natgillin/translations-raw huggingface dataset:
Andre lægemidler, der indeholder zoledronsyre som aktiv substans er tilgængelige til osteoporose indikationer og til behandling af Pagets sygdom i knoglerne. 
Other products containing zoledronic acid as active substance are available for osteoporosis indications and treatment of Paget´s disease of the bone.
Hos patienter med nedsat nyrefunktion kan den systemiske virkning af samtidigt indgivne lægemidler, der primært udskilles via nyrerne, øges. 
In patients with renal impairment, the systemic exposure to concomitant medicinal products that are primarily excreted via the kidney may increase.
Zoledronsyre anbefales ikke til patienter, der før behandlingen initieres, har svær nyreinsufficiens, som i denne population er defineret som CLcr <30 ml/min. 
Zoledronic acid is not recommended for patients presenting with severe renal impairment prior to initiation of therapy, which is defined for this population as CLcr < 30 ml/min.
Typen af bivirkninger, der blev observeret i denne befolkningsgruppe, var sammenlignelig med tidligere observerede bivirkninger hos voksne med fremskreden malign sygdom, der involverer knoglerne (se pkt. 
The type of adverse reactions observed in this population were similar to those previously seen in adults with advanced malignancies involving the bone (see section 4.8).
Forebyggelse af skeletrelaterede hændelser (patologiske frakturer, spinal kompression, strålebehandlingeller operation af knogler, eller tumorinduceret hyperkalcæmi) hos voksne patienter med fremskredenmalign sygdom og knoglemetastaser. 
- Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.
Meget sjælden (kan forekomme hos op til 1 ud af 10.000 patienter) Sig det til lægen, hvis du får øresmerter, udflåd fra øret og/eller betændelse i øret. 
Very Rare (may affect up to 1 in 10,000 people) Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.
I enkelt-dosis infusions hundestudier, administreret over 15 minutter, var 1,0 mg/kg (6 gange den anbefalede humane terapeutiske eksponering baseret på AUC) fint tolereret uden nyreproblemer. 
In the single-dose dog infusion studies, 1.0 mg/kg (6 fold the recommended human therapeutic exposure based on AUC) administered over 15 minutes was well tolerated with no renal effects.
POSE ETIKET 
VIAL LABEL
Interstitiel lungesygdom (inflammation af vævet omkring luftsækkende i lungerne). 
Interstitial lung disease (inflammation of the tissue around the air sacks of the lungs)
Hypokalcæmi er blevet rapporteret hos patienter i behandling med zoledronsyre. 
Hypocalcaemia has been reported in patients treated with zoledronic acid.
Dystoki blev observeret ved den laveste dosis (0,01 mg/kg kropsvægt), der blev afprøvet i rotter. 
Dystocia was observed at the lowest dose (0.01 mg/kg body weight) tested in rats.
Zoledronsyre metaboliseres ikke systemisk og påvirker ikke de humane cytokrom P450 enzymer in vitro (se pkt. 
Zoledronic acid is not systemically metabolised and does not affect human cytochrome P450 enzymes in vitro (see section 5.2).
Følgende risikofaktorer bør overvejes ved evaluering af en patients risiko for at udvikle ONJ: - Styrken af bisfosfonat (højere risiko for højpotente forbindelser), administrationsvej (højere risiko for parenteral administration) og kumulative doser af bisfosfonater. 
The following risk factors should be considered when evaluating an individual's risk of developing ONJ: - Potency of the bisphosphonate (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bisphosphonate.
Den leveres i 100 ml plastikpose som en infusionsvæske klar til brug. 
It comes in 100 ml plastic bags as a readyto-use solution for infusion.
- Zoledronsyre Hospira må kun gives af sundhedspersonale, som er trænet til at indgive bisfosfonater intravenøst, dvs. gennem en blodåre (også kaldt IV administration). 
− Zoledronic Acid Hospira must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein (also referred to as ‘IV' administration).
- Lavt indhold af magnesium og kalium i blodet. 
− Low level of magnesium and potassium in the blood.
Det vil hjælpe dig med at undgå væsketab. 
This will help to prevent dehydration.
