FrancophonIA/ELRC3.0 huggingface dataset:
English: Physostigmine salicylate is recommended when tachydysrhythmia with subsequent hemodynamic compromise, intractable seizure, severe agitation or psychosis is present.
Danish: Physostigminsalicylat anbefales, hvis patienten udviser takyarytmi med efterfølgende hæmodynamisk kompromittering, intraktable kramper, svær uro eller psykose.
English: Common manifestations include flushing, dry skin and mucous membranes, mydriasis with loss of accommodation, altered mental status and fever.
Danish: Almindelige manifestationer kan være ansigtsrødme (flushing), tør hud og tørre slimhinder, mydriasis med tab af akkomodationsevne, ændret mental tilstand og feber.
English: Do not give with high fat foods.
Danish: Undgå fødevarer med højt fedtindhold.
English: Central Nervous System
Danish: Centralnervesystemet
English: Nasogastric / feeding tubes, if used, should be flushed with 10 ml water immediately after dosing.
Danish: Hvis der anvendes sonde/næsesonde, skal den skylles med 10 ml vand umiddelbart efter administrationen.
English: An AUC0-6 h of 8.64 µg.h/L was observed after 6 µg/kg i.v.
Danish: En AUC0-6 t på 8,64 mikrogram∙time/l blev observeret efter en intravenøs dosis glycopyrronium på 6 mikrogram/kg.
English: Peripheral antimuscarinic effects that are produced as the dose increases are: decreased production of secretions from the salivary, bronchial and sweat glands; dilatation of the pupils (mydriasis) and paralysis of accommodation (cyclopegia); increased heart rate; inhibition of micturition and reduction in gastrointestinal tone; inhibition of gastric acid secretion.
Danish: Perifere antimuskarine virkninger, der ses ved dosisøgning: nedsat sekretion fra spyt-, bronkiale og svedkirtler, pupildilatation (mydriasis) og akkommodationsparalyse (cykloplegi), øget hjertefrekvens, miktionshæmning og reduceret gastrointestinal tonus, syresekretionshæmning.
English: Skeletal muscle relaxants: Use of anticholinergics after administration of botulinum toxin may potentiate systemic anticholinergic effects;
Danish: Muskelafslappende midler: Brug af antikolinergika efter administration af botulismetoksin kan potensere den systemiske antikolinerge virkning.
English: Data from sparse PK sampling in children suggests dose proportional PK.
Danish: Data fra sparsomme farmakokinetiske analyser hos børn tyder på dosisproportional farmakokinetik.
English: Fear
Danish: Angst
English: The PK of glycopyrronium has been shown to be essentially independent of age in children in the age range 0.19 - 14 years administered a 5 µg/kg i.v.
Danish: Det er vist, at glycopyrroniums farmakokinetik hos børn i det væsentlige er uafhængig af alder inden for intervallet 0,19-14 år ved en intravenøs enkeltdosis på 5 mikrogram/kg.
English: Most frequently reported treatment-emergent adverse events (glycopyrrolate vs placebo) were dry mouth, constipation, vomiting and nasal congestion.
Danish: De hyppigst rapporterede behandlingsrelaterede bivirkninger (glycopyrrolat vs. placebo) var mundtørhed, obstipation, opkastning og tilstoppet næse.
English: Sialanar 320 micrograms/ml oral solution Glycopyrronium
Danish: Sialanar 320 mikrogram/ml, oral opløsning Glycopyrronium
English: potassium chloride solid oral dose; anticholinergic medicines.
Danish: kaliumchlorid i oral fast lægemiddelform antikolinergika.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per maximum dose, i.e. essentially ‘sodium free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (det indeholder 23 mg) pr. maksimaldosis og er således stort set natriumfrit.
English: Effective contraception should be considered prior to treating women of childbearing age, where appropriate.
Danish: Forud for behandling af kvinder i den fertile alder skal brugen af sikker prævention drøftes, hvis det er relevant.
