FrancophonIA/ELRC3.0 huggingface dataset:
English: In adult male rats, repeated administration of propranolol at high dose levels (≥7.5 mg/kg) induced histopathological lesions of the testes, epididymis, and seminal vesicles, decrease in sperm motility, sperm cell concentration, plasma testosterone levels and significant increase in sperm head and tail abnormalities.
Danish: Hos voksne hanrotter forårsagede gentagen administration af propranolol ved høje dosisniveauer (≥7,5 mg/kg) histopatologiske læsioner af testiklerne, bitestiklerne og sædblærerne, nedgang i sædmotilitet, sædcellekoncentration, plasma testosteronniveauer og signifikant forøgelse af abnormiteter i sædcellens hoved og hale.
English: Clear, colourless to slightly yellow oral solution, with a fruity odour.
Danish: Oral opløsning Klar, farveløs til let gullig oral opløsning, med en frugtagtig lugt.
English: Skin and subcutaneous tissue disorders
Danish: Hud- og subkutant vævslidelser
English: 2 What you need to know before your child receives HEMANGIOL Do not give HEMANGIOL
Danish: 2 DET SKAL DU VIDE, FØR DIT BARN BEGYNDER AT TAGE HEMANGIOL Giv ikke HEMANGIOL
English: Propranolol crosses the blood-brain barrier and the placenta, and is distributed into breast milk.
Danish: Propranolol krydser hjernes blodbarriere og moderkagen, og distribueres ud i brystmælk.
English: Propranolol is metabolised in the liver and excreted by the kidneys.
Danish: Propranolol metaboliseres i leveren og udskilles af nyrerne.
English: In children who are at risk of anaphylaxis, the benefit risk of the medicinal product should be evaluated.
Danish: Hos børn med risiko for anafylaksi bør lægemidlets benefit/risk-forhold evalueres.
English: See section 2 under ‘HEMANGIOL contains sodium and propylene glycol' for further information.
Danish: Se yderligere oplysninger i afsnit 2 under 'HEMANGIOL indeholder natrium og propylenglycol'.
English: There is no clinical efficacy and safety data in the clinical studies carried out with HEMANGIOL to recommend its initiation in infants and children aged above 5 months.
Danish: I de kliniske studier, der er udført med HEMANGIOL, findes der ingen klinisk effektivitet eller sikkerhedsdata, som kan begrunde en anbefaling af initiering hos spædbørn og børn over 5 måneder.
English: Third and following weeks (3 mg/kg/day)
Danish: Tredje uge og efterfølgende uger (3 mg/kg/dag)
English: In the absence of data in children, propranolol is not recommended in case of renal or hepatic impairment (see section 4.2).
Danish: På grund af mangelende data hos børn, anbefales propranolol ikke i tilfælde af svækket lever- eller nyrefunktion (se pkt.
English: • is prone to low blood sugar level.
Danish: • er tilbøjelig til lavt blodsukkerniveau.
English: Dihydropyridines
Danish: Dihydropyridiner
English: Important warning signs of potential side effects such as low blood pressure, low heart rate, low blood sugar level, and bronchospasm (breathing difficulties) should be looked after following administration of HEMANGIOL.
Danish: Man skal være opmærksom på vigtige tegn på mulige bivirkninger såsom lavt blodtryk, lav hjertefrekvens, lavt blodsukkerniveau og bronchospasme (vejrtrækningsbesvær) efter at have givet HEMANGIOL.
English: Important signs to look after administration of HEMANGIOL Risk of hypotension and bradycardia (low heart rate)
Danish: Vigtige tegn at holde opsyn med efter administration af HEMANGIOL Risiko for lavt blodtryk og bradykardi (lav hjertefrekvens)
English: • Heart conduction or rhythm disorders (slow or uneven heart beats),
Danish: • Forstyrrelse af hjerteledning eller -rytme (langsom eller ujævn hjertefrekvens),
English: Propranolol prevents the response of endogenous catecholamines to correct hypoglycaemia.
Danish: Propranolol forhindrer respons fra endogene katekolaminer og dermed deres evne til at kompensere for hypoglykæmi.