Lægen, sygeplejersken og apoteket ved, hvordan Zoledronsyre Hospira skal opbevares korrekt (se pkt. 
Your doctor, nurse or pharmacist knows how to store Zoledronic Acid Hospira properly (see section
I en pooled analyse af sikkerhedsdata fra zoldronsyre-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 trials for the use of zoledronic acid 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%).
- 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.
Zoledronsyre har været forbundet med rapporter om nedsat nyrefunktion. 
Zoledronic acid has been associated with reports of renal dysfunction.
Tabel 6: Bivirkninger observeret hos pædiatriske patienter med svær osteogenesis imperfecta Nervesystemet 
Table 6: Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta Nervous system disorders
- Zoledronsyre Hospira 4 mg/100 ml infusionsvæske, opløsning kan anvendes straks uden yderligere tilberedning til patienter med normal nyrefunktion. 
- Zoledronic Acid Hospira 4 mg/100 ml solution for infusion can be used immediately without further preparation for patients with normal renal function.
Det er vigtigt, at du drikker mindst 2 glas væske (fx vand), inden for et par timer før behandling med Zoledronsyre Hospira, som anvist af sundhedspersonalet. 
It is important for you to drink at least 2 glasses of fluid (such as water), within a few hours before receiving Zoledronic Acid Hospira, as directed by your healthcare provider.
Brug af anden medicin og Zoledronsyre Hospira Fortæl det altid til lægen, apotekspersonalet eller til din sygeplejerske, hvis du bruger anden medicin eller har brugt det for nylig. 
Other medicines and Zoledronic Acid Hospira Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Nedsat nyrefunktion er set efter administration af zoledronsyre, specielt hos patienter med eksisterende nyreproblemer eller yderligere risikofaktorer (f.eks. ældre patienter, cancerpatienter i kemoterapibehandling, samtidig behandling med nefrotoksiske lægemidler, samtidig behandling med diuretika, svær dehydrering), hvoraf de fleste modtog en dosis på 4 mg hver 3.-4. uge, men det er set hos patienter efter en enkelt administration. 
Renal impairment has been observed following the administration of zoledronic acid, especially in patients with pre-existing renal dysfunction or additional risk factors (e.g. advanced age, oncology patients with chemotherapy, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, severe dehydration), the majority of whom received a 4 mg dose every 3-4 weeks, but it has been observed in patients after a single administration.
For alvorlige bivirkninger af atrieflimren var den samlede incidens 1,3% for zoledronsyre og 0,8% for placebo. 
For atrial fibrillation serious adverse events the pooled incidences were 1.3% for zoledronic acid and 0.8% for placebo.
- 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.
Opløsningen indeholdende zoledronsyre må ikke fortyndes yderligere eller blandes med andre infusionsopløsninger. 
− The solution containing zoledronic acid must not be further diluted or mixed with other infusion solutions.
Behandling med zoledronsyre til TIH-patienter, som også har svær nyreinsufficiens, bør kun overvejes efter vurdering af risici og fordele ved behandlingen. 
Zoledronic acid treatment in TIH patients who also have severe renal impairment should be considered only after evaluating the risks and benefits of treatment.
Zoledronsyre Hospira kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger. 
Like all medicines, Zoledronic Acid Hospira can cause side effects, although not everybody gets them.
Risikoen for at få disse bivirkninger aftager ved de efterfølgende doser Zoledronsyre Hospira. 
The chance of experiencing these side effects decreases with subsequent doses of Zoledronic Acid Hospira.
Ud fra et mikrobiologisk synspunkt skal produktet anvendes straks. 
From a microbiological point of view, the product should be used immediately.
- hvis du har fået fjernet en eller flere af biskjoldbruskkirtlerne på halsen ved en operation. 
- if you have had some or all of the parathyroid glands in your neck surgically removed.
Lægen vil tage blodprøver, inden du begynder behandling med Zoledronsyre Hospira, og vil med regelmæssige mellemrum kontrollere, hvordan du reagerer på behandlingen. 
Your doctor will carry out blood tests before you start treatment with Zoledronic Acid Hospira and will check your response to treatment at regular intervals.
