FrancophonIA/ELRC3.0 huggingface dataset:
English: Depending on the mechanism of resistance, organisms with acquired resistance to penicillins may demonstrate reduced susceptibility or resistance to cefuroxime.
Danish: Afhængigt af resistensmekanismen kan organismer med erhvervet resistens over for penicilliner demonstrere reduceret følsomhed eller resistens over for cefuroxim.
English: Contents of the pack and other further information
Danish: Pakningsstørrelser og yderligere oplysninger
English: Some strains that produce beta-lactamases are susceptible or intermediate to 3rd or 4th generation cephalosporins with these breakpoints and should be reported as found, i.e. the presence or absence of an ESBL does not in itself influence the categorization of susceptibility.
Danish: Nogle arter, som producerer beta-laktamaser, er følsomme eller delvist følsomme over for 3. og 4. generationscefalosporiner med disse grænseværdier og skal rapporteres som værende til stede, dvs. at tilstedeværelse eller fravær af ESBL ikke i sig selv påvirker kategoriseringen af følsomhed.
English: • a decrease in the number of blood platelets (cells that help blood to clot)
Danish: • nedsat antal blodplader (celler, der får blodet til at størkne)
English: Zinnat suspension, must be stored in the fridge between 2°C and 8°C.
Danish: Zinnat suspension skal opbevares i køleskab mellem 2 °C og 8 °C.
English: Zinnat is indicated for the treatment of the infections listed below in adults and children from the age of 3 months (see sections 4.4 and 5.1).
Danish: Zinnat er indiceret til behandling af nedenstående infektioner hos voksne og børn i alderen fra 3 måneder (se pkt.
English: You must look out for certain symptoms, such as allergic reactions, fungal infections (such as candida) and severe diahorrea (pseudomembranous colitis) while you are taking Zinnat.
Danish: Du skal holde øje med visse symptomer, såsom overfølsomhedsreaktioner, svampeinfektioner (såsom candidiasis) og alvorlig diarré (pseudomembranøs colitis), mens du bruger Zinnat.
English: Following a single dose of cefuroxime axetil 500 mg tablet to 12 healthy volunteers, the apparent volume of distribution was 50 L (CV%=28%).
Danish: Efter en enkelt tabletdosis på 500 mg cefuroximaxetil til 12 raske, frivillige forsøgspersoner var det tilsyneladende fordelingsvolumen 50 l (CV % = 28 %).
English: • if you are pregnant, think you might be pregnant or are planning to become pregnant
Danish: Tal med lægen, inden du tager Zinnat: hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid hvis du ammer.
English: Invert the bottle and rock vigorously (for at least 15 seconds).
Danish: Vend flasken på hovedet og vip den kraftigt (i mindst 15 sekunder).
English: In older infants (aged >3 months) and in children, the pharmacokinetics of cefuroxime are similar to that observed in adults.
Danish: Hos ældre spædbørn (> 3 uger gamle) og børn svarer cefuroxims farmakokinetik til farmakokinetikken hos voksne.
English: It is important that you take the full course of Zinnat.
Danish: Det er vigtigt, at du gennemfører hele behandlingen med Zinnat.
English: Zinnat suspension can be diluted in cold fruit juices, or milk drinks but should be taken immediately.
Danish: Zinnat suspension kan fortyndes med kold frugtjuice eller mælkeholdige drikkevarer og skal derefter drikkes straks.
English: Some patients may get a high temperature (fever), chills, headache, muscle pain and skin rash while being treated with Zinnat for Lyme disease.
Danish: Nogle patienter kan få høj temperatur (feber), kuldegysninger, hovedpine, muskelsmerter og udslæt, mens de er i behandling med Zinnat for Lyme-sygdom.
English: For step-by-step instructions on how to make up Zinnat suspension see Instructions for reconstitution at the end of this leaflet.
Danish: For trinvis vejledning i klargøring af Zinnat suspension, se Vejledning til rekonstitution sidst i denne indlægsseddel.
English: The sucrose content of cefuroxime axetil suspension and granules should be taken into account when treating diabetic patients and appropriate advice provided.
