FrancophonIA/ELRC3.0 huggingface dataset:
English: After a single dose of oromucosal midazolam, the consequence on the maximal clinical effect due to CYP3A4 inhibition will be minor while the duration of effect may be prolonged.
Danish: Efter en enkelt dosis af midazolam indgivet via mundhulen vil konsekvensen af den maksimale kliniske virkning, der skyldes CYP3A4-hæmmere, være af mindre betydning, mens virkningens varighed kan være forlænget.
English: Co-administration with protease inhibitors (e.g. Saquinavir and other HIV protease inhibitors) may cause a large increase in the concentration of midazolam.
Danish: Indgivelse sammen med proteasehæmmere (f.eks. Saquinavir og andre HIV-proteasehæmmere) kan forårsage en stor forøgelse i koncentrationen af midazolam.
English: Always check with them if you are not sure.
Danish: Er du i tvivl, så spørg dem altid.
English: • The child is sick (vomits) and the seizure does not stop within 10 minutes
Danish: • Barnet kaster op, og krampeanfaldet ikke stopper i løbet af 10 minutter
English: Hydrochloric acid (for pH adjustment and conversion of midazolam to the hydrochloride salt) Sodium hydroxide (for pH adjustment)
Danish: Saltsyre (til pH-justering og omdannelse af midazolam til hydrochloridsaltet) Natriumhydroxid (til pH-justering)
English: • xanthines (used to treat asthma)
Danish: • xanthiner (anvendes til behandling af astma)
English: • medicines used to reduce fat in the blood, e.g. atorvastatin
Danish: • medicin, der anvendes til at reducere fedt i blodet, f.eks. atorvastatin
English: > 6 months to < 1 year
Danish: >6 måneder til <1 år
English: Pharmacokinetic interactions with CYP3A4 inhibitors or inducers are more pronounced for oral as compared to oromucosal or parenteral midazolam as CYP3A4 enzymes are also present in the upper gastro-intestinal tract.
Danish: Farmakokinetiske interaktioner med CYP3A4-hæmmere eller -inducere er mere udpræget for midazolam indgivet oralt sammenlignet med indgivelse via mundhulen eller parenteral indgivelse, da CYP3A4-enzymer også er til stede i den øvre del af mave-tarm-kanalen.
English: • Reduced alertness
Danish: • Nedsat opmærksomhed
English: Medical history of alcohol or drug abuse
Danish: Anamnese af alkohol- eller stofmisbrug
English: • The child's breathing slows down or stops e.g. slow or shallow breathing or blue lips
Danish: • Barnets vejrtrækning bliver langsommere eller stopper, f.eks. langsom eller overfladisk vejrtrækning eller blå læber
English: Uncommon: Pruritus, rash and urticarial
Danish: Ikke almindelig: Pruritus, udslæt og urticaria
English: Each syringe is for single use only.
Danish: Hver sprøjte er kun til engangsbrug.
English: Midazolam may interact with other hepatically metabolised medicinal products, e.g. phenytoin, causing potentiation.
Danish: Midazolam kan påvirke andre lægemidler, der metaboliseres via leveren, f.eks. phenytoin, hvilket forårsager potensering.
English: The table below lists the adverse reactions reported to occur when oromucosal midazolam was administered to children in clinical studies.
Danish: Den nedenstående tabel opstiller de bivirkninger, der blev rapporteret, når midazolam til anvendelse i mundhulen blev indgivet til børn i kliniske studier.
English: Tell the doctor if the patient is breast-feeding.
Danish: Fortæl det til lægen, hvis patienten ammer.
English: BUCCOLAM may increase the effect of some muscle relaxants e.g. baclofen (causing increased drowsiness).
Danish: BUCCOLAM kan forstærke virkningen af nogle muskelafslappende lægemidler, f.eks. baclofen (og forårsage øget døsighed).
English: The clearance is not significantly different in obese and non-obese patients.
Danish: Clearance er ikke signifikant forskellig hos svært overvægtige patienter, sammenlignet med patienter, der ikke er svært overvægtige.
English: Alcohol may increase the sedative effects of this medicine and make them very sleepy.
Danish: Alkohol kan forstærke den sløvende virkning af dette lægemiddel og gøre patienten meget søvnig.