Præ-eksisterende hypokalcæmi skal behandles med tilstrækkelig indgivelse af calcium og Dvitamin, før behandling med zoledronsyre initieres (se pkt. 
Pre-existing hypocalcaemia must be treated by adequate intake of calcium and vitamin D before initiating therapy with zoledronic acid (see section 4.3).
Zoledronsyre Hospira må ikke blandes eller gives intravenøst sammen med andre lægemidler. 
Zoledronic Acid Hospira must not be mixed or given intravenously with any other medicinal products.
Zoledronsyre Hospira må ikke komme i kontakt med calciumholdige opløsninger. 
Zoledronic Acid Hospira must not be allowed to come into contact with any calcium-containing solutions.
Faktorer, der kan øge potentialet for nedsættelse af nyrefunktionen, inkluderer dehydrering, allerede eksisterende nyreinsufficiens, adskillige cyklus af zoledronsyre og andre bisfosfonater så vel som brug af andre nefrotoksiske lægemidler. 
Factors that may increase the potential for deterioration in renal function include dehydration, pre-existing renal impairment, multiple cycles of zoledronic acid and other bisphosphonates as well as use of other nephrotoxic medicinal products.
Dosisjustering er ikke nødvendig til patienter med kreatinin clearance ≥ 35 ml/min. 
No dose adjustment is necessary in patients with creatinine clearance 35 ml/min.
Nyreproblemer (fx nedsat mængde urin) kan forekomme. 
Kidney disorders (e.g. decreased urine output) may occur.
Instruktion i fremstilling af reducerede doser Zoledronsyre Hospira 
Instructions for preparing reduced doses of Zoledronic Acid Hospira
Zoledronsyre inhiberer ikke humane P450-enzymer in vitro og udviser ingen biotransformation, og i dyreforsøg blev <3 % af den indgivne dosis fundet i fæces, hvilket antyder, at leverfunktionen ikke spiller en væsentlig rolle for zoledronsyres farmakokinetiske egenskaber. 
Zoledronic acid does not inhibit human P450 enzymes in vitro, shows no biotransformation and in animal studies < 3% of the administered dose was recovered in the faeces, suggesting no relevant role of liver function in the pharmacokinetics of zoledronic acid.
Skævheden som blev observeret i studiet er ikke observeret i andre studier med zoledronsyre, ej heller i studier med zoledronsyre 4 mg hver 3-4 uge i onkologiske patienter. 
The imbalance observed in this trial has not been observed in other trials with zoledronic acid, including those with zoledronic acid 4 mg every 3-4 weeks in oncology patients.
Udtag mængden af Zoledronsyre Hospira, som angivet på posen, før administration. 
Remove the volume of Zoledronic Acid Hospira solution indicated from the bag prior to administration.
Behandlingens start eller en ny behandling bør udskydes hos patienter med uhelede sår i det bløde væv i munden. 
The start of treatment or of a new course of treatment should be delayed in patients with unhealed open soft tissue lesions in the mouth.
Et tandeftersyn med forebyggende tandbehandling og en individuel benefit/risk-vurdering anbefales inden behandling med Zoledronsyre Hospira hos patienter med samtidige risikofaktorer. 
A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with Zoledronic Acid Hospira in patients with concomitant risk factors.
6 ml, type I, klart hætteglas eller 5 ml plastik hætteglas, med en fluorpolymer-belagt halobutyl prop og med aluminiumsforsegling og flip-off låg. 
6 ml, type I clear glass vial or 5 ml plastic vial, stoppered with a fluoropolymer-coated halo-butyl closure and sealed with an aluminium seal and flip-off top.
Patienter skal være passende hydreret før administration af Zoledronsyre Hospira. 
Patients must be appropriately hydrated prior to administration of Zoledronic Acid Hospira.
Behandlingens start eller en ny behandling bør udskydes hos patienter med uhelede sår i det bløde væv i munden, undtaget i akutte medicinske tilfælde. 
The start of treatment or of a new course of treatment should be delayed in patients with unhealed open soft tissue lesions in the mouth, except in medical emergency situations.