Danish: Indhold af saccharose i cefuroximaxetil-suspension og -granulat skal tages i betragtning, når diabetespatienter behandles, og passende rådgivning skal gives.
English: Zinnat tablets should not be crushed and are therefore unsuitable for treatment of patients who cannot swallow tablets.
Danish: Zinnat tabletter må ikke knuses og er derfor ikke egnede til behandling af patient ta
English: Don't stop unless your doctor advises you toeven if you are feeling better.
Danish: Du må ikke stoppe, medmindre lægen råder dig til at stoppe - heller ikke, selvom du har fået det bedre.
English: Zinnat suspension also contains aspartame, which is a source of phenylalanine.
Danish: Zinnat suspension indeholder også aspartam, som er en fenylalaninkilde.
English: 2 Uncomplicated UTI (cystitis) only (see section 4.1).
Danish: 2 Kun ukompliceret UTI (cystitis) (se pkt.
English: Patients should be reassured that this is a common and usually self-limiting consequence of antibiotic treatment of Lyme disease (see section 4.8).
Danish: Patienter skal orienteres om, at dette er en almindelig og relia normalt selvlimiterende onsekvens af antibiotikabehandling af Lyme-sygdom (se pkt.
English: The Jarisch-Herxheimer reaction has been seen following cefuroxime axetil treatment of Lyme disease.
Danish: Jarisch-Herxheimers reaktion er set efter cefuroximaxetil-behandling af Lyme-sygdom.
English: No special precaution is necessary in the elderly patients with normal renal function at dosages up to the normal maximum of 1 g per day.
Danish: Hos ældre patienter med normal nyrefunktion er det ikke nødvendigt med særlige forholdsregler ved doser på op til den normale maksimale dosis på 1 g om dagen.
English: If desired, Zinnat suspension from multidose bottles can be further diluted in cold fruit juices, or milk drinks and should be taken immediately.
Danish: Hvis det ønskes, kan Zinnat suspension fra flerdosisbeholdere yderligere fortyndes i kold frugtjuice eller mælkeholdige drikkevarer umiddelbart inden indtagelse.
English: Take the syringe out of the bottle and wash it thoroughly in clean water.
Danish: Tag sprøjten af flasken og vask den grundigt i rent vand.
English: Add the total amount of water to the bottle as stated on its label or as stated on the cup (if supplied).
Danish: Tilsæt den fulde mængde vand, som angivet på flaskens etiket eller på målebægeret (hvis et medfølger).
English: In children Zinnat oral suspension may be used.
Danish: Zinnat oral opløsning kan anvendes til børn.
English: • inflammation of the liver (hepatitis).
Danish: • leverbetændelse (hepatitis).
English: Pull out syringe plunger until the syringe contains the first part of your full dose.
Danish: Træk sprøjtens stempel ud, indtil sprøjten indeholder den første portion af den totale dosis.
English: Cephalosporins as a class tend to be absorbed onto the surface of red cells membranes and react with antibodies directed against the drug to produce a positive Coombs' test (which can interfere with crossmatching of blood) and very rarely haemolytic anaemia.
Danish: Cefalosporiner som klasse har tendens til at blive adsorberet til overfladen af røde blodcellemembraner og reagere med antistoffer rettet mod lægemidlet og derved udvikle en positiv Coombs' test (hvilket kan interferere med blodtype-matching) og meget sjældent hæmolytisk anæmi.
English: A small number of people taking Zinnat get an allergic reaction or potentially serious skin reaction.
Danish: Et lille antal af de personer, som tager Zinnat, får en allergisk reaktion eller en hudreaktion, som kan blive alvorlig.
English: For cephalosporins, the most important pharmacokinetic-pharmacodynamic index correlating with in vivo efficacy has been shown to be the percentage of the dosing interval (%T) that the unbound concentration remains above the minimum inhibitory concentration (MIC) of cefuroxime for individual target species (i.e. %T>MIC).
Danish: For cefalosporiner er det vist, at det vigtigste farmakokinetiske-farmakodynamiske indeks, der korrelerer med effekten in vivo, er den procent af tiden i doseringsintervallet (%T), hvor den ubundne koncentration ligger over den mindste hæmmende koncentration (MIC) af cefuroxim for de individuelle target-arter (dvs. %T > MIC).
