natgillin/translations-raw huggingface dataset:
Efter rekonstituering indeholder opløsningen 5 mg alglucosidase alfa* per ml og efter fortynding varierer koncentrationen fra 0,5 mg til 4 mg/ml.
After reconstitution, the solution contains 5 mg of alglucosidase alfa* per ml and after dilution, the concentration varies from 0.5 mg to 4 mg/ml.
Kontakt Deres læge, hvis De har sprunget en infusion over.
If you have missed an infusion, please contact your doctor.
Ubehag i brystet Perifert ødem Lokal hævelse Træthed3
Chest discomfort Peripheral oedema Local swelling Fatigue3
Efter rekonstituering indeholder opløsningen 5 mg alglucosidase alfa pr. ml og efter fortynding varierer koncentrationen fra 0,5 mg til 4 mg/ml.
After reconstitution, the solution contains 5 mg of alglucosidase alfa per ml and after dilution the concentration varies from 0.5 mg to 4 mg/ml.
25 hætteglas pulver til koncentrat til infusionsvæske, opløsning.
25 vials powder for concentrate for solution for infusion.
• Rødmen i huden
• Redness of the skin
Det skal De vide, før De begynder at bruge Myozyme Sådan får De Myozyme
What Myozyme is and what it is used for What you need to know before you are given Myozyme How Myozyme is given
Sent debuterende Pompes sygdom2
Late-onset Pompe disease
Hjerte meget almindelig
Cardiac disorders very common
Fortæl det straks til Deres læge, hvis De oplever en sådan reaktion.
Should you experience any reaction like this, please tell your doctor immediately.
Opkastning Kvalme3
Nausea3
• Bleghed
• Tiredness
10 hætteglas pulver til koncentrat til infusionsvæske, opløsning.
10 vials powder for concentrate for solution for infusion.
Fornyet indgivelse af Myozyme til patienter, der har oplevet infusionsrelaterede reaktioner (og især anafylaktiske reaktioner), skal ske med forsigtighed (se pkt.
Patients who have experienced IARs (and in particular anaphylactic reactions) should be treated with caution when re-administering Myozyme (see sections 4.3 and 4.8).
• Muskelspasmer
• Muscle pain
Farmakokinetikken for alglucosidase alfa blev undersøgt i en populationsanalyse på 32 patienter med sent debuterende Pompes sygdom, fra det randomiserede, dobbeltblindede, placebokontrollerede studie.
The pharmacokinetics of alglucosidase alfa were studied in a population analysis of 32 late-onset Pompe disease patients from the randomized, double-blind, placebo-controlled study ranging in age from 21 to 70 years who received Myozyme 20 mg/kg once every two weeks.
Yngre patienter, som blev diagnosticeret og behandlet tidligt og som fik ITI samtidig med at enzymerstatningsterapi blev initieret, viste en tendens til bedre overlevelsesrate end patienter, der blev behandlet med et lignende regime men i en senere alder. Studiedata viste, at profylaktisk ITI forebygger eller reducerer forekomsten af antistoffer mod alglucosidase alfa over tid, hvilket kan opretholde de kliniske fordele ved enzymerstatningsterapi og forbedre overlevelsen hos CRIM-negative IOPD-patienter.
The study data demonstrated that prophylactic ITI prevents or reduces the occurrence of antibodies against alglucosidase alfa over time, which may maintain clinical benefit of ERT and improve survival in CRIM-negative IOPD patients.
1.872,5 µg•t/ml for 20 mg/kg og 40 mg/kg dosis.
The mean area under the plasma concentration-time curve (AUC∞) ranged from 977.5 to 1,872.5 µg•h/ml for the 20 mg/kg and 40 mg/kg dose groups.
Livstruende overfølsomhed (anafylaktisk reaktion) over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
Life threatening hypersensitivity (anaphylactic reaction) to the active substance or to any of the excipients listed in section 6.1, when rechallenge was unsuccessful (see sections 4.4 and 4.8).
Sent debuterende Pompes sygdom; pivotalt klinisk studie Sikkerheden og effekten af Myozyme blev undersøgt i et randomiseret, dobbeltblindet, placebokontrolleret studie med 90 patienter med sent debuterende Pompes sygdom i alderen 10-70 år ved start af behandlingen.
