in all subsets of the paediatric population in the treatment of tumour-induced hypercalcaemia and prevention of skeletal-related events in patients with advanced malignancies involving bone (see section 4.2 for information on paediatric use).
Zoledronsyre bør kun genoptages, når serum-kreatinin igen er inden for 10
Zoledronic acid should only be resumed when serum creatinine returns to within 10% of baseline.
Opbevaringsbetingelser for den rekonstituerede infusionsvæske, se pkt.
For storage conditions of the reconstituted solution for infusion, see section 6.3.
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 zoledronsyre (se også afsnit 4.4):
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 zoledronic acid dose is recommended (see also section 4.4):
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/834/001
MARKETING AUTHORISATION NUMBERS EU/1/13/834/001
I et andet studie inkluderende andre solide tumorer end bryst- eller prostatacancer, reducerede zoledronsyre 4 mg signifikant andelen af patienter med SRE'er, forsinkede gennemsnitstiden til første SRE med > 2 måneder og reducerede den skeletale morbiditets rate.
In a second study including solid tumours other than breast or prostate cancer, zoledronic acid 4 mg significantly reduced the proportion of patients with an SRE, delayed the median time to first SRE by > 2 months, and reduced the skeletal morbidity rate.
hvis du har eller har haft smerte, hævelse eller fornemmelse af følelsesløshed i kæben, følelsen af tyngde i kæben eller af løse tænder.
• if you have or have had pain, swelling or numbness of the jaw, a feeling of heaviness in the jaw or loosening of a tooth.
Der tilrådes forsigtighed, når zoledronsyre 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.
Caution is advised when zoledronic acid 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.
Patienternes hydreringsstatus skal vurderes før og efter indgivelsen af Zoledronsyre Accord for at sikre, de er tilstrækkeligt hydrerede.
The hydration status of patients must be assessed prior to and following administration of Zoledronic Acid Accord to ensure that they are adequately hydrated.
Fortæl det straks til din læge eller tandlæge, hvis du får sådanne symptomer, mens du er i behandling med Zoledronsyre Accord eller efter behandlingsophør.
Tell your doctor and dentist immediately if you experience such symptoms while being treated with Zoledronic Acid Accord or after stopping treatment.
LISTE OVER HJÆLPESTOFFER Hjælpestoffer: mannitol (E421), natriumcitrat og vand til injektionsvæske.
Excipients: mannitol (E421), sodium citrate and water for injections.
Instruktion i fremstilling af reducerede doser Zoledronsyre Accord Udtag en passende volumen af det nødvendige koncentrat som følger: 4,4 ml til 3,5 mg dosis
Instructions for preparing reduced doses of Zoledronic Acid Accord Withdraw an appropriate volume of the concentrate needed, as follows: 4.4 ml for 3.5 mg dose
hvis du er allergisk over for zoledronsyre, et andet bisfosfonat (den gruppe af stoffer, som Zoledronsyre Accord tilhører) eller et af de øvrige indholdsstoffer i Zoledronsyre Accord (angivet i punkt 6).
• if you are allergic to zoledronic acid, another bisphosphonate (the group of substances to which Zoledronic Acid Accord belongs), or any of the other ingredients of this medicine
Sløret syn, tåreflåd, lysfølsomhed i øjnene.
• Blurred vision, tearing of the eye, eye sensitivity to light.
Cancer, følgesygdomme (fx anæmi, koagulationslidelse, infektion), rygning.
Cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking.
Analysen vedrørende gentagne hændelser afslørede en signifikant risikoreduktion på 16 % hos patienter behandlet med zoledronsyre 4 mg sammenlignet med patienter behandlet med pamidronat.
The multiple event analysis revealed a significant risk reduction of 16% in patients treated with zoledronic acid 4 mg in comparison with patients receiving pamidronate.