English: Risks of bronchospasm
Danish: Risiko for bronchospasme
English: 7 MARKETING AUTHORISATION HOLDER
Danish: 7 INDEHAVER AF MARKEDSFØRINGSTILLADELSEN
English: HEMANGIOL should be administered directly into the child's mouth using the graduated oral syringe, calibrated in mg of propranolol base, supplied with the oral solution bottle (see instructions for use in section 3 of the patient information leaflet).
Danish: HEMANGIOL skal administreres direkte i barnets mund ved hjælp af den medfølgende orale sprøjte med måleangivelse, kalibreret i mg propranololbase (se anvisninger vedrørende brug under pkt.
English: In the event of lower respiratory tract infection associated with dyspnoea and wheezing, treatment should be temporarily discontinued.
Danish: I tilfælde af infektion i de nedre luftveje forbundet med åndenød og hiven efter vejret, bør behandlingen afbrydes midlertidigt.
English: HEMANGIOL is to be given during or right after a feed to avoid the risk of hypoglycaemia.
Danish: HEMANGIOL skal gives under eller umiddelbart efter et måltid for at undgå risikoen for hypoglykæmi.
English: Cardiovascular medicinal products
Danish: Kardiovaskulære lægemidler
English: Skip the missed dose, and do not give a double dose to make up for a forgotten dose.
Danish: Du må ikke give en dobbeltdosis som erstatning for en glemt dosis.
English: • The metabolism of propranolol is reduced by co-administration of quinidine, leading to a twothree-fold increased blood concentration and greater degrees of clinical beta-blockade.
Danish: • Metaboliseringen af propranolol reduceres af samtidig administration af quinidin, hvilket fører til en fordobling eller en tredobling af blodkoncentrationen og en større grad af klinisk betablokade.
English: • Bradycardia (abnormally low heart rate),
Danish: • Bradykardi (unormalt lav hjertefrekvens),
English: All beta-blocking agents can mask certain symptoms of hypoglycaemia: palpitations and tachycardia.
Danish: Alle betablokerende stoffer kan maskere visse symptomer på hypoglykæmi: Hjertebanken og takykardi.
English: • HEMANGIOL and the feed must be given by the same person in order to avoid the risk of hypoglycaemia.
Danish: • HEMANGIOL og måltider skal gives af den samme person, for at undgå risiko for hypoglykæmi.
English: What you need to know before your child receives HEMANGIOL 3.
Danish: Det skal du vide, før dit barn begynder at tage HEMANGIOL 3.
English: - For hypoglycaemia: minor symptoms like pallor, tiredness, sweating, shakiness, palpitations, anxiety, hunger, difficulty waking up; major symptoms like excessive sleeping, difficulty to get a response, poor feeding, temperature decrease, convulsions (fits), brief pauses in breathing, loss of consciousness
Danish: - For hypoglykæmi: Mindre betydelige symptomer såsom bleghed, træthed, transpiration, rystelser, hjertebanken, angst, sult, besvær med at vågne op; mere vigtige symptomer såsom overdreven søvn, vanskeligheder med at få til at reagere, lavt fødeindtag, temperaturfald, kramper (anfald), korte pauser i vejrtrækningen, tab af bevidsthed
English: • Bronchiolitis (inflammation of small bronchi with breathing difficulties and wheeze in the chest,
Danish: • Bronchiolitis (inflammation af små bronkier med vejrtrækningsbesvær og hiven efter vejret i brystet forbundet med hoste og feber),
English: Antihypertensives (ACE Inhibitors, angiotensin II-receptors antagonists, diuretics, alpha-blockers whatever the indication, centrally-acting antihypertensives, reserpine, etc) When combined with beta-blockers, medicinal products that decrease arterial pressure can cause or increase hypotension, notably orthostatic.
Danish: Antihypertensiva (ACE-hæmmere, angiotensin II-receptorantagonister diuretika, alfa-blokkere uanset indikation, centralt virkende antihypertensiva,reserpin og lignende) Når lægemidler, der sænker det arterielle blodtryk, kombineres med beta-blokkere, kan det forårsage yderligere hypotension, især ortostatisk.
English: Bradycardia -inducing calcium-channel blockers (diltiazem, verapamil, bepridil) Co-administration with propranolol can cause altered automaticity (excessive bradycardia, sinus arrest), sino-atrial and atrio-ventricular conduction disorders, and increased risk of ventricular arrhythmias (torsades de pointes) along with heart failure.
