FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: 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.
English: Table 4: Efficacy results (breast cancer and multiple myeloma patients) Any SRE (+TIH)
Danish: Tabel 4: Effektresultater (patienter med brystcancer eller multipelt myelom) Enhver SRE (+TIH)
English: Zoledronic Acid Hospira is supplied as packs containing one bag.
Danish: Zoledronsyre Hospira leveres i pakninger indeholdende én pose.
English: CARTON FOR 1 VIAL AS UNIT PACK
Danish: KARTON TIL 1 HÆTTEGLAS SOM ENKELTPAKNING
English: 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.
Danish: Zoledronsyre udviser ingen mærkbar binding til plasmaproteiner og hæmmer ikke de humane P450-enzymer in vitro (se pkt.
English: 3.5 mg* zoledronic acid
Danish: 3,5 mg* zoledronsyre
English: Blood creatinine and blood urea increased, hypocalcaemia Uncommon: Hypomagnesaemia, hypokalaemia Rare:
Danish: Almindelig: Øget serum kreatinin og serumurea, hypokalcæmi Ikke almindelig:
English: 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.
Danish: 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.
English: - This product does not require any special storage conditions.
Danish: - Dette produkt kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: - 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.
Danish: 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.
English: How to prepare and administer Zoledronic Acid Hospira
Danish: Tilberedelse og administration af Zoledronsyre Hospira:
English: What Zoledronic Acid Hospira 5 mg/100 ml solution for infusion contains - The active substance is zoledronic acid.
Danish: Pakningsstørrelser og yderligere oplysninger Zoledronsyre Hospira 5 mg/100 ml infusionsopløsning indeholder: - Aktivt stof: zoledronsyre.
English: Efficacy results are provided in Table 2.
Danish: Effektresultaterne kan ses i tabel 2.
English: Tell your doctor about any of the following serious side effects straight away:
Danish: Giv straks din læge besked, hvis du bemærker en eller flere af nedenstående bivirkninger:
English: Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) and other anatomical sites including femur and hip Renal and urinary disorders Common:
Danish: Osteonekrose af øregangen (klassebivirkning for bisfosfonater) og andre anatomiske steder inklusiv femur og hoften
English: While being treated with Zoledronic Acid Hospira, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Danish: Mens du er i behandling med Zoledronsyre Hospira, skal du holde en god mundhygiejne (inkl.
English: Abdominal pain Musculoskeletal and connective tissue disorders Common:
Danish: Abdominalsmerter Knogler, led, muskler og bindevæv Almindelig:
English: 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.
Danish: For at forhindre eventuelle uforligeligheder skal Zoledronsyre Hospira fortyndes med natriumklorid 9 mg/ml (0,9% ) opløsning til injektion eller 5% w/v glukoseopløsning.
English: - For single use only.
Danish: - Kun til engangsbrug.
English: Renal function impairment, osteonecrosis of the jaw, acute phase reaction, hypocalcaemia, atrial fibrillation, anaphylaxis, Interstitial lung disease.
Danish: Nedsat nyrefunktion, osteonekrose af kæberne, akut fasereaktion, hypokalcæmi, atrieflimren, anafylaksi, interstitiel lungesygdom.
English: You must not be given Zoledronic Acid Hospira if you are breast-feeding.
Danish: Du må ikke få Zoledronsyre Hospira, hvis du ammer.
English: Table 3: Efficacy results (solid tumours other than breast or prostate cancer) Any SRE (+TIH)
Danish: Tabel 3: Effektresultater (solide tumorer udover bryst- og prostatacancer) Enhver SRE (+TIH)
English: 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
Danish: Asteni, perifere ødemer, reaktioner ved injektionsstedet (inklusive smerter, irritation, hævelse, induration), brystsmerter, vægtøgning, anafylaktisk reaktion/shock, urticaria
English: 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.
Danish: 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.