The safety and efficacy of Myozyme was assessed in a randomized, double-blind, placebo-controlled study in 90 patients with late-onset Pompe disease who ranged in age from 10 to 70 years at initiation of treatment and were all naive to enzyme replacement therapy.
1 hætteglas pulver til koncentrat til infusionsvæske, opløsning.
1 vial powder for concentrate for solution for infusion.
Hos patienter med debut i spædbørnsalderen, der blev behandlet med en højere dosis (40 mg/kg), blev der observeret en tendens til at udvikle højere titre af IgGantistoffer.
A tendency was observed for infantile-onset patients treated with a higher dose (40 mg/kg)
• Træthed
• Agitation
4.4 og 4.8).
IARs are described in section 4.8.
Hvis De har brugt for meget Myozyme
If you are given more Myozyme than you should
• Hurtigere hjerterytme
• Increased heart rate
En anden open-label undersøgelse vurderede ligeledes sikkerhed og effekt af Myozyme hos 21 patienter med hovedsagelig den atypiske form for Pompes sygdom med debut i spædbørnsalderen, der var fra 6 måneder til 3,5 år ved behandlingens start.
Infantile-onset Pompe disease; clinical trial in patients aged 6 months to 3.5 years A second open-label clinical trial also assessed the safety and efficacy of Myozyme in 21 patients with predominantly a non-typical form of infantile-onset Pompe disease who ranged in age from 6 months to 3.5 years at initiation of treatment.
Knogler, led, muskler og bindevæv almindelig
Musculoskeletal and connective tissue disorders common
• Fortynding
• Vomiting
Sent debuterende Pompes sygdom
Infantile-onset Pompe disease
• Skælven
• Tremor
• Ubehag i brystet
• Chest discomfort
• Indgivelse
Reference
Opkastning almindelig Opkastningsfornemmelser Kvalme
Vomiting common Retching Nausea
Hvert hætteglas indeholder 50 mg alglucosidase alfa Efter rekonstituering indeholder opløsningen 5 mg alglucosidase alfa/ml og efter fortynding varierer koncentrationen fra 0,5 mg til 4 mg/ml.
After reconstitution, the solution contains 5 mg of alglucosidase alfa/ml and after dilution, the concentration varies from 0.5 mg to 4 mg/ml.
Pompes sygdom med debut i spædbørnsalderen samt sent debuterende Pompes sygdom
Infantile- and Lateonset Pompe disease
• Muskelsmerter
• Muscle spasms
Reduceret iltmætning Forhøjet hjertefrekvens
Oxygen saturation decreased
Kvælningsfornemmelser Stridor
Infusion site extravasation
AFSTYLA
Content (concentration)
IU
Pack size
Du må ikke tage Varuby mere end én gang hver anden uge.
Do not take Varuby more than once every two weeks.
Ældre (≥ 65 år)
Elderly people (≥ 65 years)
Dato for første markedsføringstilladelse: 20 April 2017
Date of first authorisation: 20 April 2017
Dette forventes ikke at være klinisk relevant.
This is not expected to be clinically relevant.
De vil give dig en passende behandling.
They will provide appropriate treatment.
Resultaterne blev evalueret for studierne hver for sig og for de to studier sammen.
The results were evaluated for each individual study and for the two studies combined.
• Du kan tage Varuby med eller uden mad.
- You can take Varuby with or without food.
Der er ikke udført dialyseundersøgelser.
Dialysis studies have not been performed.
Konvulsionernes relevans for mennesker er ikke kendt.
The relevance of convulsions for humans is unknown.
Forhold mellem koncentration og effekt
Relationship between concentration and effect
Alder, køn og race/etnicitet
Age, Sex and Race/Ethnicity
Studie 1 og 2 kombineret
Study 1 and 2 Combined
Du kan føle dig svimmel eller træt, når du har taget dette lægemiddel.
You may feel dizzy or tired after taking this medicine.
Hvis det sker, må du ikke køre bil eller betjene værktøj eller maskiner.
If this happens, do not drive or use any tools or machines.
Den laveste virksomme dosis af rosuvastatin skal anvendes.
The lowest effective dose of rosuvastatin is to be used.
a Primært endepunkt var fuldstændigt respons i den sene fase.
