natgillin/translations-raw huggingface dataset:
- hvis du er gravid.
- if you are pregnant.
** Baseret på post-marketing rapporter.
** Based on post-marketing reports.
Frekvens kan ikke estimeres ud fra forhåndenværende data.
Frequency cannot be estimated from available data.
Nogle bivirkninger kan være alvorlige
Some side effects could be serious
Stabil i 24 timer ved 2
Stable for 24 hours at 2
Teratogenstudier blev udført på to arter, begge via subkutan administration.
Teratology studies were performed in two species, both via subcutaneous administration.
Infusionen skal gennemføres i henhold til medicinsk standardpraksis.
The infusion must be conducted according to standard medical practice.
Udtag en passende volumen af koncentratet efter følgende:
Withdraw an appropriate volume of the concentrate needed, as follows:
Vær derfor særlig opmærksom når du kører bil, betjener maskiner eller udfører andre opgaver, der kræver din fulde opmærksomhed.
You should therefore be careful when driving, using machines or performing other tasks that need full attention.
NR Ikke nået (Not Reached)
NR Not Reached
Hver pakning indeholder en pose.
Each pack contains one bag.
Dato for første markedsføringstilladelse: 19. november 2012 Dato for seneste fornyelse: 24. august 2017
Date of first authorisation: 19 November 2012 Date of latest renewal: 24 August 2017
Fem af de 6 patienter havde SAP inden for normalområdet ved måned 6 (Last Observation Carried Forward, LOCF).
Five of the 6 patients had SAP within the normal range at month 6 (Late Observation Carried Forward, LOCF).
KVALITATIV OG KVANTITATIV SAMMENSÆTNING
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Efter åbning: 24 timer ved 2 °C - 8 °C
After opening: 24 hours at 2°C - 8°C
Voksne og ældre
Adults and elderly
Ikke kendt** Hypotension (nogle af patienterne havde underliggende risikofaktorer)
Hypotension (some of the patients had underlying risk factors)
Hvis sygdommen ikke behandles, kan knoglerne blive deforme og smertefulde, og de kan brække.
If the disease is not treated, bones may become deformed and painful, and may break.
Lægen bør overveje klinisk monitorering for disse patienter.
Physicians should consider clinical monitoring for these patients.
Det er vigtigt, at du følger dette råd nøje, så mængden af calcium i blodet ikke bliver for lav i perioden efter infusionen.
It is important that you follow this advice carefully so that the level of calcium in your blood does not become too low in the period after the infusion.
For at mindske risikoen for udvikling af osteonekrose i kæben, er der nogle forholdsregler, du bør tage.
In order to reduce the risk of developing osteonecrosis of the jaw, there are some precautions you should take.
Frekvensen af hypokalcæmi var meget lavere efter de efterfølgende infusioner.
The frequency of hypocalcaemia was much lower following subsequent infusions.
Den kliniske relevans af resultaterne er ikke kendt.
The clinical relevance of these findings is unknown.
Dosisjustering er ikke nødvendig, da biotilgængelighed, fordeling og elimination var ens hos ældre patienter og yngre forsøgspersoner.
No dose adjustment is necessary since bioavailability, distribution and elimination were similar in elderly patients and younger subjects.
Lokale reaktioner
Local reactions
- hvis du har alvorlige nyreproblemer.
- if you have severe kidney problems.
Hvis du bruger tandproteser, skal du sikre dig, at de passer dig ordentligt.
If you wear dentures you should make sure these fit properly.
Følgende oplysninger er tiltænkt læger og sundhedspersonale:
The following information is intended for medical or health care professionals only.
* Inkluderer vertebrale og non-vertebrale frakturer
* Includes vertebral and non-vertebral fractures
I løbet af de første 24 timer findes 39 ± 16% af den indgivne dosis i urinen, hvorimod den resterende mængde primært er bundet til knoglevævet.
Over the first 24 hours, 39 ± 16% of the administered dose is recovered in the urine, while the remainder is principally bound to bone tissue.
