FrancophonIA/ELRC3.0 huggingface dataset:
English: LS mean [95% CI]: 1.86 [-0.66, 4.39] c
Danish: LS-middelværdi [95% CI]: 1,86 [-0,66; 4,39] c
English: In addition, the pharmacokinetics of weight-based doses of levofloxacin administered by inhalation once daily for 14 days in paediatric patients with CF (≥ 6 to < 12 years old, n = 14 and ≥ 12 to < 17 years old, n = 13) were evaluated in Study 206.
Danish: Endvidere er farmakokinetikken for vægtbaserede doser af levofloxacin administreret ved inhalation en gang dagligt i 14 dage til pædiatriske patienter med CF (≥ 6 til < 12 år, n = 14 og ≥ 12 til < 17 år, n = 13) blevet evalueret i studie 206.
English: Quinsair 240 mg BID N = 189
Danish: Quinsair 240 mg to gange dagligt N = 189
English: - Liver problems.
Danish: - Leverproblemer.
English: Fluoroquinolones have been shown to cause arthropathy in weight-bearing joints of immature animals.
Danish: Fluorquinoloner har vist sig at forårsage artropati i vægtbærende led hos umodne dyr.
English: High levofloxacin concentrations were observed in sputum following Quinsair 240 mg twice daily dosing in patients with CF.
Danish: Der blev observeret høje koncentrationer af levofloxacin i spyt efter Quinsair 240 mg to gange dagligt hos patienter med CF.
English: b LS Mean (SE).
Danish: b LS-middelværdi (SE).
English: All patients had also received a minimum of 3 courses of inhaled anti-pseudomonal antimicrobial therapy in the 12 months (Study 204) or 18 months (Study 207) prior to entry into the study, but none in the 28 days immediately preceding study entry.
Danish: Alle patienter havde endvidere gennemgået mindst 3 forløb med inhaleret antipseudomonal antimikrobiel behandling inden for 12 måneder (studie 204) eller 18 måneder (studie 207) forud for inklusion i studiet, men ingen behandling inden for 28 dage umiddelbart før forsøgsinklusion.
English: Adult and adolescent (≥ 12 to < 18 years old and weighing ≥ 30 kg) patients who had a FEV1 percent predicted between 25% and 85% were enrolled.
Danish: Voksne og unge (≥ 12 til < 18 år og med en vægt på ≥ 30 kg) patienter, der havde en forventet FEV1-procent på mellem 25% og 85%, blev inkluderet.
English: Patients under treatment with levofloxacin should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop in order to prevent the development of potentially irreversible condition (see section 4.8).
Danish: Patienter i behandling med levofloxacin skal instrueres i at kontakte deres læge, før de fortsætter behandlingen, hvis de udvikler symptomer på neuropati, såsom smerter, en brændende eller prikkende fornemmelse, snurren, følelsesløshed eller svaghed, for at forebygge udvikling af en potentielt irreversibel tilstand (se pkt.
English: Multiple dose administration of Quinsair 240 mg twice daily by inhalation results in levofloxacin systemic exposure approximately 50% lower than that observed following systemic administration of comparable doses (see Table 3).
Danish: Flerdosisadministration af Quinsair 240 mg to gange dagligt ved hjælp af inhalation resulterede i en systemisk eksponering for levofloxacin, der var ca. 50% lavere, end der observeredes efter systemisk administration af sammenlignelige doser (se tabel 3).
English: If this happens, stop using Quinsair and contact your doctor immediately.
Danish: Hvis det sker, skal du straks holde op med at bruge Quinsair og kontakte lægen.
English: - The other ingredients are magnesium chloride hexahydrate and water for injections.
Danish: - Øvrige indholdsstoffer: magnesiumchloridhexahydrat og vand til injektioner.
English: LS mean [95% CI]:
Danish: LS-middelværdi [95% CI]:
English: Airway clearance techniques;
Danish: Teknikker til rensning af luftvejene,
English: Theophylline, fenbufen or similar non-steroidal anti-inflammatory drugs No pharmacokinetic interactions of levofloxacin were found with theophylline in a clinical study.