English: There are limited data from the use of cefuroxime in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af cefuroxim til gravide kvinder.
English: The reconstituted suspension or granules should not be mixed with hot liquids.
Danish: Suspensionen eller granulatet må ikke blandes med varme væsker.
English: Italy - Oraxim
Danish: Italien - Oraxim
English: Adverse effects at therapeutic doses are not expected, although a risk of diarrhoea and fungus infection of the mucous membranes cannot be excluded.
Danish: Der forventes ikke bivirkninger ved terapeutiske doser, men risiko for diarré og svampeinfektion i slimhinder kan ikke udelukkes.
English: Acute otitis media
Danish: Akut otitis media
English: If you need a blood test:
Danish: Hvis du skal have taget en blodprøve:
English: Paediatric population The safety profile for cefuroxime axetil in children is consistent with the profile in adults.
Danish: Sikkerhedsprofilen for cefuroximaxetil hos børn stemmer overens med sikkerhedsprofilen hos voksne.
English: In patients with markedly impaired renal function it is recommended that the dosage of cefuroxime should be reduced to compensate for its slower excretion.
Danish: Hos patienter med markant nedsat nyrefunktion anbefales det at reducere doseringen af cefuroxim for at kompensere for den langsommere udskillelse.
English: Remove the syringe from the adapter.
Danish: Fjern sprøjten fra tilpasningsstykket.
English: If you forget to take Zinnat
Danish: Hvis du har glemt at tage Zinnat
English: If you have an intolerance to aspartame or have a condition called phenylketonuria (PKU):
Danish: Hvis du er overfølsom over for aspartam eller har en sygdom, der kaldes fenylketonuri (PKU, Føllings sygdom):
English: The usual dose of Zinnat is 250 mg to 500 mg twice daily depending on the severity and type of infection.
Danish: Den sædvanlige dosis af Zinnat er 250-500 mg 2 gange daglig, afhængigt af infektionens sværhedsgrad og type.
English: EXPIRY DATE EXP {MM YYYY} SPECIAL STORAGE CONDITIONS [To be completed nationally]
Danish: UDLØBSDATO EXP {MM ÅÅÅÅ} SÆRLIGE OPBEVARINGSBETINGELSER [Udfyldes nationalt]
English: For children who can't take Zinnat using a spoon, a dosing syringe with a 5 mL graduation is supplied.
Danish: Til børn, der ikke kan tage Zinnat med en ske, er en doseringssprøjte med inddeling på 5 ml vedlagt.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS/STRIPS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS BLISTERKORT/BLISTERSTRIPS
English: 15 mg/kg dosage for otitis media and more serious infections Age
Danish: Tabel 4: 15 mg/kg dosering til otitis media og alvorligere infektioner Alder
English: • fungal infections.
Danish: • svampeinfektioner.
English: Cefuroxime is effectively removed by dialysis.
Danish: Cefuroxim fjernes effektivt ved dialyse.
English: The renal clearance is in the region of 125 to 148 mL/min/1.73 m2.
Danish: Den renale clearance ligger mellem 125 og 148 ml/min/1,73 m2.
English: • Acute bacterial sinusitis.
Danish: • Akut bakteriel sinusitis.
English: Always take this medicine exactly as your doctor or pharmacist has told you to.
Danish: Tag altid denne medicin nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: Greece - Zinadol
Danish: Grækenland - Zinadol
English: 3 Susceptibility of staphylococci to cephalosporins is inferred from the methicillin susceptibility except for ceftazidme and cefixime and ceftibuten, which do not have breakpoints and should not be used for staphylococcal infections.
Danish: 3 Følsomhed af stafylokokker over for cefalosporiner er baseret på følsomhed over for methicillin med undtagelse af ceftazidim, cefixim og ceftibuten, som ikke har grænseværdier, og som ikke bør anvendes til stafylokokinfektioner.
English: As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions have been reported.
Danish: Som med alle andre beta-laktamantibiotika er der observeret alvorlige og i nogle tilfælde letale overfølsomhedsreaktione I tilfælde af alvorlige overfølsomhe r.