English: Hold the plastic tube, break the seal at one end and pull the cap off. Take the syringe out of the tube.
Danish: Hold om plastictuben, bryd forseglingen i den ene ende og træk hætten af.
English: Always give this medicine exactly as a doctor has told you.
Danish: Giv altid lægemidlet nøjagtigt efter lægens anvisning.
English: The co-administration of midazolam with other sedative/hypnotic medicinal products and CNS depressants, including alcohol, is likely to result in enhanced sedation and respiratory depression.
Danish: Samtidig indgivelse af midazolam og andre sederende/hypnotiske lægemidler og CNS-deprimerende midler, herunder alkohol, kan sandsynligvis resultere i forøget sedation og respirationsdepression.
English: The steady state volume of distribution following oromucosal administration is estimated to be 5.3 l/kg.
Danish: Steady-state fordelingsvolumen efter indgivelse via mundhulen er estimeret til 5,3 l/kg.
English: Medicinal products that induce CYP3A4
Danish: Lægemidler, der inducerer CYP3A4
English: Hepatic impairment reduces the clearance of midazolam with a subsequent increase in terminal halflife.
Danish: En nedsat leverfunktion reducerer clearance af midazolam med en efterfølgende forøgelse af den terminale halveringstid.
English: Midazolam may cause potentiation of muscle relaxants, with increased CNS depressant effects.
Danish: Midazolam kan forårsage potensering af muskelrelaksantia, med forhøjede CNSundertrykkende virkninger.
English: Amber, pre-filled needle-free oral syringe (polypropylene) with plunger (polypropylene) and end cap (high density polyethylene) packed in a protective, capped plastic tube.
Danish: 6.5 Emballagetype og pakningsstørrelser Ravfarvet fyldt kanylefri oral sprøjte (polypropylen) med stempel (polypropylen) og hætte (højdensitets polyethylen), pakket i en beskyttende plastictube med hætte.
English: No dose adjustment is required, however, BUCCOLAM should be used with caution in patients with chronic renal failure as elimination of midazolam may be delayed and the effects prolonged.
Danish: En dosisjustering er ikke nødvendig, men BUCCOLAM skal dog anvendes med forsigtighed hos patienter med kronisk nyreinsufficiens, da eliminationen af midazolam kan være forsinket, og virkningen kan være forlænget (se pkt.
English: Midazolam may cause anterograde amnesia.
Danish: Midazolam kan forårsage anterograd amnesi.
English: • This medicine has been prescribed for your child. Do not pass it on to others.
Danish: • Lægen har ordineret dette lægemiddel til dit barn.
English: Xanthines
Danish: Xanthiner
English: Keep the oral syringe in the protective plastic tube.
Danish: Opbevar den orale sprøjte i den beskyttende plastictube.
English: BUCCOLAM is available in cartons containing 4 pre-filled syringes.
Danish: BUCCOLAM forefindes i kartoner, der indeholder 4 fyldte, orale sprøjter.
English: The elimination half-life in cirrhotic patients may be longer and the clearance lower as compared to those in healthy volunteers (see section 4.4).
Danish: Eliminationshalveringstiden hos patienter med cirrose kan være længere, og clearance kan være lavere sammenlignet med værdierne for raske frivillige studiepersoner (se pkt.
English: The effect of CYP3A4 inhibitors may be larger in infants since part of the oromucosal dose is probably swallowed and absorbed in the gastro-intestinal tract.
Danish: Virkningen af CYP3A4-hæmmere kan være større hos spædbørn, da dele af den indgivne dosis i mundhulen sandsynligvis sluges og absorberes i mave-tarm-kanalen.
English: Grapefruit juice may increase the sedative effects of this medicine and make them very sleepy.
Danish: Grapefrugtjuice kan forstærke den sløvende virkning af dette lægemiddel og gøre patienten meget søvnig.
English: Put the tip of the syringe into the back of the space between the inside of the cheek and the lower gum.
Danish: Sæt spidsen af sprøjten ind bagest i hulrummet mellem indersiden af kinden og gummerne forneden.