Hvis du oplever nogen af ovenstående bivirkninger, skal du straks kontakte din læge.
If you experience any of the above side effects, you should contact your doctor immediately.
Der sås ingen symptomatiske tilfælde af hypokalcæmi.
No symptomatic cases of hypocalcaemia were observed.
Uåbnet pose: 2 år.
Unopened bag: 2 years.
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
• Monitoring af serumkreatinin bør overvejes hos risikopatienter.
• Monitoring of serum creatinine should be considered in at-risk patients.
* Kun almindelig ved Pagets sygdom.
* Common in Paget's disease only.
Din læge kan anbefale mild smertestillende medicin som ibuprofen eller paracetamol for at mindske disse bivirkninger.
Your doctor can recommend a mild pain reliever such as ibuprofen or paracetamol to reduce these side effects.
Alder, vægt, køn og kreatinin clearance synes ikke at have nogen effekt på systemisk eksponering af zoledronsyre.
Age, body weight, gender and creatinine clearance appear to have no effect on zoledronic acid systemic exposure.
Undersøgelser Meget almindelig:
Investigations Very common:
Patienterne bør informeres om symptomer på hypokalcæmi og få passende klinisk monitorering i risikoperioden.
Patients should be informed about symptoms of hypocalcaemia and receive adequate clinical monitoring during the period of risk.
- hvis du ikke kan tage dagligt calcium tilskud.
- if you are unable to take daily calcium supplements.
Zoledronsyre Hospira kan virke i mere end et år, og din læge vil fortælle dig, om du skal behandles igen.
Zoledronic Acid Hospira may work for longer than one year, and your doctor will let you know if you need to be treated again.
Figur 1: Gennemsnitlige ændringer fra baseline i BPI scoringer.
Figure 1: Mean changes from baseline in BPI scores.
Der er ikke udført interaktionsundersøgelser med andre lægemidler.
No interaction studies with other medicinal products have been performed.
Patienter, som blev klassificeret som respondere efter 6 måneders hovedstudie, var egnet til at deltage i et udvidet opfølgningsstudie.
Patients who were classified as responders at the end of the 6 month core study were eligible to enter an extended follow-up period.
Efter åbning: 24 timer ved 2
After opening: 24 hours at 2
- Lavt blodtryk.
− Low blood pressure.
Det er vigtigt at prøve at undgå udvikling af osteonekrose i kæben, da det er en smertefuld lidelse, som kan være svær at behandle.
It is important to try and prevent ONJ developing as it a painful condition that can be difficult to treat.
- Forvirring.
− Confusion.
Zoledronsyre Hospira kan gives til patienter i alderen 65 år og derover.
Zoledronic Acid Hospira can be given to people aged 65 years and over.
- hvis du har fået fjernet dele af tarmen.
- if you have had sections of your intestine removed.
Som for andre bisfosfonater er retentionsstiden af zoledronsyre i knogler meget lang.
As with other bisphosphonates, the retention time of zoledronic acid in bones is very long.
Inter- og intraindividuel variation i zoledronsyreclearance i plasma er vist at være henholdsvis 36% og 34%.
The inter- and intra-subject variation for plasma clearance of zoledronic acid was shown to be 36% and 34%, respectively.
De tidlige dispositionsfaser (α og β med ovenstående t½-værdier) repræsenterer formodentlig hurtigt optag i knogle og udskillelse via nyrerne.
The early disposition phases (α and β, with t½ values above) presumably represent rapid uptake into bone and excretion via the kidneys.
Uåbnet pose: 2 år
Unopened bag: 2 years
Behandlingaf TIH
Treatment of TIH
Zoledronsyre Hospira kan også give andre bivirkninger Meget almindelige (kan forekomme hos flere end 1 ud af 10 patienter) Feber
Zoledronic Acid Hospira may also cause other side effects Very common (may affect more than 1 in 10 people) Fever
Bivirkningerne i tabel 1 er anført i henhold til MedDRA organklassificering og frekvens.