Brug af anden medicin sammen med Zoledronsyre Accord Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
Other medicines and Zoledronic Acid Accord Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER HÆTTEGLASSETS ETIKET
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL
I en pooled analyse af sikkerhedsdata fra zoledronsyre-registreringsstudier vedrørende forebyggelse af knogle-relaterede hændelser hos patienter med fremskreden malign sygdom, der involverer knoglerne, var frekvensen af bivirkninger med relation til nedsat nyrefunktion, og som formodes at være relateret til zoledronsyre, følgende: 3,2 % ved multipelt myelom, 3,1 % ved prostatacancer, 4,3 % ved brystcancer og 3,2 % ved lunge- og andre solide tumorer.
In a pooled analysis of safety data from zoledronic acid registration trials for the prevention of skeletal-related events in patients with advanced malignancies involving bone, the frequency of renal impairment adverse events suspected to be related to zoledronic acid (adverse reactions) was as follows: multiple myeloma (3.2%), prostate cancer (3.1%), breast cancer (4.3%), lung and other solid tumours (3.2%).
I et 3-års, randomiseret, dobbeltblindet, kontrolleret studie, som evaluerede effekt og sikkerhed af zoledronsyre 5 mg én gang årligt versus placebo ved behandling af postmenopausal osteoporose (PMO), var den generelle forekomst af atrieflimren 2,5 % (96 ud af 3.862) og 1,9 % (75 ud af 3.852) hos patienter, som fik henholdsvis zoledronsyre 5 mg og placebo.
In one 3-year, randomised, double-blind controlled trial that evaluated the efficacy and safety of zoledronic acid 5 mg once yearly vs. placebo in the treatment of postmenopausal osteoporosis (PMO), 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 5 mg and placebo, respectively.
Pludselig opstået kuldefølelse med besvimelse, slaphed eller kollaps.
• Sudden coldness with fainting, limpness or collapse.
Zoledronsyre var teratogen hos rotter i subkutane doser på  0,2 mg/kg.
Zoledronic acid was teratogenic in the rat at subcutaneous doses  0.2 mg/kg.
Den renale clearance af zoledronsyre korrelerer tydeligt med kreatininclearance, idet den renale clearance er ansvarlig for 75  33 % af kreatininclearance, 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.
Hos patienter med let til moderat nedsat nyrefunktion anbefales nedsatte doser af zoledronsyre (se afsnittet ”Dosering” ovenfor samt pkt.
In patients with mild to moderate renal impairment, reduced zoledronic acid doses are recommended (see section “Posology” above and section 4.4).
Serumcalcium bør måles og hypokalcæmi korrigeres, inden behandling med Zoledronsyre Accord påbegyndes.
Serum calcium should be measured and hypocalcaemia must be corrected before initiating Zoledronic Acid Accord therapy.
Fortæl det straks til din læge, hvis du oplever symptomer så som nyopstået ømhed, smerte eller stivhed, eller en forværring af disse symptomer, mens du er i behandling med Zoledronsyre Accord eller efter endt behandling.
Tell your doctor immediately if you experience symptoms such as new onset or worsening of aches, pain or stiffness while being treated with Zoledronic Acid Accord or after stopping treatment.
Aktivt stof: zoledronsyre.
• The active substance is zoledronic acid.
55,6 % (p = 0,021)* 83,3 % (p = 0,010)* 86,7 % (p = 0,015)* Pamidronat 90 mg (N = 99) 33,3 % * p-værdier sammenlignet med pamidronat.
Zoledronic acid 4 mg (N=86) 45.3% (p=0.104) 82.6% (p=0.005)* 88.4% (p=0.002)* Zoledronic acid 8 mg (N=90) 55.6% (p=0.021)* 83.3% (p=0.010)* 86.7% (p=0.015)* Pamidronate 90 mg (N=99) *p-values compared to pamidronate.
- Der er i meget sjældne tilfælde set osteonekrose af andre knogler end kæben, særligt af hoften eller låret.