English: No differences in the pharmacokinetics of cefuroxime were observed between males and females.
Danish: Der blev ikke observeret forskelle i cefuroxims farmakokinetik mellem mænd og kvinder.
English: Following administration of cefuroxime axetil tablets peak serum levels (2.9 µg/mL for a 125 mg dose, 4.4 µg/mL for a 250 mg dose, 7.7 µg/mL for a 500 mg dose and 13.6 µg/mL for a 1000 mg dose) occur approximately 2.4 hours after dosing when taken with food.
Danish: Efter administration af cefuroximaxetil-tabletter opnås maksimal serumkoncentration (2,9 µg/ml for dosis på 125 mg, 4,4 µg/ml for dosis på 250 mg, 7,7 µg/ml for dosis på 500 mg og 13,6 µg/ml for dosis på 1000 mg) cirka 2,4 timer efter administration, når dosis tages sammen med et måltid.
English: • the lungs or chest
Danish: • lunger eller brystkassen
English: Instructions for reconstitution
Danish: Vejledning til rekonstitution
English: The dose in infants and children 3 months to 18 years is 10 mg/kg twice daily for most infections, to a maximum of 250 mg daily.
Danish: Dosis til spædbørn og børn i alderen 3 måneder til 18 år er 10 mg/kg 2 gange daglig for de fleste infektioner, til højst 250 mg daglig.
English: There are no data available for patients with hepatic impairment.
Danish: Der er ingen data tilgængelig for patienter med nedsat leverfunktion.
English: Dose (mg) twice daily
Danish: Dosis (mg) 2 gange daglig
English: Adults and children (≥40 kg)
Danish: Tabel 1: Voksne og børn  40 kg
English: Cefuroxime axetil may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.
Danish: Cefuroximaxetil kan påvirke tarmfloraen, hvilket kan medføre lavere reabsorption af østrogen og nedsat effekt af orale kontraceptiva (kombinationspræparater).
English: • skin reactions (including severe)
Danish: • hudreaktioner (hvoraf nogle kan være alvorlige)
English: Cefuroxime axetil suspension contains aspartame, which is a source of phenylalanine and so should be used with caution in patients with phenylketonuria.
Danish: Cefuroximaxetil-suspension indeholder aspartam, som er en fenylalaninkilde, og skal derfor anvendes med forsigtighed hos patienter med fenylketonuri.
English: In otitis media or more severe infections the recommended dose is 15 mg/kg twice daily to a maximum of 500 mg daily.
Danish: Ved otitis media eller alvorligere infektioner er den anbefalede dosis 15 mg/kg 2 gange daglig til højst 500 mg daglig.
English: Therefore, as with all such antibiotics, in patients with markedly impaired renal function (i.e. C1cr <30 mL/minute) it is recommended that the dosage of cefuroxime should be reduced to compensate for its slower excretion (see section 4.2).
Danish: Som for alle denne type antibiotika anbefales det derfor, at dosis reduceres hos patienter med markant nedsat nyrefunktion (dvs. C1cr < 30 ml/minut) for at kompensere for den langsommere udskillelse (se pkt.
English: The rate of absorption of cefuroxime from the suspension is reduced compared with the tablets, leading to later, lower peak serum levels and reduced systemic bioavailability (4 to 17% less).
Danish: Sammenlignet med tabletter er absorptionshastigheden for suspensionen lavere, hvilket medfører senere og lavere maksimal plasmakoncentration samt nedsat systemisk biotilgængelighed (4-17 % mindre).
English: Special care is indicated in patients who have experienced an allergic reaction to penicillins or other betalactam antibiotics because there is a risk of cross-sensitivity.
Danish: Der skal udvises særlig forsigtighed hos patienter, som har haft en allergisk reaktion over for penicilliner eller andre beta-laktamantibiotika, på grund af risiko for krydsallergi.
English: Concentrations of cefuroxime in excess of the minimum inhibitory levels for common pathogens can be achieved in the tonsilla, sinus tissues, bronchial mucosa, bone, pleural fluid, joint fluid, synovial fluid, interstitial fluid, bile, sputum and aqueous humor.