Danish: Bradykardi-fremkaldende calciumantagonister (diltiazem, verapamil, bepridil) Samtidig administration af propranolol kan medføre ændret automatik (overdreven bradykardi, sinus stop) sino-atrial og atrioventrikulære ledningsforstyrrelser og øget risiko for ventrikulære arytmier (torsades de pointes) samt hjertesvigt.
English: • a local haemodynamic effect (vasoconstriction which is a classical consequence of beta adrenergic blockade and a decrease of infantile haemangioma lesion perfusion);
Danish: • en lokal hæmodynamsik virkning (vasokonstriktion, som er en klassisk konsekvens af betaadrenergisk blokade og en reduktion af perfusionen af læsioner forbundet med infantil hæmangiom);
English: 10 rue Bouché Thomas ZAC Sud d'Orgemont 49000 ANGERS FRANCE
Danish: 10 rue Bouché Thomas ZAC Sud d'Orgemont 49000 ANGERS FRANKRIG
English: 6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Danish: 6 FARMACEUTISKE OPLYSNINGER 6.1 Hjælpestoffer
English: Replace the plastic cap on the bottle by turning it clock-wise (to the right).
Danish: Sæt plastiklåget på flasken og luk det ved at dreje mod uret (mod højre).
English: Isolated cases of symptomatic bradycardia and hypotension have been reported in literature.
Danish: I litteraturen er der blevet rapporteret om isolerede tilfælde med symptomatisk bradykardi og hypotension.
English: • Propafenone has negative inotropic and beta-blocking properties that can be additive to those of propranolol.
Danish: • Propafenon har negative inotropiske og betablokerende egenskaber, som kan have en forstærkende virkning på propranolols egenskaber.
English: Globally, the adverse reactions reported in the compassionate use program and in literature concerned hypoglycemia (and related event like hypoglycaemic seizure) and aggravated respiratory tract infections with respiratory distress.
Danish: Overordnet set omhandlede de indrapporterede bivirkninger fra programmet for anvendelse med særlig udleveringstilladelse, og i litteraturen, hypoglykæmi (og relateret hændelse som hypoglykæmisk krampe) og forværrede infektioner i åndedrætsorganerne med åndenød.
English: The bottle comes with a child-proof cap.
Danish: Flasken leveres med et børnesikret låg.
English: Beta stimulating agents may be used to counteract the beta-blockade.
Danish: Betastimulerende midler kan anvendes til at modvirke betablokaden.
English: 1 What HEMANGIOL is and what it is used for What HEMANGIOL is
Danish: 1 VIRKNING OG ANVENDELSE Hvad HEMANGIOL er
English: Uncommon side effects (may affect up to 1 in 100 people)
Danish: Ualmindelige bivirkninger (kan påvirke op til 1 ud af 100 personer)
English: Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate.
Danish: Både digitalis glycosid og betablokkere forlænger AV-overledningstiden og nedsætter hjertefrekvensen.
English: If necessary, the medicinal product may be diluted in a small quantity of baby-milk or age-adapted apple and/or orange fruit juice.
Danish: Medicinen kan om nødvendigt fortyndes med en lille mængde baby-mælk eller en passende æble- eller appelsin juice i forhold til barnets alder.
English: Remove the syringe
Danish: Tag sprøjten af
English: • Medicines for heart and blood vessels problems such as uneven heart beats, chest pain or angina,
Danish: • Medicin for hjerte/karproblemer, såsom ujævn hjertefrekvens, brystsmerter eller angina, højt blodtryk, hjertesvigt,
English: The effects generally totally reversed after treatment cessation.
Danish: Effekterne var generelt fuldstændig reversible efter behandlingsophør.
English: 120 mL solution, in a type III amber-glass bottle fitted with a low density polyethylene insert and a child resistant polypropylene screw cap, provided with a polypropylene oral syringe graduated in mg of propranolol base.
Danish: 120 ml opløsning i brune glasflasker (type III) udstyret med en LD-polyethylenindsats og et børnesikret skruelåg i polypropylen, leveret med en oral sprøjte i polypropylen med måleangivelse i mg propranololbase.