• Osteonecrosis has also very rarely been seen occurring with other bones than the jaw, especially the hip or thigh.
Det er især vigtigt, at du fortæller lægen, hvis du også får: - Aminoglykosider (en type medicin til behandling af alvorlige infektioner), calcitonin (en type medicin til behandling knogleskørhed efter menopausen og til for højt calcium), slyngediuretika (vanddrivende medicin til behandling af forhøjet blodtryk eller væskesamlinger) eller anden medicin, der sænker calcium, da kombinationen af disse stoffer og bisfosfonater kan forårsage, at blodets indhold af calcium bliver for lavt.
• Aminoglycosides (medicines used to treat severe infections), calcitonin (a type of medicine used to treat post-menopausal osteoporosis and hypercalcaemia), loop diuretics (a type of medicine to treat high blood pressure or oedema) or other calcium-lowering medicines, since the combination of these with bisphosphonates may cause the calcium level in the blood to become too low.
- Uregelmæssig hjerterytme (atrieflimren) er set hos patienter, der fik zoledronsyre for postmenopausal osteoporose.
• Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving zoledronic acid for postmenopausal osteoporosis.
Zoledronsyre Accord må kun udskrives og administreres til patienter af sundhedspersonale med erfaring i administration af intravenøse bisfosfonater.
4.2 Posology and method of administration Zoledronic Acid Accord must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates.
4.2), bør derfor overvåges nøje, eftersom nedsat nyrefunktion (inklusiv nyresvigt) og serum-elektrolyt (inklusiv calcium, fosfor og magnesium) forstyrrelser er blevet observeret.
Patients who have received doses higher than those recommended (see section 4.2) should be carefully monitored, since renal function impairment (including renal failure) and serum electrolyte (including calcium, phosphorus and magnesium) abnormalities have been observed.
INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 5 ml
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
- Sig det til lægen, hvis du får øresmerter, udflåd fra øret og/eller betændelse i øret.
• Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.
Du bør ikke få Zoledronsyre Accord, hvis du er gravid.
You should not be given Zoledronic Acid Accord if you are pregnant.
Hjertearytmi og neurologiske bivirkninger (herunder kramper, hypæstesi og tetani) er blevet rapporteret sekundært til tilfælde af alvorlig hypokalcæmi.
Cardiac arrhythmias and neurologic adverse events (including convulsions, hypoasthesia and tetany) have been reported secondary to cases of severe hypocalcaemia.
Skeletal morbiditets rate p-værdi
p-value Skeletal morbidity rate p-value
Når du skal tilberede en infusionsvæske indeholdende 4 mg zoledronsyre, skal du fortynde Zoledronsyre Accord-koncentratet (5 ml) yderligere med 100 ml infusionsvæske, som er calciumfri eller fri for andre divalente kationer.
• To prepare an infusion solution containing 4 mg zoledronic acid, further dilute the Zoledronic Acid Accord concentrate (5ml) with 100 ml of calcium-free or other divalent cation-free infusion solution.
Tabel 4: Effektresultater (patienter med brystcancer eller multipelt myelom)
Table 4: Efficacy results (breast cancer and multiple myeloma patients) Any SRE (+TIH)
Anbefalet dosis af zoledronsyre* 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).
Baseline creatinine clearance (ml/min) Zoledronic acid 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).
Sjælden (forekommer hos op til 1 ud af 1.000 patienter):
Rare (may affect up to 1 in 1,000 people):
- 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, diarrhoea constipation,
EU/1/13/834/001- 1 hætteglas EU/1/13/834/002- 4 hætteglas EU/1/13/834/003- 10 hætteglas
MARKETING AUTHORISATION NUMBER(S) EU/1/13/834/001- 1vial pack EU/1/13/834/002- 4 vial pack EU/1/13/834/003- 10 vial pack
I kliniske forsøg med zoledronsyre blev patienter med serum-kreatinin > 265 mol/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.