English: Other side effects that occur with anticholinergics but their frequency with glycopyrronium is not known
Danish: Andre bivirkninger ved antikolinerge lægemidler (hyppigheden i forbindelse med glycopyrronium er ikke kendt)
English: Within each system organ class, the adverse reactions are ranked by frequency, with the most frequent reactions first.
Danish: Inden for hver systemorganklasse er bivirkningerne listet efter, hvor hyppige de er.
English: This leaflet was last revised in Month YYYY Other sources of information
Danish: Denne indlægsseddel blev senest ændret {måned ÅÅÅÅ}.
English: Sialanar is used to treat excessive production of saliva (sialorrhoea) in children and adolescents aged 3 years and older.
Danish: Sialanar bruges til behandling af spytflåd (savlen eller kraftig spytproduktion) hos børn og unge på 3 år og derover.
English: Sialorrhoea (drooling or excessive salivation) is a common symptom of many diseases of the nerves and muscles.
Danish: Spytflåd er et almindeligt symptom ved mange sygdomme i nerver og muskler.
English: The active substance is glycopyrronium.
Danish: Aktivt stof: glycopyrronium.
English: Sodium benzoate (E211)
Danish: Natriumbenzoat (E211)
English: Dosing table for children and adolescents with mild to moderate renal impairment.
Danish: Doseringstabel for børn og unge med let til moderat nedsat nyrefunktion.
English: Safety in breast-feeding has not been established.
Danish: Amning Sikkerheden ved amning er ikke klarlagt.
English: Remove the child-resistant closure from the bottle.
Danish: Tag det børnesikrede låg af flasken.
English: Potassium chloride solid oral dose: glycopyrronium may potentiate the risk of upper gastrointestinal injury associated with oral solid formulations of potassium chloride due to increased gastrointestinal transit time creating a high localized concentration of potassium ions.
Danish: Kaliumchlorid i oral fast lægemiddelform: Glycopyrronium kan øge den risiko for skader i den øvre del af mave-tarm-kanalen, der er forbundet med kaliumchlorid i orale faste lægemiddelformer, på grund af en øget gastrointestinal transittid, hvilket giver en høj lokal koncentration af kaliumioner.
English: Other medicines and Sialanar
Danish: Brug af anden medicin sammen med Sialanar
English: If the child is given the medicinal product through a feeding tube, flush the tube with 10 ml of water after you have given the medicinal product.
Danish: Hvis barnet/den unge får lægemidlet gennem en sonde, skal sonden skylles med 10 ml vand, efter du har givet medicinen.
English: Sialanar must not be given if the patient is pregnant (or could be pregnant), or is breast-feeding (see section 2 ‘Do not give').
Danish: Sialanar må ikke anvendes hos en pige/en ung kvinde, hvis hun er (eller kan være) gravid eller ammer (se ovenstående punkt "Giv ikke Sialanar til barnet/den unge, hvis han/hun:" under punkt 2).
English: Anticholinergics: concomitant use of anticholinergics may increase the risk of anticholinergic side effects.
Danish: Antikolinergika: Samtidig brug af andre antikolinergika kan øge risikoen for antikolinerge bivirkninger.
English: 1 refers to µg/kg glycopyrronium
Danish: 1 µg/kg glycopyrronium
English: After first opening, use within 2 months.
Danish: Anvendes inden 2 måneder efter åbning.
English: The child should be monitored at regular intervals (at least every 3 months) to check that Sialanar is still the right treatment for them.
Danish: Barnet/den unge skal til kontrol hos lægen med regelmæssige mellemrum (mindst hver 3. måned), så det kan sikres, at Sialanar fortsat er det rigtige for barnet/den unge.
English: Insert the end of the oral syringe into the syringe adaptor and ensure it is secure.
Danish: Sæt spidsen af den orale sprøjte i sprøjteadapteren og sørg for, at den sidder ordentligt fast.