English: 10, rue Bouché Thomas ZAC d'Orgemont F-49000 Angers France
Danish: 10, rue Bouché Thomas ZAC d'Orgemont F-49000 Angers Frankrig
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Danish: • Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: Somnolence
Danish: Somnolens
English: Second week (2 mg/kg/day)
Danish: Anden uge (2 mg/kg/dag)
English: First week (1 mg/kg/day)
Danish: Første uge (1 mg/kg/dag)
English: • Infants prone to hypoglycaemia
Danish: • Børn med tilbøjelighed til hypoglykæmi
English: • Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with β-blockers such as propranolol.
Danish: • Amiodaron er et antiarytmika med negative kronotropiske egenskaber, som kan have en forstærkende virkning på egenskaberne set hos betablokkere, såsom propranolol.
English: Insert tip of the oral syringe into the upright bottle and push the plunger all the way down.
Danish: Indfør spidsen af den orale sprøjte i den opretstående flaske, og tryk stemplet helt i bund.
English: Propranolol passes through breast milk, mothers being treated with propranolol who breastfeed their infant should inform their health care professional.
Danish: Mødre, der behandles med propranolol og ammer deres barn, bør informere deres læge.
English: DO NOT GIVE HEMANGIOL TO YOUR CHILD UNTIL HE IS BEING CORRECTLY FED AGAIN.
Danish: GIV IKKE HEMANGIOL TIL DIT BARN, FØR HAN/HUN BLIVER KORREKT MADET IGEN.
English: Bronchospasm
Danish: Bronchospasme
English: Package leaflet: Information for the user HEMANGIOL 3.75 mg/mL oral solution propranolol
Danish: Indlægsseddel: Information til brugeren HEMANGIOL 3,75 mg/ml, oral opløsning propranolol
English: With the oral syringe in place, turn the bottle upside down.
Danish: Med den orale sprøjte på plads, vendes flasken på hovedet.
English: • has circulation problems which make the toes and fingers numb and pale.
Danish: • har kredsløbsproblemer, som gør fingre og tæer følelsesløse og blege.
English: Infants with hepatic or renal impairment
Danish: Børn med lever- eller nyresvækkelse
English: Hyperkaliemia cases have been reported in patients with large ulcerated hemangioma.
Danish: Der er rapporteret om tilfælde af hyperkaliæmi hos patienter med stort ulcereret hæmangiom.
English: PIERRE FABRE DERMATOLOGIE 45 Place Abel Gance 92100 BOULOGNE FRANCE
Danish: PIERRE FABRE DERMATOLOGIE 45 Place Abel Gance 92100 BOULOGNE FRANKRIG
English: Do not dismantle the syringe.
Danish: Skil ikke sprøjten ad.
English: • Life- or function-threatening haemangioma,
Danish: • Livs- eller funktionstruende hæmangiom,
English: If your child is not eating, develops another illness or is vomiting, it is recommended to skip the dose.
Danish: Hvis dit barn ikke spiser, udvikler anden sygdom eller kaster op, anbefales det at springe dosis over.
English: PHACE syndrome
Danish: PHACE-syndrom
English: • Vanilla flavour (contains propylene glycol)
Danish: • Vanillesmag (indeholder propylenglycol)
English: • Step 8.
Danish: • Trin 8.
English: They may depress myocardial contractility and vascular compensating response when administered with propranolol.
Danish: De kan svække myokardiekontraktilitet, når de administreres sammen med propranolol.
English: Turn bottle upright and remove the entire syringe from the bottle.
Danish: Vend flasken om til opretstående stilling og tag hele sprøjten af flasken.
English: • Minor: pallor, tiredness, sweating, shaking, palpitations, anxiety, hunger, difficulty waking up.
Danish: • Ubetydelige: bleghed, træthed, transpiration, rystelser, hjertebanken, angst, sult, besvær med at vågne.
English: Do not use a spoon or any other dispensing device.
Danish: Anvend ikke en ske eller andre doseringsanordninger.
English: Caution should be exercised when patients receiving a beta blocker are administered a dihydropyridine.
Danish: Der bør udvises forsigtighed, når patienter, der modtager betablokkere, samtidig får et kalciumkanalblokerende lægemiddel.
English: • Elevated level of potassium in the blood
Danish: • Højt kaliumniveau i blodet.
English: Agitation Nightmares Irritability
Danish: Søvnforstyrrelser Ophidselse Mareridt
English: Give HEMANGIOL to your child
Danish: Giv HEMANGIOL til dit barn
English: HEMANGIOL and the feed must be given by the same person in order to avoid the risk of hypoglycaemia.