Opløsningen indeholdende zoledronsyre indgives ved en enkelt intravenøs infusion over 15 minutter i en separat infusionsslange.
• The solution containing zoledronic acid is given as a single 15-minute intravenous infusion in a separate infusion line.
Anvendes straks efter fortynding.
EXP Use immediately after dilution.
Tabel 3: Effektresultater (solide tumorer udover bryst- og prostatacancer)
Table 3: Efficacy results (solid tumours other than breast or prostate cancer) Any SRE (+TIH)
Voksne og ældre
Children and adolescents
anvendelse efter fortynding
use after dilution
Tandsygdom i anamnesen, dårlig mundhygiejne, parodontal sygdom, invasiv tandbehandling (fx tandudtrækninger) og dårligt tilpassede tandproteser.
History of dental disease, poor oral hygiene, periodontal disease, invasive dental procedures (e.g. tooth extractions) and poorly fitting dentures
Det er ikke nødvendigt at dosisjustere patienter med TIH og serum-kreatinin < 400 μmol/l eller < 4,5 mg/dl (se afsnit 4.4).
No dose adjustment is necessary in TIH patients with serum creatinine < 400 µmol/l or < 4.5 mg/dl (see section 4.4).
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Zoledronsyre Accord 4 mg/5 ml sterilt koncentrat zoledronsyre
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Zoledronic Acid Accord 4 mg/5 ml sterile concentrate zoledronic acid
Forværring af nyrefunktion blev i kliniske studier defineret som følger: 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).
In the clinical trials, renal deterioration was defined as follows: 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; 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.
- Langsom hjerterytme.
• Slow heart beat.
Indehaveren af markedsføringstilladelsen skal sikre, at der implementeres patienthuskekort vedrørende osteonekrose af kæberne.
The MAH shall ensure that a patient reminder card regarding osteonecrosis of the jaw is implemented.
- Mave-tarm-symptomer såsom kvalme og opkastning samt appetitløshed.
• Gastrointestinal reactions such as nausea and vomiting as well as loss of appetite.
Analyser af gentagne hændelser viste risikoreduktion på 30,7 % i udviklingen af skeletrelaterede hændelser i zoledronsyre 4 mggruppen sammenlignet med placebo.
Multiple event analysis showed 30.7% risk reduction in developing SREs in the zoledronic acid 4 mg group compared with placebo.
Det skal du vide, før du begynder at bruge Zoledronsyre Accord 3.
What you need to know before you are given Zoledronic Acid Accord 3.
Patienter i behandling med Zoledronsyre Accord bør få udleveret indlægssedlen og patienthuskekortet.
Patients treated with Zoledronic Acid Accord should be given the package leaflet and the patient reminder card. Posology
Zoledronsyre Accord indeholder natrium
Zoledronic Acid Accord contains sodium
Zoledronsyre Accord indeholder
What Zoledronic Acid Accord contains
6.6 Regler for bortskaffelse og anden håndtering Før administration skal 5 ml koncentrat fra et hætteglas eller den påkrævede mængde udtagne koncentrat fortyndes yderligere med 100 ml calciumfri infusionsvæske (0,9 % w/v natriumkloridopløsning til injektionsvæske eller 5 % w/v glucoseopløsning).
Prior to administration, 5ml 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 for Injection or 5% w/v glucose solution).
In vivo: Hæmning af osteoklastisk knogleresorption, hvilket ændrer knoglemarvens mikromiljø og mindsker bidraget til tumorcellevæksten, den anti-angiogenetiske aktivitet og anti-smerte aktiviteten.
The following properties have been demonstrated in preclinical studies: In-vivo: Inhibition of osteoclastic bone resorption, which alters the bone marrow microenvironment, making it less conducive to tumour cell growth, anti-angiogenic activity and anti-pain activity.
Osteonekrose af kæberne er blevet rapporteret med frekvensen ”ikke almindelig” i kliniske forsøg og efter markedsføring hos patienter behandlet med Zoledronsyre Accord.
