FrancophonIA/ELRC3.0 huggingface dataset:
English: The child's doctor may decide to stop treatment with Sialanar if side effects cannot be managed by reducing the dose.
Danish: Lægen kan beslutte af standse behandlingen med Sialanar, hvis bivirkningerne ikke kan håndteres ved at nedsætte dosis.
English: 3 of 17 patients (17.6%)
Danish: 3 ud af 17 patienter (17,6 %) 0,71 point
English: Oesophageal candidiasis
Danish: Øsofageal candidiasis
English: Pseudo-obstruction
Danish: Pseudo-obstruktion
English: 14 of 19 patients (73.7%)
Danish: 14 ud af 19 patienter (73,7 %) 3,94 point
English: • very hot weather
Danish: • meget varmt vejr
English: Younger children may be more susceptible to adverse events and this should be borne in mind when any dose adjustments are carried out.
Danish: Mindre børn kan være mere følsomme for bivirkninger, og dette skal der tages højde for ved dosisjustering.
English: Patients presenting with anticholinergic toxicity should be transported to the nearest emergency facility with advanced life support capabilities.
Danish: Patienter, der udviser antikolinerg toksicitet, skal transporteres til nærmeste hospital med avanceret genoplivningsudstyr.
English: Gastrointestinal motility disorder
Danish: Gastrointestinale motilitetsforstyrrelser
English: Transient bradycardia
Danish: Forbigående bradykardi
English: If concomitant use cannot be avoided, patients should be monitored for potentially excessive or prolonged CNS depression and constipation;
Danish: Hvis samtidig brug ikke kan undgås, skal patienten overvåges for potentielt kraftig eller langvarig CNS-depression og obstipation.
English: If the event does not resolve treatment should be discontinued.
Danish: Hvis bivirkningen ikke fortager sig, skal behandlingen afbrydes.
English: Primary efficacy endpoint was responder rate, defined as percentage showing ≥3-point improvement on the modified Teacher's Drooling Scale (mTDS).
Danish: Det primære effektmål var responsrate defineret som den procentdel, der udviste en forbedring på ≥ 3 point på mTDS-skalaen (modified Teacher's Drooling Scale).
English: EU/1/16/1135/001 - 250 ml bottle EU/1/16/1135/002 - 60 ml bottle
Danish: EU/1/16/1135/001 - 250 ml flaske EU/1/16/1135/002 - 60 ml flaske
English: Seek medical advice immediately if the child is given too much Sialanar, even if the child seems well.
Danish: Søg straks lægehjælp, hvis barnet/den unge har fået for meget Sialanar, også selvom han/hun ser ud til at have det fint.
English: Gently pull down the plunger to the correct level (see Tables 1 and 2 for the correct dose).
Danish: Træk forsigtigt stemplet nedad til den ønskede målestreg (se tabel 1 og 2 for den korrekte dosis).
English: • opioids used to treat severe pain
Danish: • opioider til behandling af svære smerter
English: Sialanar oral solution is a clear, colourless liquid.
Danish: Sialanar oral opløsning er en klar, farveløs væske.
English: In particular taking Sialanar with the following medicines can affect the way Sialanar or the listed medicine works or can increase the risk of side effects:
Danish: Vær især opmærksom på, at hvis Sialanar tages sammen med følgende lægemidler, kan det påvirke den måde, hvorpå Sialanar og de pågældende lægemidler virker, eller øge risikoen for bivirkninger:
English: Symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders.
Danish: Symptomatisk behandling af svær sialorré (kronisk patologisk spytflåd) hos børn og unge i alderen 3 år og derover med kroniske neurologiske forstyrrelser.
English: • topiramate used to treat epilepsy
Danish: • topiramat til behandling af epilepsi
English: Due to the lack of long term safety data, Sialanar is recommended for short -term intermittent use (see section 4.4)
Danish: På grund af mangel på sikkerhedsdata ved længerevarende brug anbefales det at bruge Sialanar intermitterende i perioder af kortere varighed (se pkt.