English: - Poor oral hygiene, periodontal disease, poorly fitting dentures, history of dental disease, invasive dental procedures, e.g. tooth extractions.
Danish: - Dårlig mundhygiejne, parodontal sygdom, dårligt tilpassede tandproteser, tandsygdom i anamnesen, invasiv tandbehandling fx udtrækning af en tand.
English: Table 4: Efficacy results (solid tumours other than breast or prostate cancer) Any SRE (+TIH)
Danish: Tabel 4: Effektresultater (solide tumorer udover bryst- og prostatacancer) Enhver SRE (+TIH)
English: As a consequence of low calcium values: irregular heart beat (cardiac arrhythmia; secondary to hypocalcaemia).
Danish: 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).
English: Efficacy results are provided in Table 4.
Danish: Effektresultaterne kan ses i tabel 4.
English: - Hypersensitivity to the active substance, to any bisphosphonates or to any of the excipients listed in section 6.1.
Danish: - Overfølsomhed over for det aktive stof, over for andre bisfosfonater eller over for et eller flere af hjælpestofferne anført i pkt.
English: Zoledronic Acid Hospira is not recommended for use in adolescents and children below the age of 18 years.
Danish: Børn og unge Zoledronsyre Hospira bør ikke bruges til børn og unge under 18 år.
English: Table 2: Efficacy results (prostate cancer patients receiving hormonal therapy) Any SRE (+TIH)
Danish: Tabel 2: Effektresultater (patienter med prostatacancer i hormonbehandling) Enhver SRE (+TIH)
English: 3.3 mg* zoledronic acid
Danish: 3,3 mg* zoledronsyre
English: 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.
Danish: Zoledronsyre Hospira leveres som flydende koncentrat (koncentrat til infusionsvæske, opløsning eller sterilt koncentrat) i et hætteglas.
English: 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).
Danish: 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).
English: •Breast-feeding (see section 4.6).
Danish: • Amning (se pkt.
English: Mannitol, sodium citrate and water for injections.
Danish: Mannitol, natriumcitrat og vand til injektionsvæsker.
English: 3.0 mg* zoledronic acid
Danish: 3,0 mg* zoledronsyre
English: - From a microbiological point of view, the product should be used immediately.
Danish: - Ud fra et mikrobiologisk synspunkt skal produktet anvendes straks efter åbning.
English: How Zoledronic Acid Hospira is given
Danish: Hvordan skal Zoledronsyre Hospira opbevares
English: 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.
Danish: 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.
English: − if you are breast-feeding.
Danish: - hvis du ammer.
English: 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).
Danish: 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
English: If refrigerated, allow the refrigerated solution to reach room temperature before administration.
Danish: Hvis opløsningen opbevares i køleskab, skal den tempereres til stuetemperatur inden administration.
English: Bradycardia, cardiac arrhythmia (secondary to hypocalcaemia) Respiratory, thoracic and mediastinal disorders Uncommon: Dyspnoea, cough, bronchoconstriction Rare
Danish: Bradykardi, hjertearytmi (sekundært til hypokalcæmi) Luftveje, thorax og mediastinum Ikke almindelig:
English: Common Atrial fibrillation Uncommon Palpitations
Danish: Almindelig Atrieflimren Ikke almindelig
English: − If you have any further questions, ask your doctor, pharmacist or nurse.
Danish: Er du i tvivl, så spørg lægen eller sygeplejersken.
English: Tabulated list of adverse reactions
Danish: Tabel med liste over bivirkninger
English: Efficacy results are provided in Table 3.
Danish: Effektresultaterne kan ses i tabel 3.
English: Unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely.
Danish: 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.
English: 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.
Danish: 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.
English: − For single use only.
Danish: Kun til engangsbrug.
English: p-value Median time to SRE (days)
Danish: Andel af patienter med SRE'er p-værdi Mediantid til SRE (dage)
English: After first opening: From a microbiological point of view, the product should be used immediately.