Danish: Cefuroxim-koncentrationer over den mindste hæmmende koncentration for almindelige patogener kan opnås i tonsiller, sinusvæv, bronkial mucosa, knogler, pleuravæske, ledvæske, synovialvæske, interstitielvæske, galde, sputum og kammervæske.
English: • an increase in a type of white blood cell (eosinophilia) • an increase in liver enzymes.
Danish: stigning i en type hvide blodlegemer (eosinofili) stigning i leverenzymer.
English: 125 mg/5 mL, 250 mg/5 mL granules for oral suspension In infants (from the age of 3 months) and children with a body mass of less than 40 kg, it may be preferable to adjust dosage according to weight or age.
Danish: 125 mg/5 ml, 250 mg/5 ml granulat til oral suspension Hos spædbørn (fra 3 måneder) og børn med en kropsvægt under 40 kg kan det være hensigtsmæssigt at justere dosis i henhold til vægt eller alder.
English: Refrigerate immediately at between 2 and 8°C.
Danish: Sæt omgående flasken i køleskab ved 2-8 °C.
English: 10 mg/kg dosage for most infections
Danish: Tabel 3: 10 mg/kg dosering til de fleste infektioner Alder
English: In addition the incidence of adverse reactions associated with cefuroxime axetil may vary according to the indication.
Danish: Hyppigheden for bivirkninger tilknyttet cefuroximaxetil kan ydermere variere afhængigt af indikationen.
English: There are no data on the effects of cefuroxime axetil on fertility in humans.
Danish: Der er ingen data om cefuroximaxetils påvirkning af fertiliteten hos mennesker.
English: Spain - Cefuroxima Allen
Danish: Spanien - Cefuroxima Allen
English: Do NOT squirt the medicine out in a jet.
Danish: Medicinen må ikke sprøjtes ud i en stråle.
English: Acute tonsillitis and pharyngitis, acute bacterial sinusitis
Danish: Akut tonsillitis og faryngitis, akut bakteriel sinusitis
English: For optimal absorption cefuroxime axetil suspension should be taken with food.
Danish: Oral anvendelse For at sikre optimal absorption skal cefuroximaxetil-suspension tages sammen med mad.
English: Shake the bottle to loosen the granules.
Danish: Ryst flasken for at løsne granulatet.
English: After oral administration cefuroxime axetil is absorbed from the gastrointestinal tract and rapidly hydrolysed in the intestinal mucosa and blood to release cefuroxime into the circulation.
Danish: Efter oral administration absorberes cefuroximaxetil fra mave-tarmkanalen og hydrolyseres hurtigt i tarmslimhinden og blodet, hvorefter cefuroxim frigives i kredsløbet.
English: Medicines like Zinnat can cause inflammation of the colon (large intestine), causing severe diarrhoea, usually with blood and mucus, stomach pain, fever
Danish: Medicin som Zinnat kan give betændelse i tyktarmen, som medfører alvorlig diarré, oftest med blod og slim, mavesmerter og feber
English: Since cefuroxime is primarily eliminated by the kidney, the presence of hepatic dysfunction is expected to have no effect on the pharmacokinetics of cefuroxime.
Danish: Eftersom cefuroxim primært elimineres via nyrerne, forventes nedsat leverfunktion ikke at påvirke farmakokinetikken af cefuroxim.
English: Don't mix Zinnat with hot liquids.
Danish: Du må ikke blande Zinnat med varme væsker.
English: Cefuroxime Oral use
Danish: Cefuroxim Oral anvendelse
English: • Acute streptococcal tonsillitis and pharyngitis.
Danish: • Akut streptokok-tonsillitis og faryngitis.
English: • severe diarrhoea (Pseudomembranous colitis).
Danish: • alvorlig diarré (pseudomembranøs colitis).
English: Zinnat may reduce the effectiveness of the contraceptive pill.
Danish: Zinnat kan nedsætte virkningen af p-piller.
English: With the patient seated in an upright position, place the tip of the syringe just inside the patient's mouth, pointing towards the inside of the cheek.
Danish: Lad patienten sidde i oprejst position og placer spidsen af sprøjten lige inden for patientens mund, pegende mod indersiden af kinden.