English: The primary analysis population was revised to only comprise patients with an age of 3 -16 years which rendered 19 patients in the glycopyrrolate oral solution group an 17 in the placebo group.
Danish: Populationen for den primære analyse blev revideret, så den kun omfattede patienter i alderen 3-16 år, hvilket gav 19 patienter i gruppen, der fik glycopyrrolat i oral opløsning, og 17 patienter i placebogruppen.
English: The physician educational material should contain:
Danish: Informationsmaterialet til lægen skal omfatte:
English: The single dose toxicity of glycopyrronium has been tested in a range of investigations, although only limited experimental details are available.
Danish: Glycopyrroniums toksicitet efter en enkelt dosis er blevet testet i en række undersøgelser, men der foreligger kun begrænsede data.
English: Extrapolation of safety margins to the paediatric population is not possible, as no exposure data are available from repeated dose toxicology studies and no studies in juvenile animals have been performed with glycopyrronium.
Danish: Det er ikke muligt at ekstrapolere sikkerhedsmarginerne til den pædiatriske population, da der ikke foreligger eksponeringsdata fra toksikologistudier med gentagne doser, og da der ikke er gennemført studier af glycopyrronium hos unge dyr.
English: The other ingredients are sodium benzoate (E211), see section 2 (Sialanar contains sodium and benzoate salt), raspberry flavouring (containing propylene glycol E1520), sucralose (E955), citric acid (E330) and purified water.
Danish: Øvrige indholdsstoffer er natriumbenzoat (E211), se punkt 2 (Sialanar indeholder natrium og benzoat), hindbæraroma (indeholder propylenglycol E1520), sucralose (E955), citronsyre (E330) og renset vand.
English: 4 CLINICAL PARTICULARS 4.1 Therapeutic indications
Danish: 4.1 Terapeutiske indikationer
English: Clinical studies have not been conducted in patients with hepatic impairment.
Danish: Der er ikke gennemført kliniske studier hos patienter med nedsat leverfunktion.
English: Sialanar Oral Solution
Danish: Sialanar Oral opløsning
English: Limited non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology or repeated dose toxicity.
Danish: De begrænsede prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi og toksicitet efter gentagne doser.
English: • anticholinergic medicines (see section above “Do not give Sialanar if the child or adolescent:”)
Danish: • antikolinerge lægemidler (se ovenstående punkt "Giv ikke Sialanar til barnet/den unge, hvis han/hun:")
English: At least a 3-point improvement in mTDS
Danish: En forbedring på mindst 3 point på mTDS-skalaen
English: Children with kidney problems may be given a lower dose.
Danish: Børn/unge med nyreproblemer skal eventuelt have en lavere dosis.
English: • antihistamines, used to treat some allergies
Danish: • antihistaminer til behandling af visse typer allergi
English: • The patient information pack should contain: o Patient information leaflet o The reminder card for patient's carer, which shall contain the following key messages:
Danish: Informationsmaterialet til patienten skal omfatte: o Indlægsseddel o Huskekortet til omsorgspersoner, der skal indeholde følgende centrale punkter:
English: After receiving Sialanar, the patient should not drive a vehicle, ride a bicycle or use a machine until the effect in their vision and co-ordination has completely recovered.
Danish: Når barnet/den unge har fået Sialanar, må han/hun ikke køre bil, cykle eller betjene maskiner, før påvirkningen af synet og koordinationsevnen helt har fortaget sig.
English: Analyses of population pharmacokinetic data from healthy adults and children with cerebral palsy-associated chronic moderate to severe drooling who received glycopyrronium (route of administration and dosages not specified) did not demonstrate linear pharmacokinetics of the medicinal product.
Danish: Analyse af populationsfarmakokinetiske data fra raske voksne og børn med cerebral parese og kronisk moderat til svær spytflåd, der fik glycopyrronium (administrationsvej og dosering ikke specificeret), viste ikke en lineær farmakokinetik for lægemidlet.