Danish: Efter første åbning: Ud fra et mikrobiologisk synspunkt skal opløsningen til infusion anvendes straks.
English: One ml concentrate contains 0.8 mg zoledronic acid (as monohydrate).
Danish: Én ml koncentrat indeholder 0,8 mg zoledronsyre (som monohydrat).
English: Monitoring test
Danish: Overvågning
English: − The other ingredients are: mannitol, sodium citrate, sodium chloride and water for injections.
Danish: - Øvrige indholdsstoffer: mannitol, natriumcitrat, natriumchlorid og vand til injektionsvæsker.
English: Musculoskeletal pain
Danish: Interstitiel lungesygdom
English: ONJ has been reported in the post-marketing setting in patients receiving zoledronic acid for osteoporosis (see section 4.8).
Danish: Osteonekrose af kæberne er blevet rapporteret efter markedsføring hos patienter behandlet med zoledronsyre for osteoporose (se pkt.
English: 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.
Danish: 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.
English: − Severe kidney impairment (will normally be determined by your doctor with certain specific blood tests).
Danish: 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).
English: Zoledronic Acid Hospira 4 mg/5 ml concentrate for solution for infusion Zoledronic acid
Danish: Zoledronsyre Hospira 4 mg/5 ml koncentrat til infusionsvæske, opløsning Zoledronsyre
English: Zoledronic acid is contraindicated in breast-feeding women (see section 4.3).
Danish: Zoledronsyre er kontraindikeret hos kvinder, der ammer (se pkt.
English: 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.
Danish: <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.
English: What Zoledronic Acid Hospira looks like and contents of the pack Zoledronic Acid Hospira is a clear and colourless solution.
Danish: Zoledronsyre Hospira er en klar, farveløs opløsning.
English: − The unopened vial does not require any specific storage conditions.
Danish: - Det uåbnede hætteglas kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: Table 5: Efficacy results (breast cancer and multiple myeloma patients)
Danish: Tabel 5: Effektresultater (patienter med brystcancer eller multipelt myelom) Enhver SRE (+TIH)
English: One vial with 5 ml concentrate contains 4 mg zoledronic acid (as monohydrate).
Danish: Et hætteglas med 5 ml koncentrat indeholder 4 mg zoledronsyre (som monohydrat).
English: Nausea, vomiting, decreased appetite Uncommon: Diarrhoea, constipation, abdominal pain, dyspepsia, stomatitis, dry mouth Skin and subcutaneous tissue disorders Uncommon: Pruritus, rash (including erythematous and macular rash), increased sweating Musculoskeletal and connective tissue disorders Common:
Danish: Pruritus, udslæt (inklusive erythematøst og makuløst udslæt), øget svedtendens Knogler, led, muskler og bindevæv Almindelig:
English: Check with your doctor or nurse if you are not sure.
Danish: Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er noget, du er i tvivl om.
English: Uncommon Hypertension, flushing Not known**
Danish: Almindelig Hovedpine, svimmelhed Ikke almindelig
English: Patients must be assessed prior to administration of zoledronic acid to ensure that they are adequately hydrated.
Danish: Før indgift af zoledronsyre skal patienterne vurderes med henblik på at sikre, de er vel hydrerede.
English: The use of Zoledronic Acid Hospira in children and adolescents has not been studied.
Danish: Zoledronsyre Hospira frarådes til personer under 18 år, da brug af Zoledronsyre Hospira til børn og unge ikke er undersøgt.
English: Additionally, there have been sporadic reports of osteonecrosis of other sites, including the hip and femur, reported predominantly in adult cancer patients treated with Zoledronic Acid Hospira.
Danish: Derudover har der været sporadiske rapporter om osteonekrose af andre steder, inklusive hoften og femur.
English: − Your doctor will recommend that you drink enough water before each treatment to help prevent dehydration.
Danish: - For at undgå væskemangel vil din læge anbefale at du drikker drikke rigeligt med vand inden behandlingerne.