Adverse reactions in Table 1 are listed according to MedDRA system organ class and frequency category.
- hvis du har eller har haft nyreproblemer.
− if you have or have had a kidney problem.
Symptomerne er almindeligvis milde til moderate og forsvinder inden for tre dage.
The symptoms are usually mild to moderate and go away within three days.
Dette er specielt vigtigt for patienter, der tager diuretika (”vandrivende”) og for ældre patienter.
This is especially important in patients who take diuretics (“water pills”) and in elderly patients.
Patienter, som har fået højere doser end de anbefalede, bør derfor overvåges nøje.
Patients who have received doses higher than those recommended should be carefully monitored.
Hvis hypokalcæmi, hypofosfatæmi eller hypomagnesiæmi forekommer, kan supplement behandling være nødvendigt i kort tid.
If hypocalcaemia, hypophosphataemia, or hypomagnesaemia occurs, short-term supplemental therapy may be necessary.
Denne optagelse i knoglevævet er fælles for alle bisfosfonater og er formentlig en konsekvens af den strukturelle lighed med pyrofosfat.
This uptake into bone is common for all bisphosphonates and is presumably a consequence of the structural analogy to pyrophosphate.
** Indeholder alle skeletrelaterede hændelser, det totale antal samt tid til hver hændelse under undersøgelsen
** Accounts for all skeletal events, the total number as well as time to each event during the trial
Hvis du har glemt en dosis Zoledronsyre Hospira Kontakt din læge eller dit hospital så hurtigt som muligt for at få en ny tid.
If you missed a dose of Zoledronic Acid Hospira Contact your doctor or hospital as soon as possible to re-schedule your appointment.
Skeletal morbiditets rate p-værdi
Skeletal morbidity rate p-value
• En enkelt dosis zoledronsyre bør ikke overstige 5 mg, og infusionsvarigheden bør være mindst 15 minutter (se pkt.
• A single dose of zoledronic acid should not exceed 5 mg and the duration of infusion should be at least 15 minutes (see section 4.2).
Der blev ikke observeret teratogene eller embryo/føtal effekter hos kaniner, selvom maternal toksicitet blev bemærket ved 0,1 mg/kg på grund af nedsat niveau af serum calcium.
No teratological or embryo/foetal effects were observed in rabbits, although maternal toxicity was marked at 0.1 mg/kg due to decreased serum calcium levels.
Selvom risikoen reduceres ved administration af en dosis zoledronsyre over 15 minutter, kan der stadig opstå forværring af nyrefunktionen.
While the risk is reduced with a dose of zoledronic acid administered over 15 minutes, deterioration in renal function may still occur.
Det er normalt, at gammelt knoglevæv nedbrydes og erstattes med nyt knoglevæv.
It is normal that old bone is removed and is replaced with new bone material.
Det er meget almindeligt, at der ses bivirkninger efter den første infusion (ses hos flere end 30 % af patienterne), mens det er mindre almindeligt efter de efterfølgende infusioner.
Side effects related to the first infusion are very common (occurring in more than 30% of patients) but are less common following subsequent infusions.
(vises i en cirkel)
(to appear in roundel)
Følgende forholdsregler bør tages for at minimere risikoen for nyrerelaterede bivirkninger:
The following precautions should be taken into account to minimise the risk of renal adverse reactions:
• Forbigående øgning i serumkreatinin kan være højere hos patienter med underliggende nyresygdom.
• Transient increase in serum creatinine may be greater in patients with underlying impaired renal function.
Spørg din læge, apotekspersonalet eller sygeplejersken til råds, før du tager dette lægemiddel.
Ask your doctor, pharmacist or nurse for advice before taking this medicine.
Ved Pagets sygdom er knogleremodelleringen for hurtig, og nyt knoglevæv dannes på en sygelig måde, som gør det svagere end normalt.
In Paget's disease, bone remodelling is too rapid and new bone is formed in a disordered fashion, which makes it weaker than normal.