English: • Management and minimisation of anticholinergic reactions
Danish: • beskrivelse af, hvordan antikolinerge reaktioner håndteres og minimeres
English: Chronic oral administration of glycopyrronium at doses of 4, 16 and 64 mg/kg for up to 27 weeks in dogs produced mydriasis, cycloplegia, xerostomia, emesis, occasional lacrimation, injection of sclera and rhinorrhoea.
Danish: Kronisk oral administration af glycopyrronium i doser på 4, 16 og 64 mg/kg i op til 27 uger hos hunde medførte mydriasis, cykloplegi, xerostomi, opkastning, lejlighedsvist tåreflåd, sclera-injektion og næseflåd.
English: Volume of distribution is somewhat higher in the paediatric population(s), in the range 1.31 to 1.83 L/kg.
Danish: Fordelingsvolumenen var noget højere i de(n) pædiatriske population(er) (interval: 1,31-1,83 l/kg.)
English: • A disorder of the muscles and nerves in the intestine which causes an obstruction or blockage
Danish: • En forstyrrelse i muskler og nerver i tarmsystemet, der kan medføre hæmning eller blokering af tarmbevægelserne
English: The long-term efficacy and safety of Sialanar has not been studied beyond 24 weeks of use.
Danish: Sialanars virkning og sikkerhed ved brug i mere end 24 uger er ikke undersøgt.
English: • Drowsiness (sleepiness)
Danish: • Sløvhed (søvnighed)
English: • antidepressants (tricyclic antidepressants)
Danish: • antidepressiva (såkaldt tricykliske antidepressive midler mod depression)
English: Haematology and chemistry
Danish: Hæmatologi og kemi
English: Thirst in hot weather
Danish: Tørst i varmt vejr
English: There are insufficient data in the public domain to adequately assess effects on the reproductive system in young adults (see section 5.3).
Danish: De offentligt tilgængelige data er ikke tilstrækkelige til at vurdere indvirkningen på det reproduktive system hos unge voksne (se pkt.
English: Modest changes in volume of distribution (Vss) and clearance (Cl) have been observed in children between 1 and 3 years of age, leading to a statistically significant shorter elimination half-life (t½, z) than that observed in younger (<1 year of age; p = 0.037) or older (>3 years of age; p = 0.042) groups.
Danish: Moderate ændringer i fordelingsvolumen (Vss) og clearance (Cl) er observeret hos børn i alderen 1-3 år, hvilket medfører en statistisk signifikant kortere eliminationshalveringstid (t½, z) end hos helt små børn (< 1 år; p = 0,037) og større børn (> 3 år; p = 0,042).
English: The bottle contains 60 ml or 250 ml of oral solution.
Danish: Flasken indeholder 60 ml eller 250 ml oral opløsning.
English: The safety and efficacy of glycopyrronium have been studied in an open labelled study with no control group over a 24-week period in children aged 3 to 18 years.
Danish: Glycopyrroniums sikkerhed og virkning er undersøgt hos børn i alderen 3-18 år i et 24-ugers åbent studie uden kontrolgruppe.
English: Continued use of Sialanar should be discussed with the child's doctor every 3 months to check that Sialanar is still right for the child.
Danish: Fortsat brug af Sialanar skal diskuteres med lægen hver 3. måned, så det kan kontrolleres, om Sialanar stadig er det rigtige for barnet/den unge.
English: Adverse reactions reported in the literature for trials using glycopyrronium for sialorrhoea in the paediatric population (including 2 placebo controlled trials, an uncontrolled safety study using glycopyrronium for a 6 month period, and 3 supportive studies with adverse event data in the target population) are listed by MedDRA system organ class (Table 3).
Danish: Bivirkninger fra faglitteraturen, der er rapporteret i forbindelse med studier af glycopyrronium til behandling af sialorré hos den pædiatriske population (herunder 2 placebokontrollerede studier, et ikke-kontrolleret studie af sikkerheden ved 6 måneders glycopyrronium-behandling og 3 supportive studier med bivirkningsdata fra målpopulationen), er opstillet efter MedDRAs systemorganklasse i tabel 3.