N.S. a Primary endpoint was complete response in the delayed phase.
Oral svampeinfektion Candidiasis Oral candidiasis
Oral fungal infection Candidiasis Oral candidiasis
Fuldstændigt respons
Complete Response
Børn og unge under 18 år må ikke tage Varuby, da det ikke er undersøgt til denne gruppe.
Varuby should not be taken by children and adolescents under 18 years because it has not been studied in this group.
Der er ingen oplysninger om virkningerne af denne medicin, hvis den tages under graviditet.
There is no information on the effects of this medicine if taken during pregnancy.
Nye retningslinjer har opdateret disse regimer til højemetogene.
Recent guidance has updated these regimens to highly emetogenic.
Ingen signifikant kvalme (maksimal VAS < 25 på skala 0-100)
No Significant Nausea (maximum VAS <25 on 0-100 scale)
Dag 2 Dag 3 Dag 4
Day 2 Day 3 Day 4
I tilfælde af overdosering skal lægemidlet seponeres og generel understøttende behandling og monitorering iværksættes.
In case of overdose, the medicinal product should be discontinued and general supportive treatment and monitoring should be provided.
Dosisjustering er ikke nødvendig hos ældre.
No dose adjustment is necessary for the elderly.
De hyppigste bivirkninger var træthed (1,9 %) og hovedpine (1,5 %).
The most common adverse reactions were fatigue (1.9%) and headache (1.5%).
Rolapitants sikkerhed og virkning hos børn og unge under 18 år er endnu ikke klarlagt.
The safety and efficacy of rolapitant in children and adolescents below 18 years of age has not yet been established.
Besættelse af NK1-receptorer
NK1 Receptor Occupancy
Det skal du vide, før du begynder at tage Varuby Tag ikke Varuby:
What you need to know before you take Varuby Do not take Varuby:
Tabletterne skal synkes hele sammen med vand og kan tages med eller uden mad.
The tablets should be swallowed whole, with some water and may be taken with or without food.
Derfor kan de potentielle interaktioner forbundet med hæmningen af disse UGT-enzymer i tarmen ikke udelukkes.
Therefore, the potential interactions associated with the inhibition of these UGT enzymes in the intestine cannot be excluded.
Individuelle resultater fra studie 1 og 2 samt et sammendrag af de vigtigste resultater af den kombinerede analyse er vist i tabel 1 nedenfor.
Individual results from Studies 1 and 2 as well as a summary of the key results from the combined analysis are shown in Table 1 below.
Andelen af patienter uden påvirkning af dagligdagen var højere i Varuby-gruppen end i kontrolgruppen (MEC: 73,2 % vs. 67,4 %; p = 0,027).
The proportion of patients with no impact on daily life was higher in the Varuby group than in the control group (MEC: 73.2% vs. 67.4%; p=0.027).
Rolapitant Dette lægemiddel er underlagt supplerende overvågning.
Rolapitant This medicine is subject to additional monitoring.
Varuby gives som en del af et regime, hvori dexamethason og en 5-HT3-antagonist indgår.
Varuby is given as part of a regimen that includes dexamethasone and a 5-HT3 receptor antagonist.
Baseret på miljørisikovurderingen anses rolapitant for at være meget persisterende, bioakkumulerende og ikke hurtigt bionedbrydeligt.
Based on the environmental risk assessment, rolapitant is considered as very persistent, bioaccumulative and not readily biodegradable.
Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter 'Anvendes inden' eller 'EXP'.
Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP'.
Rolapitants absolutte biotilgængelighed er ca. 100 %, hvilket tyder på en minimal first pass-effekt.
The absolute bioavailability of rolapitant is approximately 100%, indicating minimal first pass effect.
Mere end 4.375 patienter er blevet behandlet med Varuby eller en komparator i kliniske fase 1-, 2- og 3-studier.
Over 4,375 patients have been treated with Varuby or a comparator across Phase 1, 2, and 3 clinical studies.
Varuby skal anvendes med forsigtighed til disse patienter.
Varuby should be used with caution in these patients.
Mekanismen bag den signifikante forskel i de observerede halveringstider mellem rotter og aber (6-8 timer) og mennesker (7 dage) er ikke klarlagt.