English: Common Ocular hyperaemia Uncommon Conjunctivitis, eye pain Rare
Danish: Almindelig Okulær hyperæmi Ikke almindelig
English: − The active substance of Zoledronic Acid Hospira 4 mg/100 ml solution for infusion is zoledronic acid.
Danish: Zoledronsyre Hospira indeholder - Aktivt stof: Det aktive stof i Zoledronsyre Hospira 4 mg/100 ml infusionsvæske, opløsning er zoledronsyre.
English: Rare (may affect up to 1 in 1,000 people):
Danish: Sjælden (kan forekomme hos op til 1 ud af 1.000 patienter): -Langsomhjerterytme.
English: - Concomitant therapies: chemotherapy, angiogenesis inhibitors (see section 4.5), radiotherapy to neck and head, corticosteroids.
Danish: 4.5), strålebehandling i nakke og hoved, kortikosteroider.
English: Zoledronic Acid Hospira must not be mixed with other infusion solutions and should be administered as a single intravenous solution in a separate infusion line.
Danish: Zoledronsyre Hospira infusionsvæske, opløsning må ikke blandes med andre infusionsvæsker og bør indgives som en enkelt intravenøs opløsning i en separat infusionsslange.
English: Zoledronic Acid Hospira 4 mg/100 ml solution for infusion Zoledronic acid
Danish: Zoledronsyre Hospira 4 mg/100 ml infusionsvæske, opløsning Zoledronsyre
English: Each bag of 100 ml contains 5 mg zoledronic acid (as monohydrate).
Danish: Hver pose af 100 ml indeholder 5 mg zoledronsyre (som monohydrat).
English: Zoledronic Acid Hospira 5 mg/100 ml (to appear in roundel) solution for infusion Zoledronic acid
Danish: Zoledronsyre Hospira 5 mg/100 ml (vises i en cirkel) infusionsvæske, opløsning Zoledronsyre
English: Zoledronic Acid Hospira 5 mg/100 ml solution for infusion Zoledronic acid
Danish: Zoledronsyre Hospira 5 mg/100 ml infusionsvæske, opløsning Zoledronsyre
English: Zoledronic Acid Hospira 4 mg/100 ml (to appear in roundel) solution for infusion Zoledronic acid
Danish: Zoledronsyre Hospira 4 mg/100 ml (vises i en cirkel) infusionsvæske, opløsning Zoledronsyre
English: Each ml of the solution contains 0.05 mg zoledronic acid anhydrous (as monohydrate).
Danish: Hver ml af opløsningen indeholder 0,05 mg vandigt zoledronsyre (som monohydrat).
English: Hypophosphataemia
Danish: Almindelig: Hypofosfatæmi
English: Zoledronic Acid Hospira is supplied as packs containing 1 vial.
Danish: Zoledronsyre Hospira leveres i pakninger med 1 hætteglas.
English: − The other ingredients are: mannitol, sodium citrate, water for injections.
Danish: - Øvrige indholdsstoffer: mannitol, natriumcitrat, vand til injektionsvæsker.
English: Uncommon (may affect up to 1 in 100 people):
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 patienter): - Overfølsomhedsreaktioner.
English: Cardiac disorders Common:
Danish: Mave-tarm-kanalen Almindelig:
English: Allow the refrigerated solution to reach room temperature before administration.
Danish: Opløsninger, som opbevares i køleskab, skal have stuetemperatur før administration.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted.
Danish: Fritaget fra krav om brailleskrift.
English: - The other ingredients are mannitol, sodium citrate and water for injections.
Danish: - Øvrige indholdsstoffer: mannitol, natriumcitrat og vand til injektionsvæsker.
English: - History of dental disease, poor oral hygiene, periodontal disease, invasive dental procedures
Danish: - Tidligere tandsygdomme, dårlig mundhygiejne, paradentose, invasive tandbehandlinger (fx tandudtrækninger) og dårligt tilpassede tandproteser.