English: Increased central nervous system effects have been reported in clinical trials including: irritability; drowsiness; restlessness; overactivity; short attention span; frustration; mood changes; temper outbursts or explosive behaviour; excessive sensitivity; seriousness or sadness; frequent crying episodes; fearfulness.
Danish: I kliniske studier er der observeret øget påvirkning af centralnervesystemet, herunder irritabilitet, sløvhed, rastløshed, hyperaktivitet, nedsat opmærksomhedsevne, frustration, humørsvingninger, vredesudbrud eller raserianfald, usædvanlig følsomhed, dybsindighed eller tristhed, grådlabilitet og angst.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Concomitant use to be considered with caution Concomitant use of the following medicinal products should be considered with caution:
Danish: Samtidig brug, der kræver nøje overvejelse Samtidig brug af glycopyrronium og følgende lægemidler kræver nøje overvejelse:
English: Check that you have drawn up the correct level on the syringe before giving Sialanar.
Danish: Kontrollér, at du har trukket den rigtige mængde lægemiddel op i sprøjten, før du giver det til barnet/den unge.
English: • Allergic reaction (rash, itching, red raised itchy rash (hives), difficulty breathing or swallowing, dizziness) - frequency not known
Danish: • Allergisk reaktion (udslæt, kløe, nældefeber med rødt, hævet og kløende udslæt, besvær med at trække vejret eller synke, svimmelhed) - hyppighed ikke kendt
English: Each carton contains one bottle, one 8 ml oral syringe and one syringe adaptor.
Danish: Hver æske indeholder en flaske, en 8 ml oral sprøjte og en sprøjteadapter.
English: 6.6 Special precautions for disposal and other handling
Danish: 6.6 Regler for bortskaffelse og anden håndtering Brugervejledning
English: Glycopyrronium belongs to a group of medicines known as quaternary ammonium anticholinergics, which are agents that block or reduce the transmission between nerve cells.
Danish: Glycopyrronium er en kvaternær ammoniumforbindelse og tilhører en gruppe lægemidler, der kaldes antikolinergika, det vil sige stoffer, der nedsætter eller blokerer kommunikationen mellem cellerne.
English: Sialanar acts on the salivary glands to reduce production of saliva.
Danish: Sialanar påvirker spytkirtlerne, så produktionen af spyt nedsættes.
English: If your child gets any side effects, talk to your doctor or pharmacist.
Danish: Hvis barnet/den unge får bivirkninger, bør du tale med lægen, sygeplejersken eller apotekspersonalet.
English: Hold the oral syringe in place and turn the bottle upside down.
Danish: Hold den orale sprøjte på plads og vend bunden i vejret på flasken.
English: • pneumonia
Danish: • pneumoni
English: A reduction in anticholinergic and/or tricyclic antidepressants and MAOIs dosage may be necessary.
Danish: Det kan være nødvendigt at reducere dosis af antikolinergikum og/eller tricyklisk antidepressivum og MAOhæmmer.
English: Urinary retention is a known adverse reaction associated with anticholinergic medicinal products (15%).
Danish: Urinretention er en kendt bivirkning ved antikolinerge lægemidler (15 %).
English: A reduction in anticholinergic and/or neuroleptic/antipsychotic dose may be necessary;
Danish: Det kan være nødvendigt at reducere dosis af antikolinergikum og/eller neuroleptikum/antipsykotikum.
English: List of Adverse Reaction Frequency Adverse reactions
Danish: Liste over bivirkninger med angivelse af hyppighed
English: Skin and subcutaneous tissue disorders:
Danish: Hud og subkutane væv Udslæt
English: Pack size of one bottle, one 8 ml low density polyethylene oral syringe (0.1 ml graduations) and one syringe adaptor.
Danish: Pakningsstørrelse: en flaske med en 8 ml oral sprøjte (0,1 ml-målestreger) af lavdensitetspolyethylen og en sprøjteadapter.
English: Co-administration with food results in a marked decrease in systemic medicinal product exposure.
Danish: Samtidig indtagelse af mad giver en markant nedsat systemisk lægemiddeleksponering.