I forsøgene med Pagets sygdom sås der symptomatisk hypokalcæmi hos ca. 1% af patienterne, og det forsvandt hos alle.
In the Paget's disease trials, symptomatic hypocalcaemia was observed in approximately 1% of patients, in all of whom it resolved.
Incidensen af post-dosis-symptomer , der opstår inden for de første tre dage efter administration af Zoledronsyre Hospira, kan reduceres ved at administrere paracetamol eller ibuprofen kort efter administration af Zoledronsyre Hospira.
The incidence of post-dose symptoms occurring within the first three days after administration of Zoledronic Acid Hospira can be reduced with the administration of paracetamol or ibuprofen shortly following Zoledronic Acid Hospira administration.
- En nyrelidelse kaldet Fanconi syndrom (vil normalt blive afgjort af din læge ved hjælp af en speciel type urinprøve).
A kidney function disorder called Fanconi syndrome (will normally be determined by your doctor with certain urine tests).
- Lavt antal røde blodceller (anæmi).
− Low level of red blood cells (anaemia).
Fremstiller Hospira UK Limited Horizon
Manufacturer Hospira UK Limited Horizon
Derfor forhindrede disse resultater bestemmelse af zoledronsyres definitive effekt på fertilitet i mennesker.
Thus these results precluded determining a definitive effect of zoledronic acid on fertility in humans.
Følgende er de vigtigste identificerede risici med zoledronsyre for de godkendte indikationer:
The following are the important identified risks with zoledronic acid in the approved indications:
Infusionen vil vare mindst 15 minutter.
The infusion will take at least 15 minutes.
Patienterne var lige fordelt mellem den zoledronsyrebehandlede og placebo grupperne.
Patients were evenly distributed between zoledronic acid -treated and placebo groups.
Der foreligger ikke tilstrækkelige data om brugen af zoledronsyre hos gravide kvinder.
There are no adequate data on the use of zoledronic acid in pregnant women.
Hvis der kræves en nedsat dosis af Zoledronsyre Hospira, skal der først udtages en passende mindre volumen som angivet nedenfor og derefter fortyndes yderligere med 100 ml infusionsopløsning.
If a lower dose of Zoledronic Acid Hospira is required, first withdraw the appropriate volume as indicated below and then dilute it further with 100 ml of infusion solution.
Den overordnede procentdel af patienter, som oplevede bivirkninger, var henholdsvis 44,7%, 16,7% og 10,2% efter første, anden og tredje infusion.
The overall percentage of patients who experienced adverse reactions were 44.7%, 16.7% and 10.2% after the first, second and third infusion, respectively.
Andre forstyrrelser af mineralmetabolismen skal ligeledes behandles effektivt (f.eks. hypoparathyroidisme, intestinal calciummalabsorption).
Other disturbances of mineral metabolism must also be effectively treated (e.g. diminished parathyroid reserve, intestinal calcium malabsorption).
Størstedelen af disse bivirkninger opstår inden for de første tre dage efter administration af zoledronsyre.
The majority of these reactions occur within the first three days following zoledronic acid administration.
Zoledronsyre bør kun genoptages, når serum-kreatinin igen er inden for 10% af baseline.
Zoledronic acid should only be resumed when serum creatinine returns to within 10% of baseline.
Bivirkninger med frekvenser <5% blev vurderet medicinsk, og det blev vist, at de er i overensstemmelse med den veletablerede sikkerhedsprofil for zoledronsyre (se pkt.
Adverse events occurring with frequencies < 5% were medically assessed and it was shown that these cases are consistent with the well established safety profile of zoledronic acid (see section 4.8)
Disse resultater var i overensstemmelse med målinger af biokemiske markører, som viste normal knogleomsætning.
These results were consistent with biochemical marker evidence of normalisation of bone turnover.
Der har været meget sjældne tilfælde af døsighed og søvnighed ved brug af Zoledronsyre Hospira.