English: • You give too much BUCCOLAM and there are signs of overdose which include: o Drowsiness, tiredness, fatigue o Confusion or feeling disorientated o Absence of knee reflex or a response to a pinch o Breathing difficulties (slow or shallow breathing) o Low blood pressure (giddiness and feeling faint) o Coma
Danish: • Du giver for meget BUCCOLAM, og der er tegn på overdosering, som omfatter: o Døsighed, træthed, udmattethed o Forvirring eller desorientering o Ingen knærefleks eller respons på at blive knebet o Vejrtrækningsbesvær (langsom eller overfladisk vejrtrækning) o Lavt blodtryk (omtågethed og følelse af at besvime) o Koma
English: BUCCOLAM oromucosal solution is a clear colourless liquid.
Danish: BUCCOLAM mundhulevæske, opløsning, er en klar, farveløs væske.
English: E.g. baclofen.
Danish: F.eks. baclofen.
English: Midazolam may cause inhibition of levodopa.
Danish: Midazolam kan forårsage hæmning af levodopa.
English: Ulcer-healing medicinal products
Danish: Ulcus-helende lægemidler
English: BUCCOLAM is contraindicated in patients with severe hepatic impairment (see section 4.3).
Danish: BUCCOLAM er kontraindiceret hos patienter med svært nedsat leverfunktion (se pkt.
English: Grapefruit juice reduces the clearance of midazolam and potentiates its action.
Danish: Grapefrugtjuice reducerer clearance af midazolam og potenserer dets virkning.
English: Uncommon: ≥ 1/1,000 to < 1/100
Danish: Ikke almindelig: ≥ 1/1.000 til < 1/100 Meget sjælden: < 1/10.000
English: When to call an ambulance ALWAYS follow the treatment advice provided by the patient's doctor or as explained by a healthcare professional.
Danish: Du skal ALTID følge de behandlingsråd, som patientens læge har givet dig, eller følge sundhedspersonalets instruktioner.
English: Midazolam should be used with caution in patients with chronic respiratory insufficiency because midazolam may further depress respiration.
Danish: Midazolam skal anvendes med forsigtighed hos patienter med kronisk respirationsinsufficiens, da midazolam kan føre til yderligere respirationsdepression.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness:
Danish: Inden for hver enkelt frekvensgruppe skal bivirkningerne opstilles efter, hvor alvorlige de er.
English: Midazolam may accumulate in patients with chronic renal failure or impaired hepatic function whilst in patients with impaired cardiac function it may cause decreased clearance of midazolam.
Danish: Midazolam kan akkumuleres hos patienter med kronisk nyresvigt eller nedsat leverfunktion , mens det hos patienter med nedsat hjertefunktion kan forårsage nedsat clearance af midazolam.
English: Using the finger and thumb gently pinch and pull back the child's cheek.
Danish: Klem forsigtigt om barnets kind med tommel- og pegefinger og træk kinden bagud.
English: Label colour
Danish: Etiketfarve
English: A single dose of diltiazem increased the plasma concentrations of intravenous midazolam by about 25% and the terminal half-life was prolonged by 43%.
Danish: En enkelt dosis af diltiazem forøgede plasmakoncentrationerne af intravenøs midazolam med ca. 25 %, og den terminale halveringstid var forlænget med 43 %.
English: Diltiazem and verapamil have been shown to reduce the clearance of midazolam and other benzodiazepines and may potentiate their actions.
Danish: Diltiazem og verapamil har vist sig at reducere clearance af midazolam og andre benzodiazepiner og kan potensere deres virkninger.
English: 10 years to < 18 years
Danish: 10 år til <18 år
English: 4 pre-filled oral syringes
Danish: 4 fyldte orale sprøjter
English: Azole antifungals
Danish: Azol-antimykotika
English: Muscle relaxants
Danish: Muskelrelaksantia
English: • Severe breathing difficulties e.g. slow or shallow breathing or blue lips.
Danish: • Alvorligt vejrtrækningsbesvær, f.eks. langsom eller overfladisk vejrtrækning eller blå læber.
English: After oromucosal administration midazolam is absorbed rapidly.
Danish: Efter indgivelse via mundhulen absorberes midazolam hurtigt.
English: It is supplied in an amber coloured prefilled, single-use oral syringe.
Danish: Det leveres i en ravfarvet fyldt, oral sprøjte til engangsbrug.