The mechanism of the significant difference of half-lives observed between the rat and monkey (6-8 h) and human (7 days) is not elucidated.
Du må ikke tage lægemidlet i dagene efter, at du har fået kemoterapi - medmindre du skal til at have en ny kemoterapicyklus.
Do not take this medicine in the days after you have chemotherapy - unless you are about to have another chemotherapy cycle.
Ved dag 6 til 8 efter initiering af kemoterapi blev patienterne bedt om at huske, om de havde haft nogen episoder af opkastning eller opkastningsfornemmelser eller kvalme, som påvirkede deres normale dagligdag.
At Day 6 to 8 following initiation of chemotherapy, patients were asked to recall whether they had any episode of vomiting or retching or nausea that interfered with normal daily life.
Rolapitant var stærkt proteinbundet i humant plasma (99,8 %).
Rolapitant was highly protein bound to human plasma (99.8%).
Hvis kombinationen ikke kan undgås, skal der klinisk og biologisk monitoreres for bivirkninger relateret til det samtidige lægemiddel.
If the combination cannot be avoided, clinical and biological monitoring for adverse reactions related to the concomitant medicinal product must be made.
I et massebalancestudie var metabolitten M19 den væsentligste cirkulerende metabolit.
In a mass balance study, the metabolite M19 was the major circulating metabolite.
Tabletterne er blå og præget med T0101 på den ene side og 100 på den anden.
Tablets are blue, debossed with T0101 on one side and 100 on the other.
OATP1B1- og 1B3-substrater
OATP1B1 and 1B3 substrates
Farmakokinetiske populationsanalyser tyder på, at alder, køn og race ikke har nogen signifikant indvirkning på Varubys farmakokinetik.
Population pharmacokinetic analyses indicated that age, sex and race had no significant impact on the pharmacokinetics of Varuby.
Indeholder også lactose.
Also contains lactose.
Af disse 1.332 patienter fik 629 kemoterapi uden AC.
Of these 1332 patients, 629 received non-AC chemotherapy.
Hvis du har glemt at tage din dosis, skal du fortælle det til lægen med det samme.
If you have forgotten to take your dose, tell your doctor straight away.
30 % af patienterne fik carboplatin i cyklus 1.
The percentage of patients who received carboplatin in Cycle 1 was 30%.
Dyrestudier har ikke påvist teratogene eller embryo-føtale virkninger på fosteret.
Studies in animals have shown no teratogenic or embryo-foetal effects.
Varuby kan påvirke virkningen af andre lægemidler.
Varuby may affect how some other medicines work.
Et sammendrag af resultaterne af MEC-studiet (studie 3) er vist i tabel 2 nedenfor.
A summary of the study results from the MEC Study (Study 3) is shown in Table 2 below.
• Den anbefalede dosis er 180 mg (to 90 mg tabletter).
- The recommended dose is 180 mg (two 90 mg tablets).
Rolapitants antiemetiske aktivitet blev opretholdt under de efterfølgende cyklusserne for de patienter, som fortsatte i hver af de ekstra cyklusser.
Antiemetic activity of rolapitant was maintained throughout repeat cycles for those patients continuing in each of the multiple cycles.
Der har været anvendt rolapitantdoser på op til 720 mg i kliniske studier, uden at det gav anledning til bekymring i forhold til sikkerheden.
Rolapitant doses up to 720 mg have been used in clinical studies without any safety concerns.
• hvis du er allergisk over for rolapitant eller et af de øvrige indholdsstoffer i Varuby (angivet i punkt 6).
- if you are allergic to rolapitant or any of the other ingredients of this medicine (listed in section 6).
Forhøjet INR (International Normalised Ratio) Leukopeni
International Normalised Ratio increased Leukopenia
Rolapitant elimineres langsomt med en gennemsnitlig halveringstid på ca. 7 dage.
Rolapitant is slowly eliminated with a mean terminal half-life of approximately 7 days.
Brevkort med 2 filmovertrukne tabletter - MED BLUE BOX
Wallet card, each containing 2 film-coated tablets - WITH BLUE BOX
Farmakoterapeutisk klassifikation: Antiemetica og midler mod kvalme, andre antiemetica, ATC-kode: A04AD14
Pharmacotherapeutic group: Antiemetics and antinauseants, other antiemetics, ATC code: A04AD14
Forhøjet plasmakoncentration af CYP2D6-substrater kan potentielt medføre bivirkninger.