English: Check with the child's doctor during hot weather to see if the dose of Sialanar should be reduced.
Danish: I varmt vejr skal du få lægen til at vurdere, om Sialanar-dosen eventuelt skal nedsættes.
English: A reduction in anticholinergic and/or antihistamine dosage may be necessary;
Danish: Det kan være nødvendigt at reducere dosis af antikolinergikum og/eller antihistamin.
English: If you think a troublesome side effect is occurring after increasing a dose, the dose should be decreased to the previous one used and your doctor contacted.
Danish: Hvis du vurderer, at barnet/den unge får en generende bivirkning i forbindelse med øgning af dosis, skal du nedsætte dosen til det forrige niveau og kontakte lægen.
English: Acute sialorrhoea may be associated with inflammation, dental infections or infections of the mouth.
Danish: Akut spytflåd kan være forbundet med infektion i tænder eller inflammation (en betændelseslignende reaktion) eller betændelse i munden.
English: − If you have any further questions, ask your doctor or pharmacist.
Danish: Er du i tvivl, så spørg lægen eller sundhedspersonalet.
English: Warnings and precautions Talk to your doctor or pharmacist before using Sialanar if your child has:
Danish: Kontakt lægen eller apotekspersonalet, før du giver Sialanar til barnet/den unge, hvis han/hun har:
English: The primary route of elimination of glycopyrronium is via renal excretion, mainly as unchanged medicinal product.
Danish: Glycopyrronium udskilles primært renalt, fortrinsvis som uomdannet lægemiddel.
English: One 250 ml bottle One 8 ml oral syringe One syringe adaptor.
Danish: En 250 ml flaske En 8 ml oral sprøjte En sprøjteadapter.
English: • antispasmodics used to treat sickness or vomiting e.g.domperidone and metaclopramide
Danish: • medicin mod kramper i tarmen til behandling af kvalme og opkastning, som domperidon og metoclopramid
English: • Pneumonia (sever chest infection) - common
Danish: • Lungebetændelse - almindelig
English: Sialanar should be taken by mouth.
Danish: Indgivelsesvej Sialanar indgives gennem munden.
English: • dry skin;
Danish: • Tør hud
English: Ask your doctor if you need further advice.
Danish: Spørg lægen til råds, hvis der er noget, du er i tvivl om.
English: Constipation is a known adverse reaction associated with anticholinergic medicinal products (30%).
Danish: Obstipation er en kendt bivirkning ved antikolinerge lægemidler (30 %).
English: Non-clinical data, including genotoxicity or carcinogenicity studies have not been performed for
Danish: Der foreligger ingen prækliniske data for Sialanar fra genotoksicitets- eller karcinogenicitetsstudier.
English: Sialanar 320 micrograms /ml oral solution
Danish: LÆGEMIDLETS NAVN Sialanar 320 mikrogram/ml, oral opløsning
English: Responder rate was defined as at least a 3-point improvement in modified Teacher's Drooling Scale (mTDS).
Danish: Respons var defineret som en forbedring på mindst 3 point på mTDS-skalaen.
English: Since reduced salivation can increase the risk of oral cavities and periodontal diseases, it is important that patients receive adequate daily dental hygiene and regular dental health checks.
Danish: Da reduceret spytsekretion kan øge risikoen for sygdomme i mundhule og parodontium, er det vigtigt, at patientens daglige mundhygiejne passes, og at patienten regelmæssigt kommer til tandlægen.
English: Each ml of solution contains 400 micrograms glycopyrronium bromide equivalent to 320 micrograms glycopyrronium.
Danish: Hver ml opløsning indeholder 400 mikrogram glycopyrroniumbromid svarende til 320 mikrogram glycopyrronium.
English: Remove the oral syringe by holding the bottle and twisting the oral syringe gently.
Danish: Hold om flasken og fjern den orale sprøjte ved at vride den forsigtigt af.
English: − This medicine has been prescribed for your child only.
Danish: − Lægen har ordineret dette lægemiddel til barnet/den unge personligt.