English: Impaired hepatic function is not expected to affect the pharmacokinetics of glycopyrronium since the majority of the medicinal product is eliminated through the kidneys.
Danish: Nedsat leverfunktion forventes ikke at påvirke glycopyrroniums farmakokinetik, da størstedelen af lægemidlet elimineres renalt.
English: • heart disease, heart failure, irregular heartbeats or high blood pressure
Danish: • hjertesygdom, hjertesvigt, uregelmæssig hjerterytme (puls) eller højt blodtryk
English: At the week 24/exit visit, 52.3% (95% confidence interval 43.7-60.9) of patients (n=130) had an at least three-point decrease in mTDS from baseline and were classified as responders to treatment with oral glycopyrrolate solution..
Danish: Ved besøget i uge 24/det afsluttende besøg havde 52,3 % (95 % konfidensinterval 43,7-60,9) af patienterne (n = 130) en forbedring på mindst 3 point på mTDSskalaen i forhold til baseline og blev klassificeret som respondere på behandling med glycopyrrolat i oral opløsning.
English: dose is renally excreted within the first 24 hours.
Danish: Ca. 65 % af en intravenøs dosis udskilles renalt inden for de første 24 timer.
English: They also inhibit the action of acetylcholine where smooth muscle lacks cholinergic innervation.
Danish: De hæmmer også acetylkolins virkning, dér hvor den glatte muskulatur mangler kolinerg innervering.
English: • reduced ability to sweat, which can cause fever and heatstroke.
Danish: • Hæmmet svedafsondring, hvilket kan medføre feber og hedeslag
English: After evaluating the event, the prescriber will decide if treatment should remain stopped or if this should continue at a lower dose.
Danish: Efter vurdering af bivirkningen/forholdet vil den ordinerende læge afgøre, om behandlingen fortsat skal være på pause, eller om den skal genoptages med en lavere dosis.
English: Dose titrations should be conducted in discussion with the carer to assess both efficacy and undesirable effects until an acceptable maintenance dose is achieved.
Danish: Dosis skal titreres i samråd med omsorgspersonen med henblik på vurdering af virkning og bivirkninger, indtil en acceptabel vedligeholdelsesdosis er opnået.
English: In the event of constipation, urinary retention or pneumonia treatment should be stopped and the prescribing physician contacted.
Danish: Ved obstipation, urinretention eller pneumoni skal behandlingen stoppes og den ordinerende læge kontaktes.
English: Decreases >10% from the normal reference range at baseline were observed for carbon dioxide (15.1%), bicarbonate (13.3%), and creatinine (10.7%) concentrations.
Danish: Der er set fald på > 10 % i forhold til det normale baseline-referenceområde hvad angår koncentrationerne af carbondioxid (15,1 %), hydrogencarbonat (13,3 %) og kreatinin (10,7 %).
English: Discuss with the child's doctor whether there is a need for contraception.
Danish: Drøft med lægen, om det kan være relevant med prævention.
English: Mild to moderate renal impairment (eGFR <90 - ≥30 ml/min/1.73m2) doses should be reduced by 30% (see Table 2).
Danish: Ved let til moderat nedsat nyrefunktion (eGFR < 90 - ≥ 30 ml/min/1,73 m2) bør dosis reduceres med 30 % (se tabel 2).
English: Sialanar has moderate influence on the ability to drive and use machines.
Danish: Sialanar påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: − is allergic to glycopyrronium or any of the other ingredients of this medicine (listed in section
Danish: − er allergisk over for glycopyrronium eller et af de øvrige indholdsstoffer i Sialanar (angivet i punkt 6)
English: • neuroleptics/antipsychotics (clozapine, haloperidol, phenothiazine), used to treat some mental illnesses
Danish: • neuroleptika/antipsykotika (f.eks. clozapin, haloperidol og phenothiazin) til behandling af visse former for psykisk sygdom
English: Whilst clinical studies do not report any short or long-term effect of glycopyrronium on neurodevelopment or growth, no studies have been conducted to specifically address these issues.
