FrancophonIA/ELRC3.0 huggingface dataset:
English: Very rare: (may affect up to 1 in 10,000 people) • swelling in a part of the kidney that causes a reduction in its normal working function
Danish: Meget sjælden: (kan forekomme hos op til 1 ud af 10.000 personer) • hævelse i en del af nyren, hvilket nedsætter dens normale funktionsdygtighed
English: Patients with CrCL 30 to 50 mL/min received a lower dose of Zavicefta than is currently recommended for patients in this sub-group.
Danish: Patienter med CrCL 30-50 ml/min fik en lavere dosis Zavicefta, end der normalt anbefales til patienter i denne undergruppe.
English: Tell your doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
Danish: Fortæl det straks til lægen, hvis du får nogen af følgende alvorlige bivirkninger - du kan have behov for omgående lægehjælp:
English: The safety assessment in children is based on the safety data from 1 trial in which 61 paediatric patients aged from 3 years to less than 18 years with cIAI received Zavicefta.
Danish: Sikkerhedsvurderingen hos børn er baseret på sikkerhedsdata fra 1 forsøg, hvor 61 pædiatriske patienter med cIAI i alderen 3 år til under 18 år fik Zavicefta.
English: During a 4-hour haemodialysis period, 55% of the avibactam dose was removed.
Danish: Under en hæmodialyseperiode på 4 timer blev 55 % af avibactamdosen fjernet.
English: Do not use Zavicefta if:
Danish: Brug ikke Zavicefta, hvis:
English: The human protein binding of both ceftazidime and avibactam is approximately 10% and 8%, respectively.
Danish: Den humane proteinbinding af både ceftazidim og avibactam er henholdsvis ca. 10 % og 8 %.
English: Discontinuation of therapy with Zavicefta and the administration of specific treatment for Clostridium difficile should be considered.
Danish: Seponering af Zavicefta og administrationen af specifik behandling mod Clostridium difficile skal overvejes.
English: It is unknown whether avibactam is excreted in human milk.
Danish: Det er ikke kendt, om avibactam udskilles i human mælk.
English: Contains sodium carbonate - see package leaflet for further details.
Danish: Indeholder natriumcarbonat - se indlægssedlen for yderligere information.
English: • diarrhoea that keeps getting worse or does not go away, or stools that contains blood or mucus this may happen during or after treatment is stopped with Zavicefta.
Danish: • diarré, der bliver værre eller ikke går væk, eller afføring, der indeholder blod eller slim - dette kan ske under eller efter afslutning af behandlingen med Zavicefta.
English: Antibacterial activity in combination with other antibacterial agents
Danish: Antibakteriel aktivitet i kombination med andre antibakterielle midler
English: • Staphylococcus aureus (methicillin-susceptible and methicillin-reistant)
Danish: • Staphylococcus aureus (methicillin-følsom og methicillin-resistent)
English: Zavicefta will be given to you by a doctor or a nurse.
Danish: Du vil få Zavicefta af en læge eller sygeplejerske.
English: • redness, pain or swelling where Zavicefta was given into a vein
Danish: • rødme, smerter eller hævelse på det sted, hvor Zavicefta blev givet i venen
English: Additional antibacterial agents should be used when these pathogens are known or suspected to be contributing to the infectious process.
Danish: Der bør anvendes supplerende antibiotika, når disse patogener er konstateret, eller der er mistanke om, at de bidrager til infektionsprocessen.
English: Interference with laboratory tests
Danish: Interferens med laboratorieprøver
English: This is because Zavicefta is removed from your body by the kidneys.
Danish: Dette skyldes, at Zavicefta udskilles fra kroppen gennem nyrerne.
English: Pharmacotherapeutic group: Antibacterials for systemic use, ceftazidime, combinations, ATC code: J01DD52
Danish: Farmakoterapeutisk klassifikation: Antibakterielle stoffer til systemisk brug, ceftazidim, kombinationer, ATC-kode: J01DD52
English: In seven Phase 2 and Phase 3 clinical trials, 2024 adult patients were treated with Zavicefta.
Danish: I syv kliniske fase 2- og 3-studier blev 2.024 voksne patienter behandlet med Zavicefta.
English: • you are allergic to ceftazidime, avibactam or any of the other ingredients of this medicine (listed in section 6)
Danish: • du er allergisk over for ceftazidim, avibactam eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: Zavicefta is used in adults to treat:
Danish: Zavicefta anvendes til voksne til behandling af:
English: If you have too much Zavicefta it could have an effect on the brain and cause fits or coma.
Danish: Hvis du har fået for meget Zavicefta, kan det påvirke hjernen og forårsage krampeanfald eller koma.
English: In patients with renal impairment, close monitoring of estimated creatinine clearance is advised.
Danish: Hos patienter med nedsat nyrefunktion anbefales tæt monitorering af estimeret kreatininclearance.
English: No metabolism of avibactam was observed in human liver preparations (microsomes and hepatocytes).
Danish: Der blev ikke observeret nogen metabolisering af avibactam i humant levermateriale (mikrosomer og hepatocytter).