English: Common Nausea, vomiting, diarrhoea Uncommon Dyspepsia, abdominal pain upper, abdominal pain, gastroesophageal reflux disease, constipation, dry mouth, oesophagitis, toothache, gastritis Skin and subcutaneous tissue disorders Uncommon Rash, hyperhidrosis, pruritus, erythema Musculoskeletal and connective tissue Common Myalgia, arthralgia, bone pain, back pain,
Danish: Dyspepsi, øvre mavesmerter, mavesmerter, gastroøsofageal reflukssygdom, forstoppelse, mundtørhed, øsofagit, tandpine, gastrit
English: The following should be considered when evaluating a patient's risk of developing ONJ: - Potency of the medicinal product that inhibits bone resorption (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bone resorption therapy.
Danish: Følgende bør overvejes når risikoen for at udvikle osteonekrose af kæberne skal vurderes hos den enkelte patient: - Styrken af det lægemiddel, der hæmmer knogleresorption (øget risiko ved højpotente stoffer),
English: How to store Zoledronic Acid Hospira
Danish: Sådan får du Zoledronsyre Hospira
English: Eye disorders
Danish: Konjunktivit, øjensmerter
English: − 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.
Danish: - Forhøjet blodtryk, åndenød, svimmelhed, angst, søvnforstyrrelser, smagsforstyrrelser, rysten,
English: Uncommon: Acute renal failure, haematuria, proteinuria Rare
Danish: Akut nyresvigt, hæmaturi, proteinuri
English: One bag with 100 ml contains 4 mg zoledronic acid (as monohydrate).
Danish: En pose med 100 ml indeholder 4 mg zoledronsyre (som monohydrat).
English: Uncommon: Thrombocytopenia, leukopenia Rare:
Danish: Trombocytopeni, leukopeni
English: − Sleepiness
Danish: Natriumcitrat
English: disorders pain in extremity
Danish: Almindelig: Abdominalsmerter
English: Uncommon Influenza, nasopharyngitis
Danish: Influenza, nasofaryngit
English: Renal and urinary disorders
Danish: Nyrer og urinveje Almindelig:
English: One bag contains 4 mg of zoledronic acid (as monohydrate).
Danish: Én pose indeholder 4 mg zoledronsyre (som monohydrat).
English: − if you are allergic (hypersensitive) to zoledronic acid, another bisphosphonate (the group of substances to which zoledronic acid belongs), or any of the other ingredients of Zoledronic Acid Hospira.
Danish: - hvis du er overfølsom (allergisk) over for zoledronsyre, et andet bisfosfonat (den gruppe af stoffer,
English: One ml solution contains 0.04 mg zoledronic acid (as monohydrate).
Danish: En ml opløsning indeholder 0,04 mg zoledronsyre (som monohydrat).
English: Renal impairment has been observed following the administration of zoledronic acid (see section 4.8), especially in patients with pre-existing renal dysfunction or other risks including advanced age, concomitant nephrotoxic medicinal products, concomitant diuretic therapy (see section 4.5), or dehydration occurring after zoledronic acid administration.
Danish: 4.8), specielt hos patienter med eksisterende nedsat nyrefunktion eller andre risici såsom fremskreden alder, samtidig anvendelse af nefrotoksiske lægemidler, samtidig dialysebehandling (se pkt.
English: Other medicines and Zoledronic Acid Hospira
Danish: Tilberedelse og indgift af Zoledronsyre Hospira
English: What Zoledronic Acid Hospira is and what it is used for What you need to know before you are given Zoledronic Acid Hospira How Zoledronic Acid Hospira is used Possible side effects
Danish: Det skal du vide om Zoledronsyre Hospira Sådan bliver du behandlet med Zoledronsyre Hospira Bivirkninger
English: − Keep Zoledronic Acid Hospira out of the reach and sight of children.
Danish: - Opbevar Zoledronsyre Hospira utilgængeligt for børn.