natgillin/translations-raw huggingface dataset:
Atorvastatin sænkede signifikant totalcholesterol, LDL-cholesterol, triglycerider og apolipoprotein B i de første 26 uger (dobbeltblindede fase).
Atorvastatin significantly decreased plasma levels of total-C, LDL-C, triglycerides, and apolipoprotein B during the 26 week double-blind phase.
I et 8-ugers, open-label klinisk forsøg blev børn i alderen 6-17 år og i Tanner-stadie 1 (n=15) eller Tanner-stadie ≥ 2 (n=24) med heterozygot familiær hyperkolesterolæmi og baseline LDL-C ≥ 4 mmol/l behandlet med hhv. 5 mg eller 10 mg tyggetabletter eller 10 mg eller 20 mg filmovertrukne tabletter 1 gang dagligt.
In an openlabel, 8-week study, Tanner Stage 1 (N=15) and Tanner Stage ≥2 (N=24) paediatric patients (ages 6-17 years) with heterozygous familial hypercholesterolemia and baseline LDL-C ≥4 mmol/L were treated with 5 or 10 mg of chewable or 10 or 20 mg of film-coated atorvastatin tablets once daily, respectively.
4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen
4.4 Special warnings and precautions for use {As currently approved}.
6.4 Særlige opbevaringsforhold [Udfyldes nationalt]
6.4 Special precautions for storage {As currently approved}.
4.6 Fertilitet, graviditet og amning
4.6 Pregnancy and lactation {As currently approved}.
Atorvastatin sænkede signifikant total-cholesterol, LDL-cholesterol, triglycerider og apolipoprotein B i de første 26 uger (dobbelt-blindede fase).
LDL-C, triglycerides, and apolipoprotein B during the 26 week double-blind phase.
Tilsvarende hermed sås fald i LDL-cholesterol og total-cholesterol i forhold til atorvastatin- og ohydroxyatorvastatin-niveauer.
Consistent decreases in LDL-C and TC were observed over the range of atorvastatin and o-hydroxyatorvastatin exposures.
6.6 Regler for destruktion <og anden håndtering> [Udfyldes nationalt]
6.6 Special precautions for disposal {As currently approved}.
4.3 Kontraindikationer
4.3 Contraindications {As currently approved}.
6.5 Emballagetype og pakningsstørrelser <og specielt udstyr til anvendelse, administration eller implantation> [Udfyldes nationalt]
6.5 Nature and contents of container {As currently approved}.
Indehaveren af markedsføringstilladelsen og fremstiller [Udfyldes nationalt]
Marketing Authorisation Holder and Manufacturer {Name and address} <{tel}> <{fax}> <{e-mail}> [See Annex I - To be completed nationally]
Særlige patientgrupper: -[Udfyldes nationalt] - Børn: Der findes ikke farmakokinetiske data hos børn.
− Paediatric: Pharmacokinetic data in the paediatric population are not available.
DET SKAL DE VIDE, FØR DE BEGYNDER AT TAGE ZARATOR [Udfyldes nationalt]
BEFORE YOU TAKE {PRODUCT NAME} {As currently approved}.
DATO FOR ÆNDRING AF TEKSTEN <MM/ÅÅÅÅ> <[Udfyldes nationalt]>
{PRODUCT NAME} 80 mg film-coated tablets Atorvastatin calcium [See Annex I - To be completed nationally]
-1 Levende, ikke-patogene Escherichia coli O8:K87: 1,3∙108 til 9,0∙108 CFU/dosis
1.3∙108 to 9.0∙108 CFU*/dose.
* kolonidannende enheder
* colony forming units
EU-nummer (Markedsføringstilladelse)
EU (MA) Number Invented name
Dato for seneste fornyelse: 28 april 2017.
Date of latest renewal: 28 April 2017.
Responsraten hos disse patienter var cirka 52 %.
The response rate in these patients was about 52%.
Reduktion i risiko for multiple hændelser**
Risk reduction of suffering from multiple events**
NA Ikke relevant (Not Applicable)
NA Not applicable
Mediantid til normokalcæmi var 4 dage.
Median time to normocalcaemia was 4 days.
Der sås i særdeleshed ikke noget klart bevis for virkning på forekomsten af fraktur eller på smerte.
In particular there was no clear evidence of efficacy on incidence of fracture or on pain.
Al ubrugt opløsning bør bortskaffes.
Any unused solution should be discarded.
Indlægssedlen er tilsvarende opdateret.
The package leaflet is updated accordingly.
Den bidragende rolle af zoledronsyre behandling kunne i disse tilfælde ikke udelukkes.