English: What BUCCOLAM looks like and contents of the pack 3 months to less than 1 year: 2.5 mg - yellow labelled packaging 1 year to less than 5 years: 5 mg - blue labelled packaging 5 years to less than 10 years: 7.5 mg - purple labelled packaging 10 years to less than 18 years: 10 mg - orange labelled packaging
Danish: Udseende og pakningsstørrelser 3 måneder til under 1 år: 2,5 mg - pakning med gul etiket 1 år til under 5 år: 5 mg - pakning med blå etiket 5 år til under 10 år: 7,5 mg - pakning med lilla etiket 10 år til under 18 år: 10 mg - pakning med orange etiket
English: Sedation, somnolence, depressed levels of consciousness Respiratory depression
Danish: Sedation, somnolens, nedsat bevidsthed Respirationsdepression Meget sjælden:
English: Midazolam should be used with caution in patients with chronic renal failure, impaired hepatic or cardiac function.
Danish: Midazolam skal anvendes med forsigtighed hos patienter med kronisk nyresvigt, nedsat lever- eller hjertefunktion.
English: These produce a stable solution suitable for oromucosal administration.
Danish: Dette giver en stabil opløsning, der er velegnet til indgivelse via mundhulen.
English: Atorvastatin showed a 1.4-fold increase in plasma concentrations of intravenous midazolam compared to control group.
Danish: Atorvastatin viste en forøgelse af plasmakoncentrationerne af intravenøs midazolam på 1,4 gange, sammenlignet med kontrolgruppen.
English: Cimetidine, ranitidine and omeprazole have been shown to reduce the clearance of midazolam and other benzodiazepines and may potentiate their actions.
Danish: Cimetidin, ranitidin og omeprazol har vist sig at reducere clearance af midazolam og andre benzodiazepiner og kan potensere deres virkninger.
English: Fluconazole and itraconazole both increased the plasma concentrations of intravenous midazolam by 2 to 3-fold associated with an increase in terminal half-life by 2.4-fold for itraconazole and 1.5-fold for fluconazole.
Danish: Fluconazol og itraconazol forøgede begge plasmakoncentrationerne af intravenøs midazolam med 2-3 gange i forbindelse med en forøgelse i terminal halveringstid med 2,4 gange for itraconazol og 1,5 for fluconazol.
English: What BUCCOLAM contains
Danish: BUCCOLAM indeholder:
English: • An illness causing frequent interruption of breathing during sleep (sleep apnoea syndrome)
Danish: • En sygdom, der forårsager, at vejrtrækningen afbrydes under søvn (søvnapnø-syndrom) • Alvorlige leverproblemer.
English: Uncommon side effects (may affect up to 1 in 100 people): • Rash, hives (lumpy rash), itchiness
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 personer): • Udslæt, nældefeber (ujævnt udslæt), kløe
English: Strength Volume of solution
Danish: Volumen af opløsningen
English: • A kidney, liver or heart condition
Danish: • En nyre-, lever- eller hjertesygdom
English: Constipation**, dry mouth**
Danish: Forstoppelse**, mundtørhed**
English: BUCCOLAM 5 mg, 7.5 mg, 10 mg oromucosal solution 2 years
Danish: BUCCOLAM 5 mg, 7,5 mg, 10 mg mundhulevæske, opløsning 2 år.
English: This medicine should be avoided in patients with a medical history of alcohol or drug abuse.
Danish: Dette lægemiddel skal undgås til patienter, som har eller tidligere har haft et alkohol- eller stofmisbrug.
English: The full amount of solution should be inserted slowly into the space between the gum and the cheek.
Danish: Hele opløsningen skal indsættes langsomt i hulrummet mellem gummerne og kinden.
English: Midazolam is hydroxylated by the cytochrome P4503A4 isozyme and the major urinary and plasma metabolite is alpha-hydroxy-midazolam.
Danish: Fraktionen af den dosis, der blev ekstraheret af leveren, er blevet estimeret til 30-60 % Midazolam hydroxyleres af cytokrom P4503A4-isozymet, og den største metabolit i urin og plasma er alfa-hydroxy-midazolam.
English: Nabilone
Danish: Nabilon
English: 5 years to < 10 years
Danish: 5 år til <10 år
English: The elimination half-life in patients with chronic renal failure is similar to that in healthy volunteers.