Increased plasma concentration of CYP2D6 substrates may result in potential adverse reactions.
Der foreligger ingen data vedrørende udskillelse af rolapitant i human mælk.
There are no data on the presence of rolapitant in human milk.
Der er ingen lægemiddelinteraktion mellem rolapitant og dexamethason, og derfor er dosisjustering af dexamethason ikke nødvendig.
There is no medicinal product interaction between rolapitant and dexamethasone, so no dosage adjustment for dexamethasone is required.
Der foreligger ingen data fra anvendelse af rolapitant til gravide kvinder.
There are no available data on rolapitant use in pregnant women.
Det vides ikke, om Varuby udskilles i mælk, og derfor anbefales det ikke at amme under behandling med dette lægemiddel.
It is not known whether Varuby is present in milk; therefore, breast-feeding is not recommended during treatment with this medicine.
Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, genotoksicitet, teratogenicitet samt karcinogenicitet.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity, teratogenic potential, and carcinogenic potential.
Den sædvanlige dosis er to tabletter.
The usual dose is two tablets.
Hver dosis (to tabletter) indeholder 230 mg lactose.
Each dose (two tablets) contains 230 mg of lactose.
Effekter på afkom ved denne dosis var nedsat postnatal overlevelse og nedsat legemsvægt og vægtøgning, og disse kan relateres til den observerede maternelle toksicitet.
Effects on offspring at this dose included decreased postnatal survival, and decreased body weights and body weight gain, and may be related to the maternal toxicity observed.
I puljede prøver indsamlet over 2 uger blev 8,3 % af dosis genfundet i urinen primært som metabolitter, og 37,8 % af dosis blev genfundet i fæces primært som uomdannet rolapitant.
In pooled samples collected over 2 weeks, 8.3% of the dose was recovered in the urine primarily as metabolites and 37.8% of the dose was recovered in the feces primarily as unchanged rolapitant.
I hvilken udstrækning kvalme og opkastning påvirker patienternes dagligdag blev vurderet med Functional Living Index-Emesis (FLIE).
The impact of nausea and vomiting on patients' daily lives was assessed using the Functional Living Index-Emesis (FLIE).
Rolapitant er en selektiv antagonist af human substans P/neurokinin 1 (NK1)-receptorer.
Rolapitant is a selective antagonist of human substance P/neurokinin 1 (NK1) receptors.
Et sammendrag af resultaterne af undergrupperne ikke-AC og AC er vist i tabel 3.
A summary of the results from the non-AC and AC subsets are provided in Table 3.
• Tag tabletterne højst 2 timer, før du starter på din cyklus med kemoterapi.
- Take the tablets within 2 hours before you start your chemotherapy cycle.
Eksponeringsforholdet mellem M19 og rolapitant var ca. 50 % i plasma.
The exposure ratio of M19 to rolapitant was approximately 50% in plasma.
Varuby påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
Varuby has minor influence on the ability to drive and use machines.
Samtidig administration af rifampicin, en potent enzyminduktor, reducerede den systemiske eksponering for rolapitant og dets aktive metabolit signifikant.
Concomitant administration of rifampicin, a strong enzyme inducer significantly decreased the systemic exposure to rolapitant and to its active metabolite.
Svimmelhed og træthed kan forekomme efter administration af rolapitant (se pkt.
Dizziness and fatigue may occur following administration of rolapitant (see section 4.8).
Cisplatinbaseret højemetogen kemoterapi (HEC)
Cisplatin-Based Highly Emetogenic Chemotherapy (HEC)
I alt 1.332 patienter blev inkluderet i evalueringen af effekt, hvoraf 80 % var kvinder, og 20 % var mænd.
A total of 1332 patients were included in the evaluation of efficacy, 80% were women and 20% were men.
UGT1A1- og UGT2B7-substrater (f.eks. hhv. irinotecan og morfin) Rolapitant hæmmede i moderat grad UGT1A1 og UGT2B7 in vitro.
UGT1A1 and UGT2B7 substrates (e.g. irinotecan and morphine, respectively) Rolapitant modestly inhibited UGT1A1 and UGT2B7 in vitro.