The contributive role of zoledronic acid therapy in these cases could not be excluded.
Forekomsten af osteonekrose er multifaktoriel og er sammenkædet med forskellige risikofaktorer.
The occurrence of osteonecrosis is multifactorial and is associated with various risk factors.
- at nedsætte mængden af calcium i blodet hos voksne patienter, hvor det er for højt som følge af tilstedeværelsen af en tumor.
- to reduce the amount of calcium in the blood in adult patients where it is too high due to the presence of a tumour.
• Den totale tidsperiode mellem fortynding, opbevaring i køleskab og afslutning af administration må ikke overskride 96 timer.
• The total time between dilution, storage in the refrigerator and end of administration must not exceed 96 hours.
Baseline kreatininclearance (ml/min)
Baseline creatinine clearance (ml/min)
Opløsningen skal have tid til at nå til 20 °C - 23,5 °C før administration.
The solution must be allowed to reach 20°C to 23.5°C before administration.
Dato for første markedsføringstilladelse: 03 august 2012.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 03 August 2012.
Da der kun eksisterer begrænsede kliniske data for patienter med svært nedsat leverfunktion, kan der ikke gives nogen specifikke anbefalinger for denne patientgruppe.
As only limited clinical data are available in patients with severe hepatic insufficiency, no specific recommendations can be given for this patient population.
Behandlingens virkning var mindre udtalt hos patienter med blastiske læsioner.
The treatment effects were less pronounced in patients with blastic lesions.
Disse transverse eller korte skrå frakturer kan forekomme hvor som helst på femur, fra lige under trochanter minor til lige over det suprakondylære svaj.
These transverse or short oblique fractures can occur anywhere along the femur from just below the lesser trochanter to just above the supracondylar flare.
- En nyresygdom, der hedder Fanconis syndrom (vil normalt blive fastslået af din læge med nogle bestemte urinprøver).
- A kidney function disorder called Fanconi syndrome (will normally be determined by your doctor with certain urine tests).
Fortæl lægen, hvis du er gravid eller har mistanke om, at du er det.
Tell your doctor if you are or think that you may be pregnant.
Alder, vægt, køn og kreatininclearance synes ikke at have nogen virkning på systemisk eksponering over for zoledronsyre.
Age, body weight, gender and creatinine clearance appear to have no effect on zoledronic acid systemic exposure.
Der er ingen tilstrækkelige data fra anvendelse af zoledronsyre til gravide kvinder.
There are no adequate data on the use of zoledronic acid in pregnant women.
Mange af disse patienter fik også kemoterapi og kortikosteroider og viste tegn på lokal infektion inklusive osteomyelitis.
Many of these patients were also receiving chemotherapy and corticosteroids and had signs of local infection including osteomyelitis.
Pamidronat 90 mg
Pamidronate 90 mg
• Bisfosfonatets potens (øget risiko ved højpotente stoffer), administrationsvej (øget risiko ved parenteral administration) og kumuleret dosis af bisfosfonat.
• Potency of the bisphosphonate (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bisphosphonate.
• Den totale tidsperiode mellem fortynding, opbevaring i køleskab og afslutning af administration må ikke overskride 24 timer.
• The total time between dilution, storage in the refrigerator and end of administration must not exceed 24 hours.
Zoledronsyre medac kan gives til patienter i alderen 65 år og derover.
Zoledronic acid medac can be given to people aged 65 years and over.
De estimerede behandlingsvirkninger på BMD var ens, men studiedesignet var ikke robust nok til at etablere en non-inferiør virkning for zoledronsyre.
Estimated treatment effects on BMD were similar, but the trial design was not sufficiently robust to establish non-inferior efficacy for zoledronic acid.
Selvom der ikke blev observeret teratogenicitet eller føtal toksicitet hos kaniner, blev der observeret maternal toksicitet.
Although no teratogenicity or foetotoxicity was observed in the rabbit, maternal toxicity was found.
CLcr beregnes ud fra serum-kreatinin ved brug af Cockeroft-Gault-formlen.
CLcr is calculated from serum creatinine using the Cockcroft-Gault formula.
- Alvorlige allergiske reaktioner: åndenød, hævelse hovedsageligt i ansigt og hals.
- Severe allergic reaction: shortness of breath, swelling mainly of the face and throat.
- hvis du er allergisk over for zoledronsyre, et andet bisfosfonat (den gruppe af stoffer, som
- if you are allergic to zoledronic acid, another bisphosphonate (the group of substances to which
I løbet af de første 24 timer genfindes 39±16 % af den administrerede 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.