Danish: Kliniske studier med glycopyrronium har ikke rapporteret kort- eller langsigtet indvirkning på neurologisk udvikling eller vækst, men der er ikke gennemført specifikke studier heraf.
English: There is limited clinical trial evidence on the use of glycopyrronium in the adult population with pathological drooling.
Danish: Der er kun begrænset dokumentation fra kliniske studier vedrørende anvendelse af glycopyrronium hos voksne med patologisk spytflåd.
English: Sialanar is a medicine that contains the active substance glycopyrronium.
Danish: Sialanar er et lægemiddel, der indeholder det aktive stof glycopyrronium.
English: The following medicinal product interaction information is relevant to glycopyrronium.
Danish: Nedenstående oplysninger om lægemiddelinteraktioner er relevante for glycopyrronium.
English: Such effects should be discussed with the carer during treatment reviews and a dose reduction considered.
Danish: Sådanne virkninger bør drøftes med omsorgspersonen i forbindelse med gennemgang af behandlingen, og i relevante tilfælde bør dosisreduktion overvejes.
English: • abnormal blood brain barrier (the layer of cells surrounding the brain)
Danish: • unormal blod-hjerne-barriere (cellelaget omkring hjernen)
English: Patients and/or parents/caregivers should be counselled to ensure an acurate dose is given each time, in order to prevent the harmful consequences of anticholinergic reactions of glycopyrronium seen with dosing errors or overdose.
Danish: Patienten og/eller forældrene/omsorgspersonen skal vejledes i altid at give den rigtige dosis, så skadelige følgevirkninger på grund af glycopyrroniums antikolinerge reaktioner ved forkert dosering eller overdosering undgås.
English: Concomitant use may result in increased intraocular pressure via an open- or a closed-angle mechanism;
Danish: Samtidig brug af et kortikosteroid kan medføre øget intraokulært tryk via en åbenvinklet eller snævervinklet mekanisme.
English: Gently pull down the plunger to the correct level (see the tables for the correct dose).
Danish: Træk forsigtigt stemplet nedad til den ønskede målestreg (se tabellerne for den korrekt dosis).
English: In adults, distribution of glycopyrronium was rapid following a single 6 µg/kg i.v.
Danish: Hos voksne var fordelingen af glycopyrronium hurtig efter en intravenøs enkeltdosis på 6 mikrogram/kg.
English: In the event of a known anticholinergic adverse event occurring when the dose is increased, the dose should be reduced to the previous lower dose and the event monitored.
Danish: Hvis der opstår en kendt antikolinerg bivirkning ved øgning af dosis, skal dosis reduceres til det forrige lavere niveau og bivirkningen overvåges.
English: BCM Limited
Danish: BCM Limited Thane Road
English: In rats at higher doses (1500-2000 mg/kg) tremors, clonic and tonic convulsions and laboured breathing were observed prior to death, resulting from respiratory failure.
Danish: Ved højere doser (1 5002 000 mg/kg) hos rotter sås tremor, kloniske og toniske kramper samt åndedrætsbesvær forud for død på grund af respirationssvigt.
English: Anticholinergic effects such as urinary retention, constipation and overheating due to inhibition of sweating may be dose dependent and difficult to assess in a disabled child.
Danish: Antikolinerge virkninger som f.eks. urinretention, obstipation og overophedning på grund af hæmmet svedafsondring kan være dosisafhængige og vanskelige at vurdere hos et handicappet barn.
English: 3.94 points (SD: 1.95; 95%; CI: 2.97-4.91)
Danish: (SD: 1,95; 95 % KI: 2,97; 4,91)
English: Published safety data are not available beyond 24 weeks treatment duration.
Danish: Mangel på sikkerhedsdata ved længerevarende behandling Der er ingen publicerede sikkerhedsdata vedrørende behandling i over 24 uger.
English: Glycopyrronium is contraindicated in pregnancy (see section 4.3).
Danish: Glycopyrronium er kontraindiceret under graviditet (se pkt.