English: • digestive disorders (constipation; chronic heartburn and indigestion)
Danish: • fordøjelsesproblemer (forstoppelse, kronisk halsbrand og andet fordøjelsesbesvær)
English: This medicine contains 2.3 mg benzoate salt (E211) in each ml.
Danish: Dette lægemiddel indeholder 2,3 mg benzoat (E211) i hver ml.
English: • corticosteroids, used to treat inflammatory diseases
Danish: • kortikosteroider til behandling af inflammatoriske sygdomme (betændelseslignende tilstande)
English: As a consequence of its quaternary charge glycopyrronium has limited ability to penetrate the blood brain barrier, although the extent of penetration is unknown.
Danish: Da glycopyrronium er en kvaternær ammoniumforbindelse, har lægemidlet kun begrænset evne til at passere blod-hjerne-barrieren, men graden af passage er ikke kendt.
English: − is pregnant or breast feeding
Danish: − for piger: hvis hun er gravid eller ammer
English: Use while breast-feeding is contraindicated (see section 4.3).
Danish: Brug under amning er kontraindiceret (se pkt.
English: Contains sodium benzoate (E211).
Danish: Indeholder natriumbenzoat (E211).
English: Co-administration with food results in a marked decrease in systemic glycopyrronium exposure.
Danish: Samtidig indtagelse af mad giver en markant nedsat systemisk eksponering for glycopyrronium.
English: That the latter two half-lives, and especially that for oral administration, are longer than for i.v.
Danish: At halveringstiden ved de to sidstnævnte administrationsveje, navnlig halveringstiden ved oral administration, er længere end ved intravenøs administration, afspejler formodentlig glycopyrroniums komplekse absorption og fordeling ved disse to administrationsveje.
English: Short attention span
Danish: Nedsat opmærksomhedsevne
English: Each ml contains 2.3 mg sodium benzoate (E211).
Danish: Hver ml indeholder 2,3 mg natriumbenzoat (E211).
English: The safety profile is further characterised by other symptoms, related to the anticholinergic effects at a rate of ≥15%, including urinary retention, flushing and nasal congestion.
Danish: relateret til antikolinerge virkninger, med en hyppighed ≥ 15 %, herunder urinretention, ansigtsrødme og tilstoppet næse.
English: − is unable to completely empty the bladder (urinary retention)
Danish: − er ude af stand til at tømme blæren
English: Sodium benzoate This medicinal product contains 2.3 mg sodium benzoate (E211) in each ml.
Danish: Natriumbenzoat Dette lægemiddel indeholder 2,3 mg natriumbenzoat (E211) i hver ml.
English: Co-administration with food results in a marked decrease in systemic glycopyrronium exposure (see section 4.2.
Danish: Samtidig indtagelse af mad giver en markant nedsat systemisk eksponering for glycopyrronium (se pkt.
English: Place the oral syringe inside the child's mouth and press the plunger slowly to gently release the medicinal product.
Danish: Før den orale sprøjte ind i barnets/den unges mund og tryk langsomt på stemplet, så lægemidlet sprøjtes ind i munden.
English: Contraindications of concomitant use Concomitant use of the following medicinal products is contraindicated (see section 4.3):
Danish: Kontraindikation for samtidig anvendelse Samtidig brug af glycopyrronium og følgende lægemidler er kontraindiceret (se pkt.
English: The assessment of reproductive endpoints for glycopyrronium is limited (see section 5.3).
Danish: Der foreligger kun få vurderinger af reproduktionsrelaterede effektmål for glycopyrronium (se pkt.
English: Renal and urinary disorders
Danish: Nyrer og urinveje Urinretention
English: The elimination half-life of glycopyrronium appears to be dependent on route of administration being 0.83 ± 0.27 hours after i.v.
Danish: Glycopyrroniums eliminationshalveringstid synes at være afhængig af administrationsvejen, idet den var 0,83 ± 0,27 timer efter intravenøs administration, 75 minutter efter intramuskulær administration og omkring 2,5-4 timer efter oral administration (opløsning), selvom der var store variationer.