Danish: Eliminationshalveringstiden for patienter med kronisk nyresvigt er sammenlignelig med halveringstiden for raske frivillige studiepersoner.
English: 1 year to < 5 years
Danish: 1 år til <5 år
English: Remove the oral syringe cap before use.
Danish: Fjern hætten fra den orale sprøjte før brug.
English: AUC0-inf (ng.h/ml) Cmax (ng/ml) 10 mg 10 yrs < 18 yrs AUC0-inf (ng.h/ml) Cmax (ng/ml)
Danish: 10 mg 10 år < 18 år AUC0-inf (ng.t/ml) Cmax (ng/ml)
English: Posaconazole increased the plasma concentrations of intravenous midazolam by about 2-fold.
Danish: Posaconazol førte til ca. en fordobling af plasmakoncentrationerne af intravenøs midazolam.
English: Cardiac insufficiency
Danish: Hjerteinsufficiens
English: • medicines used to treat nausea, e.g. nabilone
Danish: • medicin, der anvendes til at behandle kvalme, f.eks. nabilon
English: Upon co-administration with ritonavirboosted lopinavir, the plasma concentrations of intravenous midazolam increased by 5.4-fold, associated with a similar increase in terminal half-life.
Danish: Ved indgivelse sammen med ritonavirboostet lopinavir var plasmakoncentrationerne af intravenøst midazolam forøget 5,4 gange i forbindelse med en lignende stigning i den terminale halveringstid.
English: Co-administration with midazolam may cause enhanced sedation or respiratory or cardiovascular depression.
Danish: Indgivelse sammen med midazolam kan forårsage forøget sedation eller respirations- eller kardiovaskulær depression.
English: The elimination half-life is longer in patients with congestive heart failure compared with that in healthy subjects (see section 4.4).
Danish: Eliminationshalveringstiden er længere hos patienter med kronisk hjerteinsufficiens, sammenlignet med halveringstiden for raske personer (se pkt.
English: For children aged 10 years to less than 18 years
Danish: For børn i alderen 10 år til under 18 år
English: • anti-ulcer medicines, e.g. cimetidine, ranitidine and omeprazole
Danish: • medicin mod mavesår, f.eks. cimetidin, ranitidin og omeprazol
English: • medicines used to treat blood pressure, e.g. diltiazem, verapamil
Danish: • medicin, der anvendes til at kontrollere blodtrykket, f.eks. diltiazem, verapamil
English: Yellow
Danish: Gul
English: Co-administration with midazolam may cause enhanced sedation or respiratory and cardiovascular depression.
Danish: Indgivelse sammen med midazolam kan forårsage forøget sedation eller respirations- og kardiovaskulær depression.
English: Check with a doctor or pharmacist if you are not sure.
Danish: Spørg lægen eller apotekspersonalet, hvis der er noget, du er i tvivl om.
English: Voriconazole increased the exposure of intravenous midazolam by 3-fold whereas its elimination halflife increased by about 3-fold.
Danish: Voriconazol tredoblede eksponeringen over for intravenøs midazolam, mens eliminationshalveringstiden blev ca. tredoblet.
English: If the child is having a seizure, allow their body to move freely, do not try to restrain them.
Danish: Hvis barnet har et krampeanfald, skal dets krop kunne bevæge sig frit.
English: Dopaminergic medicinal products
Danish: Dopaminerge lægemidler
English: BUCCOLAM is for oromucosal use.
Danish: BUCCOLAM er til anvendelse i mundhulen.
English: Hypersensitivity to the active substance, benzodiazepines or to any of the excipients listed in section Myasthenia gravis
Danish: Overfølsomhed over for det aktive stof, benzodiazepiner eller over for et eller flere af hjælpestofferne anført i pkt.
English: Life-threatening incidents are more likely to occur in those with pre-existing respiratory insufficiency or impaired cardiac function, particularly when a high dosage is administered (see section 4.4).
Danish: Livstruende hændelser har større tendens til at forekomme hos patienter med eksisterende respirationsinsufficiens eller nedsat hjertefunktion, især når der indgives en høj dosis (se pkt.
English: The full amount of solution should be inserted slowly into the space between the gum and the cheek (buccal cavity).