Danish: Theophyllin, fenbufen eller tilsvarende ikke-steroide antiinflammatoriske lægemidler Der er i et klinisk studie ikke påvist farmakokinetiske interaktioner mellem levofloxacin og theophyllin.
English: - Do not try to inhale Quinsair using any other type of nebuliser handset.
Danish: - Forsøg ikke at inhalere Quinsair ved hjælp af en anden type nebulisatorhåndsæt.
English: Cough/productive cough,
Danish: Hoste/produktiv hoste, Dyspnø,
English: Ear and labyrinth disorders1
Danish: Øre og labyrint1
English: Quinsair must not be used whilst pregnant or breast-feeding.
Danish: Quinsair må ikke anvendes under graviditet, eller hvis du ammer.
English: The adverse reactions with at least a reasonable possibility of a causal relationship with Quinsair are presented according to the MedDRA System Organ Classification.
Danish: Bivirkninger med i det mindste en rimelig mulighed for en kausal forbindelse med Quinsair er angivet i henhold til MedDRAs systemorganklassifikation.
English: If a dose is missed, it should be taken as soon as the patient remembers providing that at least an 8 hour interval is allowed before inhaling the next dose.
Danish: Hvis patienten har glemt en dosis, skal den tages, så snart patienten opdager det, forudsat at der mindst er et tidsinterval på 8 timer til inhalation af den næste dosis.
English: Vomiting, Abdominal pain*, Diarrhoea* Constipation*
Danish: Opkastning, Abdominalsmerter*, Diarré*
English: In addition, 14 children with CF (≥ 6 to < 12 years old) and 13 adolescents with CF (≥ 12 to < 17 years old) received Quinsair 180 mg or 240 mg once daily for 14 days.
Danish: Endvidere har 14 børn med CF (≥ 6 til < 12 år) og 13 unge med CF (≥ 12 til < 17 år) fået Quinsair 180 mg eller 240 mg en gang dagligt i 14 dage.
English: The adverse reactions with at least a reasonable possibility of a causal relationship with levofloxacin are presented according to the MedDRA System Organ Classification.
Danish: Bivirkninger med i det mindste en rimelig mulighed for en kausal forbindelse med levofloxacin er angivet i henhold til MedDRAs systemorganklassifikation.
English: Therefore, fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients with positive family history of aneurysm disease, or in patients diagnosed with pre-existing aortic aneurysm and/or aortic dissection, or in presence of other risk factors or conditions predisposing for aortic aneurysm and dissection (e.g. Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet's disease, hypertension, known atherosclerosis).
Danish: Derfor bør fluorquinoloner kun anvendes efter en grundig vurdering af benefit/risk-forholdet og efter overvejelse af andre terapeutiske muligheder hos patienter med en familieanamnese med aneurismer og hos patienter med tidligere diagnosticeret aortaaneurisme og/eller aortadissektion eller ved tilstedeværelse af andre risikofaktorer eller tilstande, der prædisponerer for aortaaneurisme ogdissektion (f.eks. Marfans syndrom, vaskulær Ehlers-Danlos syndrom, Takayasus arteritis, kæmpecelle arteritis, Behcets sygdom, hypertension eller kendt aterosklerose).
English: Levofloxacin caused no impairment of fertility or reproductive performance in rats (see section 5.3).
Danish: Levofloxacin forårsagede ingen nedsættelse af fertilitet eller reproduktionsevne hos rotter (se pkt.
English: However, dose adjustments were not employed in clinical studies of Quinsair which allowed for the inclusion of patients with mild to moderate renal impairment (estimated creatinine clearance ≥ 20 ml/min using the Cockcroft-Gault formula in adult patients and ≥ 20 ml/min/1.73 m2 using the Bedside Schwartz formula in patients < 18 years old).
Danish: Der blev dog ikke foretaget dosisjusteringer i kliniske studier med Quinsair, der tillod inklusion af patienter med let til moderat nedsat nyrefunktion (estimeret kreatininclearance ≥ 20 ml/minut ved anvendelse Cockcroft-Gault-formlen hos voksne patienter og ≥ 20 ml/minut/1,73 m2 ved anvendelse af Bedside Schwartz-formlen hos patienter
English: Non-clinical studies conducted with levofloxacin using the inhalation route revealed no special hazard for humans based on conventional studies of safety pharmacology (respiratory), single dose toxicity and repeated dose toxicity.
Danish: Prækliniske studier udført med levofloxacin administreret ved inhalation viste ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi (respiratorisk), toksicitet efter en enkelt dosis og toksicitet efter gentagne doser.
English: The proportion of patients who received Quinsair throughout Study 209 Core and Extension Phases (with a highest levofloxacin MIC P. aeruginosa isolate exceeding 1 µg/ml) was similar at the end of treatment during Cycles 1 and 3 in the Core Phase (76.6% to 83.3%) and at the end of treatment during Cycles 4 to 6 in the Extension Phase (77.8% to 87.5%).
Danish: Andelen af patienter, der fik Quinsair gennem studie 209's kerne- og forlængelsesfaser (med et højeste levofloxacin-MIC-P. aeruginosa-isolat, der oversteg 1 µg/ml), var omtrent den samme ved behandlingsafslutning i cyklus 1 og 3 i kernefasen (76,6% til 83,3%) og ved behandlingsafslutning i cyklus 4 til 6 i forlængelsesfasen (77,8% til 87,5%).
English: The mean apparent volume of distribution of levofloxacin in serum is approximately 250 L following inhalation of Quinsair 240 mg twice daily.
Danish: Det gennemsnitlige tilsyneladende fordelingsvolumen af levofloxacin i serum er ca. 250 l efter inhalation af Quinsair 240 mg to gange dagligt.
English: 56 (14 sachets of 4) ampoules.
Danish: 56 (14 breve med hver 4) ampuller.
English: Table 1: FEV1 Percent predicted relative change from baseline to Day 28 in placebo-controlled efficacy and safety studies of Quinsair in patients with CF
Danish: Tabel 1: Relativ ændring i forventet FEV1-procent fra baseline til dag 28 i placebokontrollerede studier af virkning og sikkerhed af Quinsair hos patienter med CF Understøttende studier Studie 207 (ITT)
English: • Breast-feeding women.
Danish: • Ammende kvinder.
English: Anaphylactic shock, Anaphylactoid shock
Danish: Angioødem Anafylaktisk shock, Anafylaktoidt shock
English: In Studies 204, 207 and 209, the relative change in FEV1 percent predicted from baseline to the end of treatment in Cycle 1 was of similar magnitude in the 51 adolescents with CF (≥ 12 to < 18 years old and weighing ≥ 30 kg) receiving Quinsair 240 mg twice daily to that in adults.
Danish: I studierne 204, 207 og 209 var den relative ændring i forventet FEV1-procent fra baseline til behandlingsafslutning i cyklus 1 af samme størrelsesorden hos de 51 unge med CF (≥ 12 til < 18 år og med en vægt på ≥ 30 kg), der fik Quinsair 240 mg to gange dagligt, som hos voksne.
English: What Quinsair contains - The active substance is levofloxacin.
Danish: Quinsair indeholder: - Aktivt stof: levofloxacin.
English: TIS 300 mg BID N = 93
Danish: TIS 300 mg to gange dagligt N = 93
English: For the subgroup of patients who received TIS during the Core Phase and switched to Quinsair in the Extension Phase, the improvement in FEV1 percent predicted was more marked on Quinsair than on TIS (LS Mean change in FEV1 percent predicted on TIS ranged between 0.97% to 3.60% across Cycles 1 to 3 and between 4.00% to 6.91% across Cycles 4 to 6 on Quinsair).
Danish: For den delgruppe af patienter, der fik TIS i løbet af kernefasen og skiftede til Quinsair i forlængelsesfasen, var forbedringen i forventet FEV1-procent mere markant på Quinsair end på TIS (ændring af LS-middelværdi for forventet FEV1-procent på TIS lå i intervallet mellem 0,97% og 3,60% over cyklus 1 til 3 og mellem 4,00% og 6,91% over cyklus 4 til 6 på Quinsair).
English: Nervous system disorders1
Danish: Nervesystemet1
English: c Non-inferiority was tested using a pre-specified, fixed non-inferiority margin of 4% at Day 28 of Cycle 1. d Estimates were obtained from a Cox proportional hazards regression model.
Danish: c Non-inferioritet blev testet ved anvendelse af en præspecificeret, fast non-inferioritetsmargin på 4% på dag 28
English: Tabulated list of additional adverse reactions reported following systemic administration of levofloxacin
Danish: Skematisk oversigt over yderligere bivirkninger, der er rapporteret efter systemisk administration af levofloxacin
English: - Do not use Quinsair if you notice that the sealed foil sachet or ampoules have been tampered with.
Danish: - Brug ikke Quinsair, hvis du bemærker, at der er pillet ved det forseglede foliebrev eller ampullerne.
English: (See sections 4.2 and 5.3.)
Danish: 4.2 og 5.3).
English: Patients predisposed to seizures
Danish: Patienter, der er prædisponeret for krampeanfald
English: CI = Confidence interval; FEV1 = forced expiratory volume in 1 second; ITT = intent-to-treat (all patients randomised); P = P-value; SD = standard deviation; SE = standard error; TIS = tobramycin inhalation solution.
Danish: CI = konfidensinterval, FEV1 = forceret ekspiratorisk volumen i 1 sekund, ITT = intent-to-treat (alle randomiserede patienter), P = P-værdi, SD = standardafvigelse, SE = standardfejl, TIS = tobramycininhalationsopløsning.
English: Coagulation tests, therefore, should be monitored in patients treated with vitamin K antagonists (see section 4.4).
Danish: Koagulationstests bør derfor overvåges hos patienter, der behandles med vitamin Kantagonister (se pkt.
English: Tachycardia*
Danish: Takykardi*
English: If you experience breathing difficulties when you use Quinsair what additional medicine may your doctor prescribe for you?
Danish: Hvis du oplever vejrtrækningsproblemer, mens du bruger Quinsair, kan din læge eventuelt ordinere ekstra medicin til dig?
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of nebuliser solution contains levofloxacin hemihydrate equivalent to 100 mg of levofloxacin.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver ml inhalationsvæske til nebulisator, opløsning indeholder levofloxacinhemihydrat svarende til 100 mg levofloxacin.
English: Levofloxacin is not recommended in patients with a known history of myasthenia gravis.
Danish: Levofloxacin bør ikke anvendes til patienter med kendt myasthenia gravis i anamnesen.
English: What you need to know before you use Quinsair
Danish: Det skal du vide, før du begynder at bruge Quinsair
English: Convulsion, Paraesthesia
Danish: Konvulsion, Paræstesi
English: Quinsair is used to treat lung infections caused by Pseudomonas aeruginosa in adults with cystic fibrosis.
Danish: Quinsair anvendes til at behandle lungeinfektioner, der skyldes Pseudomonas aeruginosa, hos voksne med cystisk fibrose.
English: N = 93 90.5 days
Danish: N = 93 90,5 dage
English: Quinsair contains an antibiotic medicine called levofloxacin.
Danish: Quinsair indeholder et antibiotisk lægemiddel, der kaldes levofloxacin.
English: N = 93 110 days
Danish: N = 93 110 dage
English: 2) Hold the handset level, press and hold the on/off button on the controller for a few seconds.
Danish: 2) Hold håndsættet vandret, tryk på afbryderknappen på styreenheden, og hold den nede i nogle få sekunder.
English: Do not put other medicinal products into the Zirela Nebuliser Handset.
Danish: Undlad at komme andre lægemidler i Zirela-nebulisatorhåndsættet.
English: General disorders and administration site conditions1
Danish: Almene symptomer og reaktioner på administrationsstedet1
English: Squeeze all of the contents of one ampoule into the medicine reservoir of the Zirela Nebuliser Handset.
Danish: Tryk alt indholdet fra én ampul ud i medicinbeholderen i Zirela-nebulisatorhåndsættet.
English: Pharmacokinetic studies with Quinsair in patients with hepatic impairment have not been conducted.
Danish: Der er ikke udført farmakokinetiske studier med Quinsair til patienter med nedsat leverfunktion.
English: The safety and efficacy of Quinsair in children aged ˂ 18 years old have not yet been established.
Danish: Quinsairs sikkerhed og virkning hos børn i alderen < 18 år er endnu ikke klarlagt.