Populationsanalyser viste, at for en patient med en kreatinin clearance på 20 ml/min (svær nyreinsufficiens) eller på 50 ml/min (moderat insufficiens), skulle den tilsvarende beregnede clearance af zoledronsyre være henholdsvis 37% eller 72% af clearance hos en patient med en kreatinin clearance på 84 ml/min. 
Population analysis showed that for a patient with creatinine clearance of 20 ml/min (severe renal impairment), or 50 ml/min (moderate impairment), the corresponding predicted clearance of zoledronic acid would be 37% or 72%, respectively, of that of a patient showing creatinine clearance of 84 ml/min.
Nogle havde tilbagevendende symptomer ved gentagen behandling med zoledronsyre eller med andre bisfosfonater. 
A subset had recurrence of symptoms when rechallenged with zoledronic acid or another bisphosphonate.
Under behandling bør invasiv tandbehandling udføres med forsigtighed og undgås tæt på zoledronsyrebehandling. 
While on treatment, invasive dental procedures should be performed with caution and avoided in close proximity to zoledronic acid treatment.
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.
- 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.
Da der ikke foreligger data om foreneligheden af Zoledronsyre Hospira med andre intravenøst indgivne stoffer, må Zoledronsyre Hospira ikke blandes med andre lægemidler/stoffer og bør altid gives igennem en separat infusionsslange. 
− Since no data are available on the compatibility of Zoledronic Acid Hospira with other intravenously administered substances, Zoledronic Acid Hospira must not be mixed with other medicinal products/substances and should always be given through a separate infusion line.
Din læge vil fortælle dig om de symptomer, som forbindes med hypokalcæmi (for lavt indhold af calcium i blodet). 
Your doctor will inform you regarding the symptoms associated with hypocalcaemia.
Enkeltinfusioner og gentagne infusioner over 5 og 15 minutter af 2, 4, 8 og 16 mg zoledronsyre til 64 patienter gav nedenstående farmakokinetiske data, som viste sig at være uafhængige af dosis. 
Single and multiple 5 and 15-minute infusions of 2, 4, 8 and 16 mg zoledronic acid in 64 patients yielded the following pharmacokinetic data, which were found to be dose independent.
Faktorer, der kan øge risikoen for nedsat nyrefunktion, inkluderer dehydrering, allerede eksisterende nyreinsufficiens, flere behandlingscyklusser af zoledronsyre eller andre bisfosfonater så vel som brug af andre nefrotoksiske lægemidler eller brug af en kortere infusionstid end anbefalet på nuværende tidspunkt. 
Factors that may increase the potential for deterioration in renal function include dehydration, pre-existing renal impairment, multiple cycles of zoledronic acid or other bisphosphonates, as well as concomitant use of nephrotoxic medicinal products or using a shorter infusion time than currently recommended.
Det er en inhibitor af osteoklastisk medieret knogleresorption. 
It is an inhibitor of osteoclast-mediated bone resorption.
Det bruges til: - At forebygge knoglekomplikationer, f.eks. knoglebrud, hos voksne patienter med knoglemetastaser (spredning af kræft fra den primære kræftknude til knoglerne). 
It is used: To prevent bone complications, e.g. fractures, in adult patients with bone metastases (spread of cancer from primary site to the bone).
Du bør ikke få Zoledronsyre Hospira, hvis du er gravid. 
You should not be given Zoledronic Acid Hospira if you are pregnant.
Hver pakning indeholder 1 pose som indeholder 4 mg zoledronsyre. 
Each pack contains one bag which contains 4 mg of zoledronic acid.
Serumcalcium bør måles og hypokalcæmi korrigeres, inden zoledronsyre-behandling påbegyndes. 
Serum calcium should be measured and hypocalcaemia must be corrected before initiating zoledronic acid therapy.
De følgende bivirkninger, opført i tabel 2, er samlet fra kliniske forsøg og post-marketing rapporter efter fortrinsvis kronisk behandling med 4 mg zoledronsyre: 
The following adverse reactions, listed in Table 2, have been accumulated from clinical studies and post-marketing reports following predominantly chronic treatment with 4 mg zoledronic acid:
Patiener, der behandles med Zoledronsyre Hospira bør ikke behandles med disse produkter eller andre bisfosfanat produkter samtidigt, da den kombinerede virkning af disse stoffer er ukendte. 