Danish: Al mundhulevæske skal sprøjtes langsomt ind i hulrummet mellem gummerne og kinden (det bukkale hulrum).
English: St John's Wort decreased plasma concentrations of midazolam by about 20-40% associated with a decrease in terminal half life of about 15-17%.
Danish: Perikon reducerede plasmakoncentrationen af midazolam med ca. 20-40 %, hvilket er forbundet med en reduktion i den terminale halveringstid på ca. 15-17 %.
English: Erythromycin resulted in an increase in the plasma concentrations of intravenous midazolam by about 1.6 to 2 -fold associated with an increase of the terminal half-life of midazolam by 1.5 to 1.8-fold.
Danish: Erythromycin resulterede i en forøgelse af plasmakoncentrationerne af intravenøs midazolam med ca. 1,6 til 2 gange i forbindelse med en forøgelse af den terminale halveringstid med 1,5 til 1,8 gange.
English: Remove the oral syringe cap before use to avoid risk of choking.
Danish: Fjern hætten fra den orale sprøjte før brug for at undgå risikoen for kvælning.
English: BUCCOLAM 2.5 mg oromucosal solution BUCCOLAM 5 mg oromucosal solution BUCCOLAM 7.5 mg oromucosal solution BUCCOLAM 10 mg oromucosal solution
Danish: BUCCOLAM 2,5 mg mundhulevæske, opløsning BUCCOLAM 5 mg mundhulevæske, opløsning BUCCOLAM 7,5 mg mundhulevæske, opløsning BUCCOLAM 10 mg mundhulevæske, opløsning
English: For children aged 3 months to less than 1 year
Danish: For børn i alderen 3 måneder til under 1 år
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2.5 mg
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 2,5 mg
English: 3 months to less than 1 year: 2.5 mg - yellow labelled packaging 1 year to less than 5 years: 5 mg - blue labelled packaging 5 years to less than 10 years: 7.5 mg - purple labelled packaging 10 years to less than 18 years: 10 mg - orange labelled packaging The dose is the full contents of one oral syringe.
Danish: 5 år til under 10 år: 7,5 mg - pakning med lilla etiket 10 år til under 18 år: 10 mg - pakning med orange etiket Dosis er hele indholdet i en oral sprøjte.
English: Clarithromycin increased the plasma concentrations of intravenous midazolam by up to 2.5-fold associated with an increase in terminal half-life by 1.5 to 2-fold.
Danish: Clarithromycin forøgede plasmakoncentrationerne af intravenøs midazolam med op til 2,5 gange i forbindelse med en forøgelse af den terminale halveringstid med 1,5 til 2 gange.
English: For children aged 3 months to less than 1 year For oromucosal use only.
Danish: For børn i alderen 3 måneder til under 1 år Kun til anvendelse i mundhulen.
English: BUCCOLAM 10 mg oromucosal solution For children aged 10 years to less than 18 years
Danish: BUCCOLAM 10 mg mundhulevæske, opløsning For børn i alderen 10 år til under 18 år
English: HIV Protease inhibitors
Danish: HIV-proteasehæmmere
English: For children aged 1 year to less than 5 years
Danish: For børn i alderen 1 år til under 5 år
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 05 September 2011
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Disposal of oral syringes
Danish: Bortskaffelse af orale sprøjter:
English: MARKETING AUTHORISATION NUMBER(S) BUCCOLAM 2.5 mg oromucosal solution EU/1/11/709/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) BUCCOLAM 2,5 mg mundhulevæske, opløsning EU/1/11/709/001
English: For infants between 3-6 months of age treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available.
Danish: For spædbørn i alderen 3-6 måneder skal behandlingen foregå i hospitalsregi, hvor overvågning er mulig og genoplivningsudstyr er til rådighed.
English: • anaesthetics (for pain relief)
Danish: • anæstetika (til smertelindring)
English: For children aged 5 years to less than 10 years
Danish: For børn i alderen 5 år til under 10 år
English: Toddlers aged from 3 months to less than 6 months should only be treated in a hospital setting where monitoring is possible and resuscitation equipment is available.
Danish: Småbørn i alderen fra 3 måneder til under 6 måneder må kun behandles på hospital, hvor overvågning er mulig, og genoplivningsudstyr er til rådighed.