There have been very rare cases of drowsiness and sleepiness with the use of Zoledronic Acid Hospira.
Hvor meget Zoledronsyre Hospira skal du have - Den normale enkeltdosis er 4 mg. - Hvis du har problemer med nyrerne, vil lægen give dig en lavere dosis afhængig af sværhedsgraden af dine nyreproblemer.
How much Zoledronic Acid Hospira is given - The usual single dose given is 4 mg. - If you have a kidney problem, your doctor will give you a lower dose depending on the severity of your kidney problem.
- Lavt antal hvide blodceller og blodplader.
− Low counts of white blood cells and blood platelets.
1 intravenøs pose
1 intravenous bag
Det tilhører en gruppe af stoffer, kaldet bisfosfonater, og anvendes til behandling af Pagets sygdom i knoglerne hos voksne.
It belongs to a group of medicines called bisphosphonates and is used to treat Paget's disease of the bone in adults.
- Hvis du er i behandling for at nedsætte calciumindholdet i blodet, vil du som regel kun få én infusion med Zoledronsyre Hospira.
- If you are being treated to reduce the amount of calcium in your blood, you will normally only be given one infusion of Zoledronic Acid Hospira.
Hypokalcæmi er en vigtig, identificeret risiko ved zoledronsyre ved de godkendte indikationer.
Hypocalcaemia is an important identified risk with zoledronic acid in the approved indications.
- Lavt niveau af calcium i blodet.
− Low level of calcium in the blood.
Måling af serum calcium inden infusion med zoledronsyre er anbefalet hos patienter med Pagets sygdom.
Measurement of serum calcium before infusion of zoledronic acid is recommended for patients with Paget´s disease.
Procentdelen af patienter, som oplevede bivirkninger, var lavere i et mindre studie (19,5%, 10,4%, 10,7% efter henholdsvis den første, anden og tredje infusion), hvor profylakse mod bivirkninger blev anvendt.
The percentage of patients who experienced adverse reactions was lower in a smaller study (19.5%, 10.4%, 10.7% after the first, second and third infusion, respectively), where prophylaxis against adverse reactions was used.
Størstedelen af bivirkningerne, såsom feber og kulderystelser, smerter i muskler eller led og hovedpine, opstår inden for de første tre dage efter en dosis Zoledronsyre Hospira.
The majority of the side effects, such as fever and chills, pain in the muscles or joints, and headache, occur within the first three days following the dose of Zoledronic Acid Hospira.
Der er hos nogle patienter også set stigninger i serum-kreatinin ved kronisk administration af zoledronsyre i anbefalede doser til forebyggelse af skeletrelaterede hændelser, selvom dette er mindre hyppigt.
Increases in serum creatinine also occur in some patients with chronic administration of zoledronic acid at recommended doses for prevention of skeletal related events, although less frequently.
Hvis du har fået for meget Zoledronsyre Hospira Hvis du har fået højere doser end dem, der er anbefalet, skal du nøje overvåges af din læge.
If you are given more Zoledronic Acid Hospira than you should be If you have received doses higher than those recommended, you must be carefully monitored by your doctor.
Hos patienter med multipelt myelom kan risikoen for nedsat nyrefunktion øges, når zoledronsyre anvendes i kombination med thalidomid.
In multiple myeloma patients, the risk of renal dysfunction may be increased when zoledronic acid is used in combination with thalidomide.
Din læge kan råde dig til at tage et tilskud af calcium og D-vitamin (f.eks. tabletter) i mindst de første ti dage, efter du har fået Zoledronsyre Hospira.
Your doctor may advise you to take calcium and vitamin D supplements (e.g. tablets) for at least the first ten days after being given Zoledronic Acid Hospira.
• Patienter, specielt ældre patienter og patienter i behandling med diuretika, bør være passende hydreret forud for behandling med zoledronsyre.
• Patients, especially elderly patients and those receiving diuretic therapy, should be appropriately hydrated prior to administration of zoledronic acid.