English: • severe diarrhoea (pseudomembranous colitis)
Danish: • alvorlig diarré (pseudomembranøs colitis)
English: standard individual dose given every 48 hours
Danish: dividuel standarddosis administreret hver 48. time.
English: 500 mg granules for oral suspension Spain - Zinnat
Danish: 500 mg granulat til oral suspension Spanien - Zinnat
English: Spirochaetes:
Danish: Spirokæter:
English: Drugs which reduce gastric acidity may result in a lower bioavailability of cefuroxime axetil compared with that of the fasting state and tend to cancel the effect of enhanced absorption after food.
Danish: Lægemidler, der nedsætter mavens surhedsgrad, kan nedsætte biotilgængeligheden af cefuroxim sammenlignet med biotilgængeligheden i fastende tilstand og har tendens til at eliminere virkningen af den øgede absorption efter fødeindtagelse.
English: Medicines used to reduce the amount of acid in your stomach (e.g. antacids used to treat heartburn) can affect how Zinnat works.
Danish: Medicin, der nedsætter mængden af mavesyre (f.eks. antacida, som bruges til behandling af halsbrand) kan påvirke virkningen af Zinnat.
English: Pull the plunger up the barrel until the barrels rim is aligned with the mark on the plunger corresponding to the required dose.
Danish: Træk stemplet ned i sprøjten, indtil kanten af stemplet står ud for markeringen på sprøjten, svarende til den ønskede dosis.
English: Dismantle the syringe and wash it thoroughly in fresh drinking water.
Danish: Skil sprøjten ad og vask den grundigt i rent vand.
English: Skin and subcutaneous tissue disorders skin rashes urticaria, pruritus, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (exanthematic necrolysis) (see Immune system disorders), angioneurotic oedema
Danish: Urticaria, pruritus, erythema multiforme, Stevens-Johnsons syndrom, toksisk epidermal nekrolyse (eksantematisk nekrolyse) (se Immunsystemet), angioødem
English: While holding onto the syringe and the plunger to ensure that the plunger does not move, remove the syringe from the bottle, leaving the plastic collar in the bottle neck.
Danish: Mens der holdes fast om både sprøjte og stemplet for at sikre, at stemplet ikke flytter sig, fjernes sprøjten fra flasken.
English: Medicines like Zinnat can cause an overgrowth of yeast (Candida) in the body which can lead to fungal infections (such as thrush).
Danish: Medicin som Zinnat kan medføre vækst af en gærsvamp (Candida) i kroppen, hvilket kan medføre svampeinfektioner (såsom trøske).
English: Cefuroxime axetil undergoes hydrolysis by esterase enzymes to the active antibiotic, cefuroxime.
Danish: Esterase-enzymer hydrolyserer cefuroximaxetil til det aktive antibiotikum, cefuroxim.
English: Spain - Cefuroxima Solasma
Danish: Spanien - Cefuroxima Solasma
English: Streptococcus pneumoniae Moraxella catarrhalis Haemophilus influenzae Non-species related breakpoints1
Danish: Streptococcus pneumoniae Moraxella catarrhalis Haemophilus influenzae Ikke artsrelaterede grænseværdier 1
English: The safety and efficacy of cefuroxime axetil in patients with renal failure have not been established.
Danish: Cefuroximaxetils sikkerhed og virkning hos patienter med nyresvigt er ikke klarlagt.
English: Turn the bottle upside down and rock vigorously for at least 15 seconds.
Danish: Vend flasken på hovedet og vip den kraftigt i mindst 15 sekunder.
English: Don't push too hard and squirt the liquid into the back of your throat or you may choke.
Danish: Du må ikke presse for hårdt og sprøjte væsken ind i den bagerste del af halsen, da du/barnet så kan få væsken galt i halsen.
English: Concurrent administration of probenecid significantly increases the peak concentration, area under the serum concentration time curve and elimination half-life of cefuroxime.
Danish: Samtidig administration af probenecid forlænger signifikant den maksimale koncentration, arealet under serumkoncentration/tid-kurven og eliminationshalveringstiden for cefuroxim.