Patients being treated with Zoledronic Acid Hospira should not be treated with such products or any other bisphosphonate concomitantly, since the combined effects of these agents are unknown.
Alle patienter bør opfordres til at opretholde en god mundhygiejne, gennemgå rutinemæssige tandeftersyn og straks rapportere eventuelle orale symptomer såsom tandmobilitet, smerter eller hævelse, vedvarende sår eller sekretion under behandling med zoledronsyre. 
All patients should be encouraged to maintain good oral hygiene, undergo routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling, non-healing of sores or discharge during treatment with zoledronic acid.
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlæggeresultaterne af studier med referencelægemidlet indeholdende zoledronsyre i alle undergrupper af den pædiatriske population for Pagets knoglesygdom (se pkt. 
The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing zoledronic acid in all subsets of the paediatric population in Paget's disease of the bone (see section 4.2 for information on paediatric use).
Efter påbegyndelse af infusion med zoledronsyre, øges plasmakoncentrationen af den aktive substans hurtigt, og maksimal koncentration nås ved slutningen af infusionsperioden, efterfulgt af et hurtigt fald til < 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. 
After initiation of the zoledronic acid infusion, plasma concentrations of the active substance increased rapidly, 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 levels.
De følgende bivirkninger, opført i tabel 1, er samlet fra kliniske forsøg og post-marketing rapporter efter fortrinsvis kronisk behandling med 4 mg zoledronsyre: 
The following adverse reactions, listed in Table 1, have been accumulated from clinical studies and post-marketing reports following predominantly chronic treatment with 4 mg zoledronic acid:
Patienter skal holdes velhydrerede før og efter administration af Zoledronsyre Hospira. 
Patients must be maintained well hydrated prior to and following administration of Zoledronic Acid Hospira.
Ikke kendt** Dehydrering sekundært til symptomer som feber, opkastning og diarré efter behandlingen. 
Dehydration secondary to post-dose symptoms such as fever, vomiting and diarrhoea
- Når du skal tilberede en infusionsvæske indeholdende 4 mg zoledronsyre, skal du opløse Zoledronsyre Hospira koncentratet (5,0 ml) yderligere med 100 ml calciumfri eller anden infusionsvæske uden indhold af divalente kationer. 
− To prepare an infusion solution containing 4 mg zoledronic acid, further dilute the Zoledronic Acid Hospira concentrate (5.0 ml) with 100 ml of calcium-free or other divalent cation-free infusion solution.
Alle patienter bør opfordres til at opretholde en god mundhygiejne, gennemgå rutinemæssige tandeftersyn og straks rapportere eventuelle orale symptomer såsom tandmobilitet, smerter eller hævelse eller vedvarende sår eller sekretion under behandling med zoledronsyre. 
All patients should be encouraged to maintain good oral hygiene, undergo routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling, or non-healing of sores or discharge during treatment with zoledronic acid.
Dette lægemiddel må ikke komme i kontakt med calcium-holdige opløsninger. 
This medicinal product must not be allowed to come into contact with any calcium-containing solutions.
tandkødslidelser, eller en planlagt tandudtrækning; - du ikke får regelmæssig tandpleje eller ikke har haft et tandeftersyn i lang tid; - du ryger (det kan øge risikoen for tandproblemer); - du tidligere er blevet behandlet med bisfosfonat (bruges til at behandle eller forebygge knoglekomplikationer); - du tager medicin kaldet kortikosteroider (fx prednisolon eller dexamethason); - du har kræft. 
Before receiving Zoledronic Acid Hospira, tell your doctor, pharmacist or nurse if - you have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction; - you do not receive routine dental care or have not had a dental check-up for a long time; - you are a smoker (as this may increase the risk of dental problems); - you have previously been treated with a bisphosphonate (used to treat or prevent bone disorders); - you are taking medicines called corticosteroids (such as prednisolone or dexamethasone) - you have cancer.
- Sløret syn, tåreflåd, lysfølsomhed i øjnene. 
− Blurred vision, tearing of the eye, eye sensitivity to light.