English: BCM Ltd Nottingham NG90 2PR United Kingdom
Danish: Fremstiller BCM Ltd Nottingham NG90 2PR Storbritannien
English: Although glycopyrronium has limited ability to cross the blood brain barrier, increased central nervous system effects have been reported in clinical trials (23%).
Danish: Selvom glycopyrronium har en begrænset evne til at passere blod-hjerne-barrieren, er der rapporteret om stimulation af centralnervesystemet (23 %) i kliniske studier.
English: Mean improvements in mTDS
Danish: Gennemsnitlig forbedring på mTDS-skalaen
English: 2D barcode carrying the unique identifier included
Danish: Der er anført en 2D-stregkode, som indeholder den entydige identifikator.
English: This medicine is formulated as an oral formulation and a dose specifically for use in children and adolescents aged 3 years and older.
Danish: Dette lægemiddel fås i en oral (gennem munden) formulering og med en dosering, der passer specielt til børn og unge på 3 år og derover.
English: • kidney problems or difficulty passing urine
Danish: • nyreproblemer eller svært ved at lade vandet
English: • Information on the administration of Sialanar
Danish: • beskrivelse af, hvordan Sialanar administreres
English: It is supplied in a 60 ml or 250 ml amber glass bottle in a cardboard carton.
Danish: Lægemidlet leveres i en 60 ml eller 250 ml ravgul glasflaske i en æske af karton.
English: The carer should be advised to measure the pulse rate if the child seems unwell and report very fast or very slow heart rate.
Danish: Omsorgspersonen skal rådes til at tage barnets/den unges puls, hvis han/hun ser ud til at have det dårligt, og søge læge ved meget hurtig eller meget langsom hjertefrekvens.
English: The anticholinergic effects of glycopyrronium may cause blurred vision, dizziness and other effects that may impair a patient's ability to perform skilled tasks such as driving, riding a bicycle and using machines.
Danish: Glycopyrroniums antikolinerge virkninger kan give sløret syn, svimmelhed og andre bivirkninger, der kan nedsætte patientens evne til at udføre opmærksomhedskrævende opgaver som f.eks. at køre bil, cykle og betjene maskiner.
English: Where the child's specific needs determine that co-administration with food is required, dosing of the medicinal product should be consistently performed during food intake.
Danish: Hvis barnets/den unges særlige behov gør, at samtidigt indtagelse af mad er nødvendig, skal dosis indtages sammen med mad hver gang.
English: If you are not sure if any of the above applies to your child, talk to a doctor or pharmacist before giving Sialanar.
Danish: Hvis du er i tvivl, om noget af ovenstående gælder for barnet/den unge, skal du tale med lægen eller apotekspersonalet, før du begynder at give barnet/den unge Sialanar.
English: Raspberry flavouring (containing propylene glycol E1520) Sucralose (E955)
Danish: Hindbæraroma (indeholder propylenglycol E1520) Sucralose (E955)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING GLASS BOTTLE
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE GLASFLASKE
English: Zeller et al 2012a evaluated the efficacy of glycopyrronium bromide oral solution (1 mg/5 mL) in managing problem drooling associated with cerebral palsy and other neurologic conditions.
Danish: Zeller et al 2012a vurderede effekten af glycopyrroniumbromid i oral opløsning (1 mg/5 ml) til behandling af spytflåd hos patienter med cerebral parese eller andre neurologiske tilstande.
English: • pyrexia
Danish: • pyreksi
English: Corticosteroids: Steroid-induced glaucoma may develop with topical, inhaled, oral or intravenous, steroid administration.
Danish: Kortikosteroider: Steroid-induceret glaukom kan udvikles ved administration af topiske, inhalerede, orale eller intravenøse steroider.
English: These should be discussed with the child's doctor at all medical consultations, including those for dose increases and decreases, and at any other time should you be concerned.
Danish: Bivirkningerne skal drøftes ved alle besøg hos lægen, også ved de besøg, hvor dosis øges eller sættes ned, samt ved andre lejligheder, hvor du finder det relevant.