Der har været meget sjældne tilfælde af døsighed og søvnighed ved brug af zoledronsyre.
There have been very rare cases of drowsiness and sleepiness with the use of zoledronic acid.
Hvis hypokalcæmi, hypofosfatæmi eller hypomagnesæmi forekommer, kan supplerende behandling være nødvendigt i kort tid.
If hypocalcaemia, hypophosphataemia, or hypomagnesaemia occurs, short-term supplemental therapy may be necessary.
Hvis du har fået for meget Zoledronsyre medac 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 medac than you should be If you have received doses higher than those recommended, you must be carefully monitored by your doctor.
Forekomsten af SRE (hændelser/person-år) var 0,628 for zoledronsyre og 1,096 for placebo.
The SRE rate (events/person year) was 0.628 for zoledronic acid and 1.096 for placebo.
Disse resultater forhindrede bestemmelsen af zoledronsyres definitive virkning på fertiliteten hos mennesker.
Thus these results precluded determining a definitive effect of zoledronic acid on fertility in humans.
Efter fortynding af koncentratet skal den fremstillede opløsning være klar, farveløs og uden synlige partikler.
After dilution of the concentrate the prepared solution should be clear, colourless and free of visible particles.
Mens du er i behandling med Zoledronsyre medac, skal du opretholde god mundhygiejne (herunder regelmæssig tandbørstning) og få rutinemæssige tandeftersyn.
While being treated with Zoledronic acid medac, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Dystoci blev observeret ved den laveste dosis (0,01 mg/kg kropsvægt), der blev testet hos rotter.
Dystocia was observed at the lowest dose (0.01 mg/kg bodyweight) tested in the rat.
Disse frakturer forekommer efter minimalt eller intet traume, og nogle patienter får lår- eller lyskesmerter, ofte med tilhørende scanningskarakteristika af stressfrakturer, uger til måneder før den komplette femurfraktur viser sig.
These fractures occur after minimal or no trauma and some patients experience thigh or groin pain, often associated with imaging features of stress fractures, weeks to months before presenting with a completed femoral fracture.
Mutagenicitet og karcinogenicitet
Mutagenicity and carcinogenic potential
Interindividuel variabilitet med hensyn til farmakokinetiske parametre for zoledronsyre var høj, som det er set med andre bisfosfonater.
The interpatient variability in pharmacokinetic parameters for zoledronic acid was high, as seen with other bisphosphonates.
Alle patienter bør opfordres til at opretholde god oral hygiejne, få rutinemæssige tandeftersyn og straks rapportere alle orale symptomer, såsom tandmobilitet, smerter eller hævelse, eller ikke helende sår eller udsivning i løbet af behandlingen med Zoledronsyre medac.
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 medac.
Hvis der kræves en nedsat dosis af Zoledronsyre medac, skal der først udtages en passende volumen som angivet nedenfor og derefter fortynde yderligere med 100 ml infusionsopløsning.
If a lower dose of Zoledronic acid medac is required, first withdraw the appropriate volume as indicated below and then dilute it further with 100 ml of infusion solution.
Andre lægemidler, der indeholder zoledronsyre som aktivt stof, er tilgængelige for osteoporoseindikationer og behandling af Pagets knoglesygdom.
Other medicinal products containing zoledronic acid as active substances are available for osteoporosis indications and treatment of Paget´s disease of the bone.
Et tandeftersyn med passende forebyggende tandbehandling og en individuel benefit-risk-vurdering anbefales før behandling med bisfosfonater hos patienter med flere samtidige risikofaktorer.
A dental examination with appropriate preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with bisphosphonates in patients with concomitant risk factors.
Behandlingsplanen for patienter, der udvikler ONJ, bør udfærdiges i tæt samarbejde mellem den behandlende læge og en tandlæge eller en kæbekirurg med erfaring i ONJ.
The management plan for patients who develop ONJ should be set up in close collaboration between the treating physician and a dentist or oral surgeon with expertise in ONJ.
CHMP anbefaler, at betingelserne for markedsføringstilladelsen ændres.
The CHMP recommends that the terms of the marketing authorisation(s) should be varied.
For patienter med behov for tandoperationer er der ikke nogen tilgængelige data, der viser, om seponering af behandlingen med bisfosfonater reducerer risikoen for osteonekrose af kæberne.
For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw.
Starttidspunktet er ≤3 dage efter infusion med zoledronsyre, og reaktionen er også refereret til ved brug af termerne ”influenza-lignende symptomer” eller ”symptomer efter dosering”.