Osteonecrosis of the jaw (ONJ) has been reported uncommonly in clinical trials and in the postmarketing setting in patients receiving Zoledronic Acid Accord
Zoledronsyre Accord-koncentrat må ikke blandes med calcium eller anden divalent kationholdig infusionsopløsning såsom Ringer-lactatopløsning, og bør indgives som en enkelt intravenøs opløsning i en separat infusionsslange.
Zoledronic Acid Accord concentrate 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.
Meget almindelig ( 1/10)
Very common (1/10)
Meget almindelig (1/10)
Very common ( 1/10)
Den udtagne mængde af koncentrat skal fortyndes yderligere i 100 ml sterilt 0,9 % w/v natriumchlorid- eller 5 % w/v glucoseinjektions-/infusionsvæske.
The withdrawn amount of concentrate must be further diluted in 100 ml of sterile 0.9% w/v sodium chloride solution or 5% w/v glucose solution.
- Influenza-lignende symptomer herunder gigt (artitis) og hævede led.
• Flu-like symptoms including arthritis and joint swelling.
Analyser af gentagne hændelser viste risikoreduktion på 36 % i udviklingen af skeletrelaterede hændelser i zoledronsyre 4 mg-gruppen sammenlignet med placebo.
Multiple event analysis showed a 36% risk reduction in developing SREs in the zoledronic acid 4 mg group compared with placebo.
Zoledronsyre Accord-koncentrat må ikke blandes med calciumholdige opløsninger eller andre opløsninger indeholdende divalente kationer som lakteret Ringers væske.
Do not mix Zoledronic Acid Accord concentrate with calcium-containing or other divalent cation-containing solutions such as lactated Ringer's solution.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Et hætteglas med 5 ml koncentrat indeholder 4 mg zoledronsyre (som monohydrat).
QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 5 ml concentrate contains 4 mg zoledronic acid (as monohydrate) One ml concentrate contains 0.8 mg zoledronic acid (as monohydrate).
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.
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).
Det skal du vide, før du begynder at bruge Zoledronsyre Accord
What you need to know before you are given Zoledronic Acid Accord
Almindelig ( 1/100 til < 1/10)
Common ( 1/100 to < 1/10)
Sjælden ( 1/10.000 til < 1/1.000)
Rare ( 1/10.000 to < 1/1.000)
Tabel 2: Effektresultater (patienter med prostatacancer i hormonbehandling)
Table 2: Efficacy results (prostate cancer patients receiving hormonal therapy) Any SRE (+TIH)
- Hudreaktioner (rødme og hævelse) på infusionsstedet, udslæt, kløe.
• Skin reactions (redness and swelling) at the infusion site, rash, itching.
Mens du er i behandling med Zoledronsyre Accord, skal du holde en god mundhygiejne (inkl.
While being treated with Zoledronic Acid Accord, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Zoledronsyre Accord 4 mg/5 ml koncentrat til infusionsvæske, opløsning zoledronsyre
Zoledronic Acid Accord 4 mg/5 ml concentrate for solution for infusion zoledronic acid
For at forhindre eventuelle uforligeligheder skal Zoledronsyre Accord-koncentrat fortyndes med 0,9 % w/v natriumklorid- eller 5 % w/v glucoseinjektions-/infusionsvæske.
To avoid potential incompatibilities, Zoledronic Acid Accord concentrate is to be diluted with 0.9% w/v sodium chloride solution for Injection or 5% w/v glucose solution.
I kliniske forsøg blev patienter med serum-kreatinin > 400 μmol/l eller > 4,5 mg/dl ekskluderet.
In the clinical studies, patients with serum creatinine > 400 µmol/l or > 4.5 mg/dl were excluded.
Vejrtrækningsbesvær med hiven efter vejret eller hosten.
• Difficulty in breathing with wheezing or coughing.