Danish: HEMANGIOL og måltider skal gives af samme person for at undgå risiko for hypoglykæmi.
English: HEMANGIOL 3.75 mg/mL oral solution
Danish: HEMANGIOL 3,75 mg/ml, oral opløsning
English: Always give this medicine to your child exactly as your doctor or pharmacist has told you.
Danish: Brug altid dette lægemiddel nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: Other medicines and HEMANGIOL
Danish: Brug af anden medicin sammen med HEMANGIOL
English: • Low blood pressure,
Danish: • Lavt blodtryk,
English: Dose by intake Timing of intakes
Danish: Dosis pr. indgivelse
English: Hyperkalaemia has been reported in the literature in few patients with large ulcerated haemangioma (see section 4.4).
Danish: Der er rapporteret om hyperkaliæmi i litteraturen hos få patienter med stort ulcereret hæmangiom (se pkt.
English: Check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen eller på apoteket eller sundhedspersonalet, hvis der er noget, du er i tvivl om.
English: • Phaeochromocytoma
Danish: • Fæokromocytom
English: • Haemangioma with a risk of permanent scars or disfigurement.
Danish: • Hæmangiom med risiko for pernanente ar eller vansiring.
English: In this case, the need of stopping breast-feeding should be discussed.
Danish: Nødvendigheden af at afbryde amningen bør drøftes i sådanne tilfælde.
English: Neutropenia
Danish: Pirrelighed
English: Risk of hyperkaliemia
Danish: Risiko for hyperkaliæmi
English: • If your child is not eating or is vomiting it is recommended to skip the dose.
Danish: • Hvis dit barn ikke spiser eller kaster op, anbefales det at springe dosen over.
English: • Sodium saccharin
Danish: • Natriumsaccharinat
English: For children weighing more than 5 kg the dose may be mixed with a tablespoonful of milk or fruit juice (approximately 15 mL).
Danish: Hvis barnet vejer over 5 kg, kan du blande dosen med en spiseskefuld mælk eller frugtjuice (cirka 15 ml).
English: Risks of hypoglycaemia
Danish: Risiko for hypoglykæmi
English: Erythema Dermatitis diaper
Danish: Erytem Bledermatitis
English: Diarrhea Vomiting
Danish: Diarré Opkast
English: Tell the your doctor that he/she is taking HEMANGIOL.
Danish: Fortæl din læge, at dit barn får HEMANGIOL.
English: If you forget to give HEMANGIOL to your child
Danish: Hvis du har glemt at give dit barn HEMANGIOL
English: HEMANGIOL 3.75 mg/mL oral solution propranolol
Danish: HEMANGIOL 3,75 mg/ml, oral opløsning propranolol
English: • Constipation, abdominal pain,
Danish: • Forstoppelse, mavesmerter,
English: Please check with your doctor if you are not sure.
Danish: • har en lav hjertefrekvens for sin alder. Spørg venligst din læge, hvis du ikke er sikker.
English: If you stop giving HEMANGIOL to your child
Danish: Hvis du holder op med at give dit barn HEMANGIOL
English: Fertility
Danish: Fertilitet:
English: For children weighing up to 5 kg you may mix the dose with one teaspoonful of milk (approximately 5 mL).
Danish: Hvis barnet vejer under 5 kg, kan du blande dosen med en teskefuld mælk (cirka 5 ml).
English: The posology is expressed in propranolol base.
Danish: Doseringen angives i mg propranolol base.
English: Bradycardia is defined below the following limits:
Danish: Bradykardi defineres som en hjertefrekvens under følgende grænser: Alder
English: Store the bottle and oral syringe in the outer carton between each use.
Danish: Opbevar flasken og den orale sprøjte i yderemballagen mellem hver brug.
English: Do not mix the medicine with a full bottle of milk or juice.
Danish: Du må ikke blande medicinen i en helt fyldt sutteflaske.
English: 'phaeochromocytoma'.
Danish: Dette kaldes phæochromocytom.
English: Insert the syringe
Danish: Indfør sprøjten
English: Age (35-90 days / 91150 days), gender and haemangioma location (head / body) subgroups did not identify differences in response to propranolol.