Indigokarmin (E 132) Polysorbat 80
Indigo carmine (E132) Polysorbate 80
Et humant positron-emissionstomografi (PET)-studie med rolapitant viste, at rolapitant krydser blodhjerne-barrieren og okkuperer NK1-receptorer i hjernen.
A human Positron Emission Tomography (PET) study with rolapitant demonstrated that rolapitant crosses the blood brain barrier and occupies brain NK1 receptors.
Amning anbefales ikke under behandling med Varuby.
Breast-feeding is not recommended during treatment with Varuby.
Tabletterne skal sluges hele med lidt vand.
Swallow the tablets whole, with some water.
I alt 1.087 patienter blev randomiseret til enten rolapitantregimet (N = 544) eller kontrolbehandling (N = 543) i studie 1 og studie 2; 1.070 patienter blev inkluderet i effektvurderingen; 37 % var kvinder, og 63 % var mænd.
A total of 1087 patients were randomised to either the rolapitant regimen (N=544) or control therapy (N=543) across Study 1 and Study 2; 1070 patients were included in the evaluation of efficacy; 37% were women and 63% were men.
Standarddosis af 5-HT3-antagonist.
Standard dose of 5-HT3 receptor antagonist.
Forlængelsesstudie med flere cyklusser: I hvert studie havde patienterne mulighed for at fortsætte i en forlængelse med op til yderligere 5 kemoterapicyklusser og få den samme behandling som i cyklus 1.
Multiple-Cycle Extension: In each study, patients had the option of continuing into a multiple-cycle extension for up to 5 additional cycles of chemotherapy receiving the same treatment as assigned in cycle 1.
• problemer med at gå
- problems walking
180 mg (to tabletter) administreres højst 2 timer før initiering af hver kemoterapicyklus, men med mindst 2 ugers interval.
180 mg (two tablets) should be administered within 2 hours prior to initiation of each chemotherapy cycle but at no less than 2-week intervals.
2 filmovertrukne tabletter
2 film-coated tablets
Abdominal distension Abdominalsmerter Stomatitis
Abdominal distension Abdominal pain Stomatitis
Dexamethason 20 mg oralt 30 min. inden kemoterapi
Dexamethasone 20 mg orally; 30 min prior to chemotherapy
Hos gnavere blev rolapitant testet i toksicitetsstudier af en varighed på op til 26 uger med gentagne orale doser, og lever, thyreoidea, nyrer, epididymis og uterus blev identificeret som målorganer.
In rodents, rolapitant was tested in repeated dose oral toxicity studies up to 26 weeks in duration, and the liver, thyroid, kidneys, epididymis and uterus were identified as target organs.
Varuby gives som led i kombinationsbehandling (se pkt.
Varuby is given as part of combination therapy (see section 4.2).
Dannelsen af M19 var signifikant forsinket med median-tmax på 120 timer (24-168 timer), og den gennemsnitlige halveringstid for M19 var 158 timer.
The formation of M19 was significantly delayed with the median Tmax of 120 hours (range: 24-168 hours) and the mean half-life of M19 was 158 hours.
Enkeltdosis = 2 tabletter
Single dose = 2 tablets
I alt 1.369 patienter blev randomiseret til enten rolapitantregime (N = 684) eller kontrolbehandling (N = 685).
A total of 1369 patients were randomised to either the rolapitant regimen (N=684) or control therapy (N=685).
Tabletovertræk Polyvinylalkohol Titandioxid (E 171) Macrogol
Polyvinyl alcohol Titanium dioxide (E171) Macrogol
Af disse 1.332 patienter var 28 % over 65 år, og 6 % var over 75 år.
Of these 1332 patients, 28% were greater than 65 years of age and 6% were greater than 75 years of age.
I en farmakokinetisk populationsanalyse af rolapitant var Vd/F 387 l hos cancerpatienter.
In a population pharmacokinetic analysis of rolapitant, the Vd/F was 387 L in cancer patients.
Af de 1.070 patienter var 26 % over 65 år, og 3 % var over 75 år.
Of the 1070 patients, 26% were greater than 65 years of age and 3% were greater than 75 years of age.
HEC studie 1
HEC Study 1