natgillin/translations-raw huggingface dataset:
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 Zoledronsyre Hospira (se også pkt. 
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 Zoledronic Acid Hospira doses are recommended (see also section 4.4).
Dialysekrævende nyresvigt eller letale tilfælde er i sjældne tilfælde opstået hos patienter med underliggende nyresygdom eller med en af risikofaktorerne beskrevet ovenfor. 
Renal impairment has been observed in patients after a single administration, renal failure requiring dialysis or with a fatal outcome has rarely occurred in patients with underlying renal impairment or with any of the risk factors described above.
Tilpasset dosis (mg zoledronsyre) 
Adjusted dose (mg zoledronic acid)
- Ud fra et mikrobiologisk synspunkt skal den rekonstituerede opløsning til infusion anvendes straks. 
− From a microbiological point of view, the diluted solution for infusion should be used immediately.
- 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.
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.
Denne medicin indeholder mindre end 1 mmol (23 mg) natrium pr. 100 ml Zoledronsyre Hospira, dvs. den er i det væsentlige natriumfri. 
This medicinal product contains less than 1 mmol sodium (23 mg) per 100 ml dose of Zoledronic Acid Hospira, i.e. essentially “sodium free”.
• Før hver dosis Zoledronsyre Hospira bør kreatinin clearance beregnes på bais af den faktiske legemsvægt ved at bruge Cockcroft-Gault formlen. 
• Creatinine clearance should be calculated based on actual body weight using the Cockcroft-Gault formula before each Zoledronic Acid Hospira dose.
Hvis du har hypokalcæmi, skal den korrigeres, inden du får den første dosis af Zoledronsyre Hospira. 
If you have pre-existing hypocalcaemia, it must be corrected before initiating the first dose of Zoledronic Acid Hospira.
Zoledronsyre Hospira er kontraindiceret under gravididitet (se pkt.4.3). 
Zoledronic Acid Hospira is contraindicated during breast-feeding (see section 4.3).
Nakkesmerter, stivhed i bevægeapparatet, hævelse af led, muskelkramper, skuldersmerter, muskuloskeletale smerter i brystregionen, muskuloskeletale smerter, ledstivhed, artrit, muskelsvækkelse 
Uncommon Neck pain, musculoskeletal stiffness, joint swelling, muscle spasms, shoulder pain, musculoskeletal chest pain, musculoskeletal pain, joint stiffness, arthritis, muscular weakness
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).
-Posen kræver ikke særlige opbevaringsbetingelser. 
− The bag does not require any specific storage conditions.
Tabel 1: Tilberedning af nedsatte doser af Zoledronsyre Hospira 4 mg/100 ml, infusionsvæske, opløsning 
Table 1: Preparation of reduced doses of Zoledronic Acid Hospira 4 mg/100 ml solution for infusion
Hos patienter med let til moderat nedsat nyrefunktion, anbefales nedsatte doser af Zoledronsyre Hospira (se afsnittet ”Dosering” ovenfor samt pkt. 
In patients with mild to moderate renal impairment, reduced Zoledronic Acid Hospira doses are recommended (see section “Posology” above and section 4.4).
Fortæl det straks til din læge eller tandlæge, hvis du får sådanne symptomer, mens du er i behandling med Zoledronsyre Hospira eller efter behandlingsophør. 
Tell your doctor or dentist immediately if you experience such symptoms while being treated with Zoledronic Acid Hospira or after stopping treatment.
Almindelig Hypokalcæmi* Ikke almindelig 
Common Hypocalcaemia* Uncommon Decreased appetite Rare
Kontakt straks din læge og tandlæge, hvis du oplever sådanne symptomer, men du er i behandling med Zoledronsyre Hospira, eller efter at behandlingen er stoppet. 
Tell your doctor and dentist immediately if you experience such symptoms while being treated with Zoledronic Acid Hospira or after stopping treatment.
Hvis du har hypokalcæmi, skal den korrigeres, inden du får den første dosis af zoledronsyre. 
If you have pre-existing hypocalcaemia, it must be corrected before initiating the first dose of Zoledronic acid.
Dyreforsøg har påvist reproduktionstoksicitet (se pkt. 
Animal reproduction studies with zoledronic acid have shown reproductive toxicity (see section 5.3).
- Patienter med hypokalcæmi (se pkt. 
- Patients with hypocalcaemia (see section 4.4).
Indeholder også mannitol, natriumcitrat, vand til injektionsvæsker og natriumchlorid. 
It also contains mannitol, sodium citrate, water for injections and sodium chloride.
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 zoledronsyre (se også pkt. 
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):
Patienter i behandling med Zoledronsyre Hospira bør få udleveret indlægssedlen og patienthuskekortet. 
Patients treated with Zoledronic Acid Hospira should be given the package leaflet and the patient reminder card
- hvis du er under tandlægebehandling eller skal have en tandoperation, bør du fortælle tandlægen, atdu eribehandlingmed ZoledronsyreHospiraog informere din læge om tandlægebehandlingen. 
- if you are having dental treatment or are due to undergo dental surgery, tell your dentist that you are being treated with Zoledronic Acid Hospira and inform your doctor about your dental treatment.
Brug af Zoledronsyre Hospira sammen med mad og drikke Sørg for at drikke tilstrækkelig væske (mindst 1 eller 2 glas) før og efter behandling med Zoledronsyre Hospira, som din læge har fortalt dig. 
Make sure you drink enough fluids (at least one or two glasses) before and after the treatment with Zoledronic Acid Hospira, as directed by your doctor.
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.