Danish: Der blev ikke identificeret forskelle i responsen over for propranolol i undergrupper for alder (35-90 dage / 91-150 dage), køn og hæmangiomplacering (hoved / krop).
English: • Step 9.
Danish: • Trin 9.
English: How to give HEMANGIOL to your child 4.
Danish: Sådan skal du give HEMANGIOL til dit barn 4.
English: • Circulation problems which make the toes and fingers numb and pale
Danish: • Kredsløbsproblemer som gør fingre og tæer følelsesløse og blege,
English: Use with oral syringe graduated in mg of propranolol included in the package.
Danish: Anvendes med den medfølgende orale sprøjte med måleangivelse i mg propanolol.
English: 1 ml of solution contains 4.28 mg of propranolol hydrochloride equivalent to 3.75 mg of propranolol base.
Danish: 1 ml af opløsningen indeholder 4,28 mg propranololhydrochlorid svarende til 3,75 mg propranololbase.
English: Each ml contains 4.28 mg of propranolol hydrochloride equivalent to 3.75 mg of propranolol.
Danish: Hver ml indeholder 4,28 mg propranololhydrochlorid ækvivalent med 3,75 ml propranolol.
English: Worsening of disease has been reported with beta-blockers in patients suffering from psoriasis.
Danish: Hos patienter der lider af psoriasis, er der rapporteret om forværring af sygdommen med betablokkere.
English: • Step 7.
Danish: • Trin 7.
English: If the child is not eating or is vomiting it is recommended to skip the dose.
Danish: Hvis barnet ikke spiser eller kaster op, anbefales det at springe dosisen over.
English: • Decreased blood pressure.
Danish: • Nedsat blodtryk,
English: Respiratory disorders
Danish: Åndedrætslidelser
English: Liver or kidney failure
Danish: Lever- eller nyresvigt
English: • Hemangiol is for oral use.
Danish: • Hemangiol skal gives via munden.
English: • Strawberry flavour (contains propylene glycol)
Danish: • Jordbærsmag (indeholder propylenglycol)
English: In the absence of clinical efficacy and safety data, HEMANGIOL should not be used in infants aged below 5 weeks.
Danish: HEMANGIOL er ikke undersøgt hos børn under 5 uger og bør derfor ikke anvendes til denne patientpopulation.
English: • Step 2.
Danish: • Trin 2.
English: Psychiatric disorders
Danish: Psykiatriske lidelser
English: • Medicines used for anaesthesia.
Danish: • Medicin til narkose.
English: Batch
Danish: Batch {Nummer}
English: 1 ml of solution contains 4.28 mg of propranolol hydrochloride equivent to 3.75 mg of propranolol.
Danish: 1 ml af opløsningen indeholder 4,28 mg propranololhydrochlorid ækvivalent med 3,75 mg propranolol.
English: Nervous system disorders
Danish: Nervesystem lidelser
English: • Major: excessive sleeping, difficulty responding, poor feeding, decrease in body temperature,
Danish: • Betydelige: overdreven søvn, svær at få til at reagere, lavt fødeindtag, fald i kropstemperatur, kramper (anfald), korte pauser i vejrtrækningen, tab af bevidsthed.
English: Breast-feeding Breastfeeding mothers: see section 4.4 and section 4.5.
Danish: Amning: Ammende mødre: se pkt.
English: Enzyme inducers
Danish: Enzymindukatorer
English: • Step 4.
Danish: • Trin 4.
English: Store the bottle and the oral syringe in the outer carton between each use.
Danish: Opbevar flasken og den orale sprøjte i æsken mellem hver brug.
English: Metalloproteinase 9);
Danish: 3 i indlægssedlen).
English: • Step 3.
Danish: • Trin 3.
English: Antiarrhythmics
Danish: Antiarytmika
English: 1 ml of solution contains
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: 1 ml opløsning indeholder
English: The carton contains the following items that you will need to administer the medicine: - The glass bottle containing 120 mL propranolol oral solution - The oral syringe graduated in mg provided with this medicine Remove the bottle and oral syringe from the box and remove the syringe from the plastic bag.
Danish: − Oral sprøjte med måleangivelse i mg med dette lægemiddel Tag flasken og den orale sprøjte ud af æsken, og tag sprøjten ud af plastikindpakningen.