Du må ikke få Zoledronsyre Hospira, hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid.
You must not be given Zoledronic Acid Hospira if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.
Zoledronsyre bør ikke anvendes under graviditet.
Zoledronic acid should not be used during pregnancy.
Ud over at være en potent hæmmer af knogleresorption, har zoledronsyre også adskillige anti-tumor egenskaber der kan bidrage til den samlede effekt i behandling af metastaserende knoglesygdom.
In addition to being a potent inhibitor of bone resorption, zoledronic acid also possesses several antitumour properties that could contribute to its overall efficacy in the treatment of metastatic bone disease.
Den anbefalede dosis er en enkelt intravenøs infusion af 5 mg zoledronsyre.
The recommended dose is a single intravenous infusion of 5 mg zoledronic acid.
Der var ingen akkumulering af den aktive substans i plasma efter gentagne doser administreret hver 28. dag.
There was no accumulation of the active substance in plasma after multiple doses given every 28 days.
Knoglehistologi blev evalueret hos 7 patienter med Pagets sygdom 6 måneder efter behandling med 5 mg zoledronsyre.
Bone histology was evaluated in 7 patients with Paget's disease 6 months after treatment with 5 mg zoledronic acid.
Læger og sundhedspersonale anmodes om at indberette alle mistænkte bivirkninger via det nationale rapporteringssystem anført i Appendiks V .
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Standard hyperkalcæmirelaterede metaboliske parametre som serumniveauer af calcium, fosfat og magnesium, bør monitoreres grundigt efter påbegyndt behandling med zoledronsyre.
Standard hypercalcaemia-related metabolic parameters, such as serum levels of calcium, phosphate and magnesium, should be carefully monitored after initiating zoledronic acid therapy.
Instruktion for tilberedning af reducerede doser af Zoledronsyre Hospira: Udtag det passende volumen af det flydende koncentrat efter følgende: - 4,4 ml til 3,5 mg dosis
Instructions for preparing reduced doses of Zoledronic Acid Hospira: Withdraw the appropriate volume of the liquid concentrate, as follows: - 4.4 ml for 3.5 mg dose
Følgende egenskaber er vist i prækliniske undersøgelser:
The following properties have been demonstrated in preclinical studies:
I et større klinisk studie blev der rapporteret lokale reaktioner som rødme, hævelse og/eller smerter på infusionsstedet (0,7%) efter administration af zoledronsyre.
In a large clinical trial, local reactions at the infusion site, such as redness, swelling and/or pain, were reported (0.7%) following the administration of zoledronic acid.
(N=99) *p-værdier sammenlignet med pamidronat.
Pamidronate 90 mg (N=99) *p-values compared to pamidronate.
Efter 6 måneder viste zoledronsyre respons hos 96% (169/176) og en serum alkalisk fosfatase (SAP) normaliseringsrate hos 89% (156/176) sammenlignet med 74% (127/171) og 58% (99/171) for risedronat (alle p < 0,001).
After 6 months, zoledronic acid showed 96% (169/176) and 89% (156/176) response and serum alkaline phosphatase (SAP) normalisation rates compared to 74% (127/171) and 58% (99/171) for risedronate (all p<0.001).
Den nedsatte dosis til patienter med nyreinsufficiens forventes at give samme AUC, som er set hos patienter med kreatinin clearance på 75 ml/min.
The reduced doses for patients with renal impairment are expected to achieve the same AUC as that seen in patients with creatinine clearance of 75 ml/min.
Fejlagtig indgivelse af doser op til 48 mg af zoledronsyre er blevet rapporteret.
The administration of doses up to 48 mg of zoledronic acid in error has been reported.
Efterbehandling af Pagets sygdom: Efter den første behandling med zoledronsyre ved Pagets sygdom er der observeret en længerevarende periode med remission hos responderende patienter.
Re-treatment of Paget's disease: After initial treatment with zoledronic acid in Paget's disease, an extended remission period is observed in responding patients.