English: If they occur, take the child to the nearest emergency medical facility and take the medicine with you.
Danish: Hvis barnet/den unge får disse bivirkninger, skal du sørge for at transportere ham/hende til nærmeste hospital eller lægevagt og medbringe lægemidlet.
English: Additional manifestations include sinus tachycardia, decreased bowel sounds, functional ileus, urinary retention, hypertension, tremulousness and myoclonic jerking.
Danish: Andre manifestationer kan være sinustakykardi, nedsatte tarmlyde, paralytisk ileus, urinretention, hypertension, skælven og myokloniske spjæt.
English: • raised pressure in the eye (which might cause glaucoma); photophobia (sensitivity to light);
Danish: • Forhøjet tryk i øjet (kan give grøn stær), øget lysfølsomhed, tørre øjne
English: If any of the following serious side effects occur, stop using the medicine and seek urgent medical advice.
Danish: Hvis barnet/den unge får en eller flere af følgende alvorlige bivirkninger, skal du straks stoppe behandlingen og søge lægehjælp.
English: Pregnancy and breast-feeding.
Danish: Graviditet og amning.
English: • Difficulty in passing urine (urinary retention) - very common
Danish: • Besvær med vandladningen - meget almindelig
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG
English: What you need to know before you give Sialanar Do not give Sialanar if the child or adolescent:
Danish: Det skal du vide, før du begynder at give Sialanar til barnet/den unge
English: Respiratory, thoracic and mediastinal disorders
Danish: Luftveje, thorax og mediastinum Tilstoppet næse
English: Instructions for use How to use the oral syringe
Danish: Sådan anvender du den orale sprøjte
English: The most common anticholinergic adverse reactions in the placebo-controlled studies (see section 5.1) related to the gastrointestinal system and were dry mouth, constipation, diarrhoea and vomiting, all of which occurred at a rate of ≥15%.
Danish: 5.1) var gastrointestinale gener som mundtørhed, obstipation, diarré og opkastning, som alle havde en hyppighed ≥ 15 %.
English: • Agitation
Danish: • Ophidselse
English: You can also report side effects directly via the national reporting system listed in Appendix V.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Glycopyrronium treatment should be withdrawn until the urinary retention resolves.
Danish: Behandlingen med glycopyrronium skal afbrydes, indtil urinretentionen har fortaget sig.
English: The adverse event profile was consistent with the one seen with anticholinergics (see section 4.4 and 4.8).
Danish: Bivirkningsprofilen var konsistent med bivirkningsprofilen for antikolinergika (se pkt.
English: An association with upper GI bleeding and small bowel ulceration, stenosis, perforation, and obstruction has been observed.
Danish: Der er set en sammenhæng mellem obstruktion og øvre gastrointestinal blødning, ulceration i tyndtarmen, stenose og perforation.
English: Based upon theoretical physicochemical considerations, the quaternary ammonium compound glycopyrronium would be expected to have low central bioavailability; no glycopyrronium was detectable in the CSF of anaesthetised surgical patients or patients undergoing caesarean section following a 6 - 8 µg/kg i.v.
Danish: Efter en intravenøs dosis på 68 mikrogram/kg kunne glycopyrronium ikke detekteres i cerebrospinalvæsken hos bedøvede kirurgiske patienter eller patienter, der fik foretaget kejsersnit.
English: • Constipation (difficulty in passing stool) - very common
Danish: • Forstoppelse - meget almindelig
English: Amber coloured glass bottle with a high density polyethylene tamper evident child resistant closure with expanded low density polyethylene liner.
Danish: Ravgul glasflaske, der har et børnesikret og anbrudssikret låg af højdensitetspolyethylen med foring af ekspanderet lavdensitetspolyethylen.
English: • At the request of the European Medicines Agency;
Danish: • på anmodning fra Det Europæiske Lægemiddelagentur • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger,