FrancophonIA/ELRC3.0 huggingface dataset:
English: 3.56 micrometres (1.51 geometric standard deviation); drug delivery rate: 24.86 mg/minute (4.05 standard deviation, SD) and total drug delivered: 236.1 mg (7.1 SD).
Danish: In vitro-undersøgelser ved anvendelse af Zirela-nebulisatorsystemet med Quinsair har vist følgende lægemiddelfremføringsegenskaber: median aerodynamisk massediameter (dråbestørrelsesfordeling): 3,56 mikrometer (1,51 geometrisk standardafvigelse), lægemiddelfremføringshastighed: 24,86 mg/minut (4,05 standardafvigelse, SD) og total mængde fremført lægemiddel: 236,1 mg (7,1 SD).
English: Quinsair should only be used with the Zirela Nebuliser Handset (including a Zirela Aerosol Head) provided in the pack connected to an eBase Controller or an eFlow rapid Control Unit (see section 6.6).
Danish: Quinsair må kun anvendes med Zirela-nebulisatorhåndsættet (der inkluderer et Zirela-aerosolhoved), som følger med i pakningen, forbundet til en eBase-styreenhed eller en eFlow rapid-styreenhed (se pkt.
English: Uncommon: may affect up to 1 in 100 people - Feeling confused or nervous - Shaking - Sensation of dizziness, spinning or falling over (vertigo) - Excessive sweating
Danish: Ikke almindelige: opstår hos op til 1 bruger ud af 100 - Følelse af forvirring eller nervøsitet - Rysten - Følelse af svimmelhed, at tingene kører rundt eller følelse af at falde (vertigo) - Kraftig svedning
English: In clinical trials, 51 adolescents with CF (≥ 12 to < 18 years old) received Quinsair 240 mg twice daily and 6 adolescents with CF received Quinsair 120 mg (n = 3) or 240 mg (n = 3) once daily.
Danish: 51 unge med CF (≥ 12 til < 18 år) har i kliniske studier fået Quinsair 240 mg to gange dagligt, og 6 unge med CF har fået Quinsair 120 mg (n = 3) eller 240 mg (n = 3) en gang dagligt.
English: The following side effects have also been reported after taking tablets or an intravenous infusion containing levofloxacin, so they might possibly occur after using Quinsair:
Danish: Følgende bivirkninger er endvidere blevet rapporteret efter indtagelse af tabletter eller en intravenøs infusion, der indeholder levofloxacin.
English: Quinsair is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis (CF, see section 5.1).
Danish: Quinsair er indiceret til behandling af kroniske lungeinfektioner, der skyldes Pseudomonas aeruginosa, hos voksne patienter med cystisk fibrose (CF, se pkt.
English: Erythema multiforme, Photosensitivity reaction,
Danish: Erythema multiforme, Lysfølsomhedsreaktion, Leukocytoklastisk vasculitis,
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON BOX CONTAINING INNER CARTON BOX CONTAINING 56 (14 SACHETS OF 4) AMPOULES PLUS ONE “ZIRELA” NEBULISER HANDSET
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE PAPÆSKE, DER INDEHOLER INDRE PAPÆSKE, DER INDEHOLDER 56 (14 BREVE MED HVER 4) AMPULLER PLUS ÉT “ZIRELA”-NEBULISATORHÅNDSÆT
English: Each ampoule contains 240 mg of levofloxacin,
Danish: Hver ampul indeholder 240 mg levofloxacin,
English: N = 189 131 days
Danish: N = 189 131 dage
English: A total of 189 patients were randomised to Quinsair 240 mg twice daily (≥ 18 years, n = 170; ≥ 12 to < 18 years old, n = 19) and 93 were randomised to TIS (≥ 18 years, n = 84; ≥ 12 to < 18 years old, n = 9).
Danish: Ialt 189 patienter blev randomiseret til Quinsair 240 mg to gange dagligt (≥ 18 år, n = 170 og ≥ 12 til < 18 år, n = 19), og 93 blev randomiseret til TIS (≥ 18 år, n = 84 og ≥ 12 til < 18 år, n = 9).
English: Each ampoule contains 240 mg of levofloxacin.
Danish: Hver ampul indeholder 240 mg levofloxacin.
English: Sealed foil laminate sachet containing 4 ampoules.
Danish: Forseglet folielaminatbrev, der indeholder 4 ampuller.
English: A total of 259 patients were randomised to Quinsair 240 mg twice daily for 28 days (≥ 18 years, n = 226; ≥ 12 to < 18 years old, n = 33) and 147 were randomised to placebo (≥ 18 years, n = 127; ≥ 12 to < 18 years old, n = 20).
Danish: Ialt 259 patienter blev randomiseret til Quinsair 240 mg to gange dagligt i 28 dage (≥ 18 år, n = 226 og ≥ 12 til < 18 år, n = 33), og 147 blev randomiseret til placebo (≥ 18 år, n = 127 og ≥ 12 til < 18 år, n = 20).
English: Cyclical therapy may be continued for as long as the physician considers that the patient is obtaining clinical benefit.
Danish: Behandlingscyklusserne kan fortsættes, så længe lægen vurderer, at patienten har klinisk fordel af det. Doserne skal inhaleres med et interval så tæt som muligt på 12 timer.
English: Rare: may affect up to 1 in 1,000 people - Hallucinations and/or feeling paranoid - Feeling agitated - Unusual dreams or nightmares - Convulsions (fits) - Tingling sensation (pins and needles) and/or numbness - Palpitations - Low blood pressure - Muscle weakness
Danish: Sjældne: opstår hos op til 1 bruger ud af 1.000 - Hallucinationer og/eller paranoia - Følelse af uro - Usædvanlige drømme eller mareridt - Krampeanfald - Snurrende (sovende) fornemmelse og/eller følelsesløshed - Hjertebanken - Lavt blodtryk - Muskelsvaghed
English: 3 ml, Low density polyethylene ampoule.
Danish: 3 ml ampul af lavdensitetspolyethylen.
English: The effects of race on the pharmacokinetics of levofloxacin administered by inhalation have not been studied.
Danish: Virkningen af race på farmakokinetikken for levofloxacin, der administreres ved hjælp af inhalation, er ikke blevet undersøgt.
English: - Do not put any medicines other than Quinsair in the Zirela Nebuliser Handset.
Danish: - Undlad at komme anden medicin end Quinsair i Zirela-nebulisatorhåndsættet.
English: This includes tendon, muscle and joint pain of the upper and lower limbs, difficulty walking, abnormal sensations such as pins and needles, tingling, tickling, numbness or burning (paraesthesia), sensory disorders including impairment of vision, taste and smell, and hearing, depression, memory impairment, severe fatigue, and severe sleep disorders.
Danish: De omfatter sene-, muskel- og ledsmerter i de øvre eller nedre lemmer, gangbesvær, unormale fornemmelser, såsom stikken og prikken, snurren, kildren, følelsesløshed eller brændende fornemmelse (paræstesi), sanseforstyrrelser, herunder syns-, smags- og hørenedsættelse samt nedsat lugtesans, depression, hukommelsessvigt, udpræget træthed og svære søvnforstyrrelser.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON BOX CONTAINING 56 (14 SACHETS OF 4) AMPOULES
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE INDRE PAPÆSKE, DER INDEHOLDER 56 (14 BREVE MED HVER 4) AMPULLER
English: Cases of hepatic necrosis up to fatal hepatic failure have been reported with systemically administered levofloxacin, primarily in patients with severe underlying diseases (e.g. sepsis, see section 4.8).
Danish: Der er ved systemisk administration af levofloxacin rapporteret tilfælde af levernekrose op til letal leverinsufficiens, primært hos patienter med svære underliggende sygdomme (f.eks. sepsis, se pkt.
English: ≥ 12 to < 18 years, n (%) ≥ 18 years, n (%) Baseline mean (SD) Relative change from Baseline to Day 28
Danish: ≥ 12 til < 18 år, n (%) ≥ 18 år, n (%)
English: Ampoule
Danish: Ampul
English: Therefore, if levofloxacin has to be used in these patients, potential occurrence of haemolysis should be monitored.
Danish: Disse patienter skal derfor overvåges for potentiel forekomst af hæmolyse, hvis de skal behandles med levofloxacin.
English: Outer box
Danish: Ydre æske
English: One ampoule contains levofloxacin hemihydrate equivalent to 240 mg of levofloxacin.
Danish: Èn ampul indeholder levofloxacinhemihydrat svarende til 240 mg levofloxacin.
English: Taking Quinsair at the same time as these medicines could increase your risk of a fit (seizure).
Danish: Hvis du tager Quinsair samtidig med disse lægemidler, kan det øge din risiko for et krampeanfald.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING FOIL LAMINATE SACHET CONTAINING 4 AMPOULES
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE FOLIELAMINATBREV, DER INDEHOLDER 4 AMPULLER
English: Caution should be taken when using fluoroquinolones, including levofloxacin, in patients with known risk factors for prolongation of the QT interval (see sections 4.5, 4.8 and 4.9) such as, for example:
Danish: Der bør udvises forsigtighed, når fluorquinoloner, herunder levofloxacin, anvendes til patienter med kendte risikofaktorer for en forlængelse af QT-intervallet (se pkt.
English: Hazard ratio [95% CI] d: P = 0.154 e
Danish: Risikorate [95% CI] d: P = 0,154 e
English: Keeping the handset level, place the mouthpiece in the patient's mouth making sure their lips are closed around it.
Danish: Man skal sørge for, at patientens læber lukker omkring mundstykket.
English: Quinsair is not recommended for use in patients with severe renal impairment (creatinine clearance ˂ 20 ml/min).
Danish: Quinsair bør ikke anvendes til patienter med svært nedsat nyrefunktion (kreatininclearance < 20 ml/minut).
English: Levofloxacin is contraindicated in patients with a history of epilepsy (see section 4.3) and, as with other quinolones, should be used with extreme caution in patients predisposed to seizures or on concomitant treatment with active substances that lower the cerebral seizure threshold, such as theophylline (see section 4.5).
Danish: 4.3) og bør i lighed med andre quinoloner anvendes med yderste forsigtighed til patienter, der er prædisponeret for krampeanfald eller er i samtidig behandling med aktive stoffer, der sænker den cerebrale krampetærskel, såsom theophyllin (se pkt.
English: Holding the handset level, press and hold the on/off button on the controller for a few seconds.
Danish: Idet håndsættet holdes vandret, trykkes på afbryderknappen på styreenheden, og denne holdes nede i nogle få sekunder.
English: LS mean [95% CI]: P = 0.046 e
Danish: LS-middelværdi [95% CI]: P = 0,046 e
English: If acute, symptomatic bronchospasm occurs after receiving treatment, patients may benefit from the use of a short-acting inhaled bronchodilator prior to subsequent doses (see section 4.2).
Danish: Hvis der forekommer akut, symptomatisk bronkospasme efter inhalation af behandlingen, kan patienten muligvis have fordel af at bruge en korttidsvirkende, inhaleret bronkodilator forud for efterfølgende doser (se pkt.
English: The effects of renal impairment on the pharmacokinetics of levofloxacin administered by inhalation have not been studied.
Danish: Virkningerne af nedsat nyrefunktion på farmakokinetikken for levofloxacin, der administreres ved hjælp af inhalation, er ikke blevet undersøgt.
English: How to use Quinsair
Danish: Sådan skal du bruge Quinsair
English: Bronchodilators;
Danish: Bronkodilatorer,
English: Headache, Dizziness*
Danish: Hovedpine, Svimmelhed*
English: 1 Very rare cases of prolonged (up to months or years), disabling and potentially irreversible serious drug reactions affecting several, sometimes multiple, system organ classes and senses (including reactions such as tendonitis, tendon rupture, arthralgia, pain in extremities, gait disturbance, neuropathies associated with paraesthesia, depression, fatigue, memory impairment, sleep disorders, and impairment of hearing, vision, taste and smell) have been reported in association with the use of quinolones and fluoroquinolones in some cases irrespective of pre-existing risk factors (see section 4.4).
Danish: 1 Meget sjældne tilfælde af langvarige (op til måneder eller år), invaliderende og potentielt irreversible alvorlige bivirkninger, der påvirker flere, nogle gange flere systemorganklasser og sanser (herunder reaktioner som tendinitis, seneruptur, artralgi, smerter i ekstremiteter, gangforstyrrelse, neuropatier forbundet med paræstesi, depression, træthed, hukommelsessvigt, søvnforstyrrelser og nedsat hørelse, syn, lugtesans og smagssans) er blevet rapporteret i forbindelse med brugen af quinoloner og fluorquinoloner, i nogle tilfælde uanset præeksisterende risikofaktorer (se pkt.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Quinsair 240 mg nebuliser solution
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Quinsair 240 mg inhalationsvæske til nebulisator, opløsning Levofloxacin
English: Hazard ratio [95% CI] d: P = 0.040 e
Danish: Risikorate [95% CI] d: P = 0,040 e
English: - Do not mix Quinsair with any other medicines in the Zirela Nebuliser Handset.
Danish: - Undlad at blande Quinsair med anden medicin i Zirela-nebulisatorhåndsættet.
English: Very rare cases of long lasting (up to months or years) or permanent adverse drug reactions, such as tendon inflammations, tendon rupture, joint pain, pain in the limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, burning, numbness or pain (neuropathy), depression, fatigue, sleep disorders, memory impairment, as well as impairment of hearing, vision, and taste and smell have been associated with administration of quinolone and fluoroquinolone antibiotics, in some cases irrespective of pre-existing risk factors.
Danish: Meget sjældne tilfælde af langvarige (op til måneder eller år) eller permanente bivirkninger, såsom senebetændelse, senebristning, ledsmerter, smerter i lemmerne, gangbesvær, unormale fornemmelser, såsom prikken og stikken, snurren, kildren, brændende fornemmelse, følelsesløshed eller smerter (neuropati), depression, træthed, søvnforstyrrelser, hukommelsessvigt samt høre-, syns- og smagsnedsættelse samt nedsat lugtesans er blevet forbundet med brug af quinolon- og fluorquinolonantibiotika, i nogle tilfælde uanset om der var allerede eksisterende risikofaktorer eller ej.
English: Hepatic impairment No dose adjustment is required (see section 5.2).
Danish: Nedsat leverfunktion Der er ikke behov for dosisjustering (se pkt.
English: Peripheral sensory neuropathy, Peripheral sensory motor neuropathy, Dyskinesia, Extrapyramidal disorder,
Danish: Perifer sensorisk neuropati,
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Danish: LS-middelværdi (SE)
English: Confusional state, Nervousness
Danish: Psykiske forstyrrelser1 Konfusionstilstand, Nervøsitet
English: Common: may affect up to 1 in 10 people - Fungal infection around vagina - Insomnia or difficulty sleeping - Headache - Dizziness - Ringing or noise in the ears (tinnitus) - Change to the voice - Feeling and being sick - Abdominal pain - Diarrhoea - Constipation - Rash - Joint or muscle pain - Fever - Abnormal blood test results (increased levels of certain liver enzymes or bilirubin in the blood,
Danish: Almindelige: opstår hos op til 1 bruger ud af 10 - Svampeinfektion omkring skeden - Søvnløshed eller søvnproblemer - Hovedpine - Svimmelhed - Ringen eller hylen for ørerne (tinnitus) - Ændring af stemmen - Kvalme og opkastningMavesmerter - Diarré - Forstoppelse - Udslæt - Led- eller muskelsmerter - Feber - Unormale blodanalyseresultater (forhøjede niveauer af visse leverenzymer eller bilirubin i blodet og nedsat nyrefunktionstest) - Nedsat lungefunktionstest - Forøget eller nedsat mængde sukker (glukose) i blodet
English: Tendinitis was reported in patients with CF receiving Quinsair as an uncommon adverse reaction during clinical trials (see section 4.8).
Danish: Tendinitis er i kliniske forsøg rapporteret som en ikke almindelig bivirkning hos patienter med CF, der har fået Quinsair (se pkt.
English: If acute symptomatic bronchospasm occurs after receiving Quinsair, patients may benefit from the use of a short-acting inhaled bronchodilator at least 15 minutes to 4 hours prior to subsequent doses (see sections 4.4 and 4.8).
Danish: Hvis der forekommer akut symptomatisk bronkospasme efter inhalation af Quinsair, kan patienten muligvis have fordel af at bruge en korttidsvirkende inhaleret bronkodilator mindst 15 minutter til 4 timer forud for efterfølgende doser (se pkt.
English: What Quinsair is and what it is used for What you need to know before you use Quinsair How to use Quinsair
Danish: Det skal du vide, før du begynder at bruge Quinsair Sådan skal du bruge Quinsair Bivirkninger
English: Hearing loss*
Danish: Høretab*
English: Photosensitisation has been reported with levofloxacin (see section 4.8).
Danish: Lyssensibilisering er blevet rapporteret med levofloxacin (se pkt.
English: Fatigue/asthenia, Exercise tolerance decreased
Danish: Træthed/asteni, Nedsat anstrengelsestolerance
English: How and when do I replace the Zirela Nebuliser Handset?
Danish: Udskiftning af Zirela-nebulisatorhåndsættet?
English: Baseline to Day 28 of Cycle 1
Danish: Ændring fra baseline til dag 28 i cyklus 1
English: Dyspnoea,
Danish: Ligamentruptur,
English: Quinsair 240 mg nebuliser solution Levofloxacin
Danish: Quinsair 240 mg inhalationsvæske til nebulisator, opløsning Levofloxacin
English: NAME OF THE MEDICINAL PRODUCT Quinsair 240 mg nebuliser solution
Danish: LÆGEMIDLETS NAVN Quinsair 240 mg inhalationsvæske til nebulisator, opløsning
English: Once an ampoule is opened, the contents should be used immediately (see section 6.6).
Danish: Indholdet skal anvendes straks efter åbning af en ampul (se pkt.
English: Cycles 1 to 6), the LS Mean change in FEV1 percent predicted ranged between 3.6% to 4.6% except in Cycle 6, where it was close to baseline (-0.15%).
Danish: For den delgruppe af patienter, der fik Quinsair gennem kerne- og forlængelsesfaserne (det vil sige cyklus 1 til 6), lå ændringen af LS-middelværdien for forventet FEV1-procent i intervallet mellem 3,6% og 4,6% bortset fra i cyklus 6, hvor den var tæt på baseline (-0,15%).
English: Quinolones may lower the seizure threshold and may trigger seizures (see section 4.8).
Danish: Quinoloner kan sænke krampetærsklen og kan udløse krampeanfald (se pkt.
English: Symptoms include: - General itching and feeling of heat - especially affecting the scalp, mouth, throat, palms or soles of your feet - Severe wheezing, or noisy or difficult breathing - Severe hives/nettle rash - Swelling of the lips, face, throat or tongue - Pale or greyish skin colour - A fast heart beat - Faintness or passing out
Danish: håndfladerne og fodsålerne - Kraftig hiven efter vejret eller støjende eller besværet vejrtrækning - Kraftig nældefeber - Hævede læber, hævet ansigt, hals eller tunge - Bleg eller grålig hudfarve - En hurtig hjerterytme - Kraftesløshed eller besvimelse
English: 5th Inhaled steroids
Danish: Inhalerede steroider
English: However, Quinsair is not recommended for use in patients with severe renal impairment (creatinine clearance ˂ 20 ml/min, see section 4.2).
Danish: Quinsair bør dog ikke anvendes til patienter med svært nedsat nyrefunktion (kreatininclearance < 20 ml/minut, se pkt.
English: FEV1 Relative change from Baseline to Day 28 of Cycle 2
Danish: Relativ ændring i FEV1 fra baseline til dag 28 i cyklus 2
English: However, in the absence of human data and findings in non-clinical studies suggesting a risk of damage by fluoroquinolones to the weight-bearing cartilage of the growing organism, use of Quinsair is contraindicated during pregnancy (see sections 4.3 and 5.3).
Danish: Anvendelse af Quinsair er dog kontraindiceret under graviditet på grund af manglende data fra mennesker og resultater fra prækliniske studier, der tyder på en risiko for, at fluorquinoloner kan skade den vægtbærende brusk hos den voksende organisme (se pkt.
English: FEV1 Relative change from Baseline to Day 28 of Cycle 3
Danish: Relativ ændring i FEV1 fra baseline til dag 28 i cyklus 3
English: There is insufficient information on the excretion of levofloxacin in human milk; however, other fluoroquinolones are excreted in breast milk.
Danish: Data for udskillelse af levofloxacin i human mælk er utilstrækkelige.
English: Systemic levofloxacin
Danish: Systemisk levofloxacin
English: - Kidney problems.
Danish: - Nyreproblemer.
English: - Severe skin reactions
Danish: - Kraftige hudreaktioner
English: Final study report - by Q2 2022.
Danish: kvartal 2022.
English: PHARMACEUTICAL FORM Nebuliser solution.
Danish: LÆGEMIDDELFORM Inhalationsvæske til nebulisator, opløsning.
English: FEV1 Relative change from Baseline to Day 28 of Cycle 1
Danish: Relativ ændring i FEV1 fra baseline til dag 28 i cyklus 1
English: If acute, symptomatic bronchoconstriction occurs after receiving Quinsair, patients may benefit from the use of a short-acting inhaled bronchodilator prior to subsequent doses (see sections 4.2 and 4.4).
Danish: Hvis der forekommer akut, symptomatisk bronkokonstriktion efter inhalation af Quinsair, kan patienten muligvis have fordel af at bruge en korttidsvirkende, inhaleret bronkodilator forud for efterfølgende doser (se pkt.
English: Clear, pale yellow solution.
Danish: Klar, lysegul opløsning.
English: Replace any unused, unopened ampoules from the strip back into the sachet to protect them from light.
Danish: Læg eventuelle ubrugte, uåbnede ampuller fra strippen tilbage i brevet, så de beskyttes mod lys.
English: The controller will ‘beep' once and the status light will turn green. After a few seconds, an aerosol mist will begin to flow into the aerosol chamber of the Zirela Nebuliser Handset.
Danish: Efter nogle få sekunder begynder en aerosoltåge at strømme ind i aerosolkammeret på Zirela-nebulisatorhåndsættet.
English: PHARMACEUTICAL FORM AND CONTENTS Nebuliser solution
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Inhalationsvæske til nebulisator, opløsning 4 ampuller
English: Not known: frequency cannot be estimated from the available data - Low numbers of all types of cells in the blood - Diabetic coma - Severe mental problems (which in very rare cases may lead to self-harm) - Pain, burning, tingling, numbness and/or weakness in the limbs (neuropathy) - Involuntary muscle movements, twitching or spasms - Fainting - Severe throbbing headaches with loss of eyesight - Temporary loss of vision - Rapid or abnormal heart beat - Inflammation of the lung - Severe skin reactions such as painful blistering or lesions possibly in the mouth, nose or vagina - Increased sensitivity of the skin to sunlight or UV light (sunbeds or other UV lamps) - Inflammation of the blood vessels - Inflammation of the mouth or lips - Rapid breakdown of muscles - Inflammation of a tendon or a broken tendon - Pain including pain in the back, chest, arms and legs and arms
Danish: Ikke almindelige: opstår hos op til 1 bruger ud af 100 - Svampeinfektion i munden - Lavt antal røde blodlegemer i blodet (anæmi) eller de celler i blodet, der hjælper med til at størkne det (blodplader) - Lavt eller højt antal hvide blodlegemer i blodet - Følelse af angst, rastløshed eller uro og/eller depression - Nedsat smagssans - Følelse af søvnighed - Ændringer af synet - Tab af hørelse - Forøget hjerterytme - Vejrtrækningsbesvær - Kløgning (maveindholdet tvinges ved sammentrækninger af mellemgulvet op i spiserøret, men ikke op i svælget) - Fordøjelsesbesvær - Luft i maven - Nældefeber og kløe - Brystvægssmerter - Nyresvigt - Ændringer i hjerterytmen
English: Rhabdomyolysis, Tendon rupture, Ligament rupture, Muscle rupture, Arthritis
Danish: Knogler, led, muskler og bindevæv1
English: Transient vision loss
Danish: Forbigående synstab
English: Hypoglycaemic coma
Danish: Magnesiumchloridhexahydrat
English: In the absence of human data and findings in non-clinical studies suggesting a risk of damage by fluoroquinolones to the weight-bearing cartilage of the growing organism, use of Quinsair is contraindicated in breast-feeding women (see sections 4.3 and 5.3).
Danish: Anvendelse af Quinsair er kontraindiceret til ammende kvinder på grund af manglende data fra mennesker og resultater fra prækliniske studier, der tyder på en risiko for, at fluorquinoloner kan skade den vægtbærende brusk hos den voksende organisme (se pkt.
English: Each ml of nebuliser solution contains levofloxacin hemihydrate equivalent to 100 mg of levofloxacin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver ml inhalationsvæske til nebulisator, opløsning indeholder levofloxacinhemihydrat svarende til 100 mg levofloxacin.
English: Serum PK exposures were similar when comparing children receiving the weight-based regimen and adults receiving
Danish: PK-eksponeringer i serum var omtrent ens hos børn, der fik det vægtbaserede regime, og vokse, der fik Quinsair 240 mg en gang dagligt.
English: If you use more Quinsair than you should
Danish: Hvis du har brugt for meget Quinsair
English: Vision disorders
Danish: Synsforstyrrelser