English: The use of levofloxacin should be avoided in patients who have experienced serious adverse reactions in the past when using quinolone or fluoroquinolone containing products (see section 4.8).
Danish: Anvendelsen af levofloxacin bør undgås hos patienter, der tidligere har oplevet alvorlige bivirkninger, når de brugte præparater, der indeholdt quinolon eller fluorquinolon (se pkt.
English: Cases of severe bullous skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported with systemic administration of levofloxacin (see section 4.8).
Danish: Tilfælde af svære bulløse hudreaktioner, såsom Stevens-Johnsons syndrom eller toksisk epidermal nekrolyse, er blevet rapporteret ved systemisk administration af levofloxacin (se pkt.
English: Quinsair is administered by inhalation over a 5 minute period using a Quinsair specific Zirela Nebuliser Handset and Zirela Aerosol Head connected to an eBase Controller or an eFlow rapid Control Unit (see section 4.2).
Danish: Quinsair administreres ved hjælp af inhalation over et tidsrum på 5 minutter ved anvendelse af et Quinsair-specifikt Zirela-nebulisatorhåndsæt og Zirela-aerosolhoved, der er forbundet til en eBasestyreenhed eller en eFlow rapid-styreenhed (se pkt.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LOW DENSITY POLYETHYLENE AMPOULE
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER AMPUL AF LAVDENSITETSPOLYETHYLEN
English: CI = Confidence interval; FEV1 = forced expiratory volume in 1 second; ITT = intent to treat (all patients randomised); P = P value; SD = standard deviation; SE = standard error; ANCOVA = analysis of covariance.
Danish: CI = konfidensinterval, FEV1 = forceret ekspiratorisk volumen i 1 sekund, ITT = intent-to-treat (alle randomiserede patienter), P = P-værdi, SD = standardafvigelse, SE = standardfejl, ANCOVA = analyse af kovarians.
English: Once opened, use immediately.
Danish: Skal bruges straks efter åbning.
English: • History of tendon disorders related to fluoroquinolone administration.
Danish: • Seneforstyrrelser, der er forbundet med administration af fluorquinolon, i anamnesen.
English: Disconnect the controller and dismantle the Zirela Nebuliser Handset for cleaning and disinfection.
Danish: Afkobl styreenheden, og afmontér Zirela-nebulisatorhåndsættet til rengøring og desinfektion.
English: The pharmacokinetics of levofloxacin administered by inhalation have not been studied in the elderly.
Danish: Farmakokinetikken for levofloxacin administreret ved hjælp af inhalation er ikke blevet undersøgt hos ældre.
English: Very rare cases of prolonged (continuing months or years), disabling and potentially irreversible serious adverse drug reactions affecting different, sometimes multiple, body systems (musculoskeletal, nervous, psychiatric and senses) have been reported in patients receiving quinolones and fluoroquinolones irrespective of their age and pre-existing risk factors.
Danish: Meget sjældne tilfælde af langvarige (fortsætter i måneder eller år), invaliderende og potentielt irreversible alvorlige bivirkninger, der påvirker forskellige, nogle gange flere kropssystemer (det muskuloskeletale system, nervesystemet, psyken og sanseorganer) er blevet rapporteret hos patienter, der fik quinoloner og fluorquinoloner, uanset deres alder og præeksisterende risikofaktorer.
English: if you have a family history of aortic aneurysm or aortic dissection or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, or vascular EhlersDanlos syndrome, or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet's disease, high blood pressure, or known atherosclerosis).
Danish: hvis der i din familie tidligere har været et tilfælde af aortaaneurisme eller aortadissektion eller andre risikofaktorer eller prædisponerende sygdomme (f.eks. bindevævssygdom som Marfans syndrom eller vaskulær Ehlers-Danlos syndrom eller karsygdomme som f.eks. Takayasu arteritis (blodårebetændelse), kæmpecelle arteritis, Behcets sygdom, for højt blodtryk eller kendt aterosklerose (åreforkalkning)).
English: Doses do not need to be adjusted in patients with mild to moderate renal impairment (estimated creatinine clearance ≥ 20 ml/min using the Cockcroft-Gault formula).