The onset time is ≤ 3 days post-zoledronic acid infusion, and the reaction is also referred to using the terms “flu-like” or “post-dose” symptoms.
Smertescoringen for zoledronsyre var konsekvent under baseline og smertereduktionen var ledsaget af en tendens til nedsat smertestillende score.
The pain score for zoledronic acid was consistently below baseline and pain reduction was accompanied by a trend in reduced analgesics score.
Zoledronsyres sikkerhed og virkning hos børn i alderen 1-17 år er ikke klarlagt.
The safety and efficacy of zoledronic acid in children aged 1 year to 17 years have not been established.
Mediantiden for fremkomst af den første SRE blev ikke nået i den zoledronsyrebehandlede studiearm ved slutningen af studiet og var signifikant forlænget sammenlignet med placebo (p=0,007).
Median time to onset of the first SRE was not reached in the zoledronic acid-treated arm at the end of the study and was significantly prolonged compared to placebo (p=0.007).
Behandlingsperioden i studiet var 12 måneder forudgået af en 4-9-ugers screeningsperiode, hvor der blev givet tilskud af calcium og D-vitamin i mindst 2 uger.
The study treatment period was 12 months preceded by a 4- to 9-week screening period during which vitamin D and elemental calcium supplements were taken for at least 2 weeks.
Der findes ingen sted-specifikke risiko faktorer for osteonekrose ud over øgede orale risiko faktorer for osteonekrose af kæben.
There are no site specific risk factors for osteonecrosis apart from additional oral risk factors for osteonecrosis of the jaw.
Patienter bør få deres serum-kreatinin-niveau vurderet før hver dosis af zoledronsyre.
Patients should have their serum creatinine levels assessed prior to each dose of zoledronic acid.
Begrænsede farmakokinetiske data hos børn med svær osteogenesis imperfecta indikerer, at zoledronsyres farmakokinetik hos børn i alderen 3-17 år er sammenlignelig med voksnes ved samme mg/kg dosisniveau.
Limited pharmacokinetic data in children with severe osteogenesis imperfecta suggest that zoledronic acid pharmacokinetics in children aged 3 to 17 years are similar to those in adults at a similar mg/kg dose level.
Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for zoledronsyre (indiceret til cancer og frakturer) er CHMP nået frem til følgende videnskabelige konklusioner:
Taking into account the PRAC Assessment Report on the PSUR(s) for zoledronic acid (indicated for cancer and fractures), the scientific conclusions of CHMP are as follows:
Pamidronat 90 mg (N = 99) 33,3 % * p-værdier sammenlignet med pamidronat.
Pamidronate 90 mg (N=99) *p-values compared to pamidronate.
Hvor meget Zoledronsyre medac skal du have - Den normale enkeltdosis er 4 mg. - Hvis du har problemer med nyrerne, vil lægen give dig en lavere dosis afhængigt af sværhedsgraden af dine nyreproblemer.
How much Zoledronic acid medac 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.
Der bør udvises forsigtighed, når zoledronsyre anvendes sammen med andre potentielt nefrotoksiske lægemidler.
Caution is indicated when zoledronic acid is used with other potentially nephrotoxic medicinal products.
Der blev udført et forlænget studie for at vurdere den generelle og renale langtidssikkerhed af zoledronsyre administreret en eller to gange årligt over en forlænget behandlingsperiode af 12 måneders varighed hos børn, der havde gennemført et års behandling med enten zoledronsyre eller pamidronat i hovedstudiet.
An extension study was conducted in order to examine the long-term general and renal safety of once yearly or twice yearly zoledronic acid over the 12-month extension treatment period in children who had completed one year of treatment with either zoledronic acid or pamidronate in the core study.
Under behandling bør der kun udføres invasiv tandbehandling efter en nøje overvejelse, og de bør undgås tæt på administrationen af zoledronsyre.
While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to zoledronic acid administration.
- Søvnighed.
- Sleepiness.
Den nedsatte dosis til patienter med nedsat nyrefunktion forventes at give samme AUC, som er set hos patienter med kreatininclearence 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.
Almindelig (kan forekomme hos op til 1 ud af 10 personer): - Svært nedsat nyrefunktion (vil normalt blive afgjort af din læge ved hjælp af en speciel type blodprøver).
Common (may affect up to 1 in 10 people): - Severe kidney impairment (will normally be determined by your doctor with certain specific blood tests).
Undersøgelsens primære endepunkt var den procentuelle ændring i knoglemineralsk densitet (BMD) i lænderygsøjlen efter 12 måneders behandling.