Danish: Der er ikke behov for dosisjustering hos patienter med let til moderat nedsat nyrefunktion (estimeret kreatininclearance ≥ 20 ml/minut ved anvendelse af Cockcroft-Gault-formlen).
English: Visual disturbance*
Danish: Synsforstyrrelse*
English: Quinsair should be taken by inhalation using a Zirela Nebuliser Handset (including a Zirela Aerosol Head).
Danish: Quinsair skal tages ved inhalation ved anvendelse af et Zirela-nebulisatorhåndsæt (der inkluderer et Zirela-aerosolhoved).
English: Bronchodilators
Danish: Bronkodilatorer
English: Blood alkaline phosphatase increased*, Electrocardiogram QT prolonged*, Eosinophil count increased*, Platelet count decreased*
Danish: Elektrokardiogram med QTforlængelse*, Forhøjet eosinofilantal*, Reduceret trombocytantal*
English: Very common: may affect more than 1 in 10 people - Cough - Abnormal sense of taste - Tiredness, weakness and lower tolerance to exercise - Loss of appetite and weight loss - Shortness of breath - Changes in the amount and thickness of mucus/phlegm - Coughing up blood - Decreased amount of air that can be breathed out in one second (decreased FEV1 test)
Danish: Meget almindelige: opstår hos mere end 1 bruger ud af 10 - Hoste - Unormal smagssans - Træthed, svaghed og lavere tolerance over for anstrengelse - Tab af appetit og vægttab - Stakåndethed - Ændringer i mængden og tykkelsen af slim - Ophostning af blod - Mindre mængde luft, der kan udåndes på ét sekund (nedsat FEV1-test)
English: Other medicines and Quinsair
Danish: Brug af anden medicin sammen med Quinsair
English: - Photosensitivity
Danish: - Lysfølsomhed
English: If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately (see sections 4.7 and 4.8).
Danish: Hvis synet bliver nedsat, eller patienten oplever andre virkninger på øjenene, skal en øjenspecialist straks konsulteres (se pkt.
English: 5) Breathe normally (inhale and exhale) through the mouthpiece.
Danish: 5) Træk vejret normalt (ånd ind og ud) gennem mundstykket.
English: N = 189 141 days
Danish: N = 189 141 dage
English: Retching, Dyspepsia*, Flatulence*
Danish: Kløgning, Dyspepsi*, Flatulens*
English: - Nerve damage
Danish: - Nervebeskadigelse
English: Close the medicine reservoir by aligning the tabs of the medicine cap with the slots of the reservoir.
Danish: Luk medicinbeholderen ved at rette tappene på medicinlåget ind i forhold til rillerne på beholderen.
English: In case of sudden abdominal, chest or back pain, patients should be advised to immediately consult a physician in an emergency department.
Danish: I tilfælde af pludselige smerter i maven, brystet eller ryggen bør patienterne rådes til at tage på skadestuen øjeblikkeligt.
English: Quinolone antibiotics, including Quinsair, may cause seizures or convulsions (fits).
Danish: Quinolon-antibiotika, herunder Quinsair, kan forårsage krampeanfald.
English: (Note: In Study 204, an additional 38 patients were randomised to Quinsair 120 mg once daily (≥ 18 years, n = 35; ≥ 16 to < 18 years old, n = 3) and an additional 37patients were randomised to Quinsair 240 mg once daily (≥ 18 years, n = 34; ≥ 16 to < 18 years old, n = 3).)
Danish: (Bemærk: I studie 204 blev yderligere 38 patienter randomiseret til Quinsair 120 mg en gang dagligt (≥ 18 år, n = 35 og ≥ 16 til < 18 år, n = 3), og yderligere 37 patienter blev randomiseret til Quinsair 240 mg en gang daglig (≥ 18 år, n = 34 og ≥ 16 til < 18 år, n = 3).
English: The safety and efficacy of Quinsair in children aged ˂ 18 years old have not yet been established (see section 4.2).
Danish: Quinsairs sikkerhed og virkning hos børn i alderen < 18 år er ikke klarlagt (se pkt.
English: LIST OF EXCIPIENTS magnesium chloride hexahydrate and water for injections.
Danish: LISTE OVER HJÆLPESTOFFER Magnesiumchloridhexahydrat og vand til injektioner.