The primary endpoint of the study was the percent change from baseline in lumbar spine bone mineral density (BMD) after 12 months of treatment.
Der optrådte hurtigere normalisering af korrigeret serum-calcium på 4. dag for 8 mg zoledronsyre og på 7. dag for 4 mg og 8 mg zoledronsyre.
There was faster normalisation of corrected serum calcium at day 4 for 8 mg zoledronic acid and at day 7 for 4 mg and 8 mg zoledronic acid.
Rapporterne om osteonekrose af andre steder med zoledronsyre antyder lighed i forekomsten af hyppighed (femur>knæ>humerus) sammenlignet med de mest almindeligt påvirkede steder af osteonekrose baseret på anatomiske faktorer.
The reports of osteonecrosis at other sites with zoledronic acid suggest similarity in reporting frequency (femur>knee>humerus) as compared to the commonly affected sites of osteonecrosis based on anatomical factors.
På baggrund af de videnskabelige konklusioner for zoledronsyre (indiceret til cancer og frakturer) er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel, der indeholder zoledronsyre (indiceret til cancer og frakturer), forbliver uændret i forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
On the basis of the scientific conclusions for zoledronic acid (indicated for cancer and fractures) the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing zoledronic acid (indicated for cancer and fractures) is unchanged subject to the proposed changes to the product information
* Omfatter vertebrale og non-vertebrale frakturer ** Indeholder alle skeletrelaterede hændelser, det totale antal samt tid til hver hændelse under studiet.
* Includes vertebral and non-vertebral fractures ** Accounts for all skeletal events, the total number as well as time to each event during the trial NR Not reached
Behandlingsstart eller start på et nyt behandlingsforløb bør udskydes hos patienter med ikke helede åbne bløddelslæsioner i munden, undtagen i medicinske nødsituationer.
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.
Instruktion for tilberedning af reducerede doser af zoledronsyre
Instructions for preparing reduced doses of zoledronic acid
I den zoledronsyrebehandlede gruppe blev statistisk signifikante forbedringer i smerte-scoringer (ved brug af Brief Pain Inventory, BPI) set ved 4 uger og ved hver efterfølgende tidsmåling i løbet af studiet, sammenlignet med placebo (Figur 1).
In the zoledronic acid-treated group, statistically significant improvement in pain scores (using the Brief Pain Inventory, BPI) was seen at 4 weeks and at every subsequent time point during the study, when compared to placebo (Figure 1).
- Hvis du er i behandling for at nedsætte calciumindholdet i blodet, vil du som regel kun få én infusion med Zoledronsyre medac.
- 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 medac.
Zoledronsyre var ikke mutagen i de udførte mutagenicitetsprøver, og undersøgelse af karcinogenicitet kunne ikke påvise karcinogenicitet.
Zoledronic acid was not mutagenic in the mutagenicity tests performed and carcinogenicity testing did not provide any evidence of carcinogenic potential.
Idet disse patienter kun blev efterbehandlet med en dosis på 8 mg, er der ingen tilgængelige data som gør det muligt at sammenligne med en dosis på 4 mg zoledronsyre.
Since those patients were retreated with the 8 mg dose only, there are no data available allowing comparison with the 4 mg zoledronic acid dose.
BILAG IV VIDENSKABELIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF BETINGELSERNE FOR MARKEDSFØRINGSTILLADELSEN/-ERNE
ANNEX IV SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S)
Resultater fra kliniske studier af behandlingen for svær osteogenesis imperfecta hos pædiatriske patienter i alderen 1-17 år
Clinical trial results in the treatment of severe osteogenesis imperfecta in paediatric patients aged 1 to 17 years
Ved analyse af de individuelle sikkerhedsrapporter fra kliniske forsøg, spontane rapporter og litteratur, blev der genfundet 62 tilfælde af osteonekrose i forbindelse med zoledronsyre af andre anatomiske steder, hvoraf hovedparten af disse tilfælde forekom i hoften/femur (46).
The analysis of the individual safety reports from clinical trials, spontaneous reports and literature retrieved 62 cases of osteonecrosis of other anatomical sites in association with zoledronic acid, with the majority of events occurring in the hip/femur (46).
EXP: Læs indlægssedlen for opbevaringstiden for lægemidlet efter første anbrud.
EXP: Read the leaflet for the shelf life of the medicinal product after first opening.
Der eksisterer ingen farmakokinetiske data for zoledronsyre hos patienter med hyperkalcæmi eller patienter med nedsat leverfunktion.
No pharmacokinetic data for zoledronic acid are available in patients with hypercalcaemia or in patients with hepatic insufficiency.