English: It is possible that this could cause anaemia (which may make you feel tired) and jaundice (yellowing of the skin and eyes)
Danish: Det er muligt, at dette kan forårsage blodmangel (som kan gøre dig træt) og gulsot (som medfører gulfarvning af hud og øjne)
English: Talk to your doctor or nurse if you suffer from diarrhoea during your treatment.
Danish: Tak med lægen eller sundhedspersonalet, hvis du lider af diarré under behandlingen.
English: Amount to be withdrawn
Danish: Mængde, der skal trækkes op
English: Clostridium difficile-associated diarrhoea
Danish: Clostridium difficile-associeret diarré
English: The most common adverse reactions occurring in ≥ 5% of patients treated with Zavicefta were Coombs direct test positive, nausea, and diarrhoea.
Danish: De hyppigste bivirkninger, der forekom hos ≥5 % af de patienter, der blev behandlet med Zavicefta, var positiv direkte Coombs test, kvalme og diarré.
English: Once removed from refrigeration to room temperature, the diluted product must be used within 12 hours.
Danish: Efter udtagning fra køleskab til stuetemperatur skal den fortyndede infusionsvæske anvendes inden for 12 timer.
English: Probenecid (a potent OAT inhibitor) inhibits this uptake by 56% to 70% in vitro and, therefore, has the potential to alter the elimination of avibactam.
Danish: Probenecid (en potent OAT-hæmmer) hæmmer denne optagelse med 56 % til 70 % in vitro og kan derfor potentielt ændre eliminationen af avibactam.
English: Clinical efficacy and safety studies of Zavicefta have been conducted in cIAI, cUTI and HAP (including VAP).
Danish: Kliniske studier af Zaviceftas virkning og sikkerhed er udført for cIAI, cUTI og HAP (herunder VAP).
English: • abnormal result with a test called “DAGT” or “Coombs”.
Danish: • unormale resultater af en test, der hedder “DAGT” eller “Coombs”.
English: • an antibiotic called chloramphenicol
Danish: • et antibiotikum kaldet chloramphenicol
English: This should be considered when administering Zavicefta to patients who are on a controlled sodium diet.
Danish: Dette bør tages i betragtning, når Zavicefta administreres til patienter, som er på diæt med kontrolleret natriumindhold.
English: The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende den første PSUR for dette præparat inden for 6 måneder efter godkendelsen.
English: 7-14 days
Danish: 7-14 dage
English: Unchanged avibactam was the major drug-related component in human plasma and urine following dosing with [
Danish: Uomdannet avibactam var den primære lægemiddelrelaterede komponent i humant plasma og urin efter dosering med [
English: In two studies in patients with cIAI, the most common diagnosis (approximately 42%) was appendiceal perforation or peri-appendiceal abscess.
Danish: I to studier med patienter med cIAI var den hyppigste diagnose (ca. 42 %) perforeret blindtarm eller periappendiceal absces.
English: This is equivalent to 22.2% of the adult recommended maximum daily dietary intake for sodium.
Danish: Dette svarer til 22,2 % af det anbefalede maksimale daglige kostindtag af natrium for voksne.
English: Following administration of avibactam throughout pregnancy and lactation in the rat, there was no effect on pup survival, growth or development, however there was an increase in incidence of dilation of the renal pelvis and ureters in less than 10% of the rat pups at maternal exposures greater than or equal to approximately 1.5 times human therapeutic exposures.
Danish: Efter administration af avibactam til rotter under drægtighed og diegivning var der ingen påvirkning af afkommets overlevelse, vækst eller udvikling, men der var en stigning i forekomsten af udvidelse af nyrebækken og ureter hos under 10 % af rotteafkommet ved maternelle eksponeringer højere end eller lig med ca. 1,5 gange den terapeutiske eksponering hos mennesker.
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: Animal studies with ceftazidime do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Danish: Dyrestudier med ceftazidim indikerer hverken direkte eller indirekte skadelige virkninger på graviditet, embryoets/fostrets udvikling, fødsel eller postnatal udvikling.
English: The chemical and physical in-use stability has been demonstrated for up to 24 hours at 2 - 8°C, followed by up to 12 hours at not more than 25
Danish: Kemisk og fysisk stabilitet under brug er demonstreret i op til 24 timer ved 2-8 °C efterfulgt af op til 12 timer ved højst 25 °C.
English: While DAGT seroconversion in patients receiving Zavicefta was very common in clinical studies (the estimated range of seroconversion across Phase 3 studies was 3.2% to 20.8% in patients with a negative Coombs test at baseline and at least one followup test), there was no evidence of haemolysis in patients who developed a positive DAGT on treatment.
Danish: Mens DAT-serokonversion hos patienter, der får Zavicefta, var meget hyppig i kliniske studier (det estimerede serokonversionsområde på tværs af fase 3-studier var 3,2 % til 20,8 % hos patienter med en negativ Coombs test ved baseline og mindst én opfølgende test), var der ingen evidens for hæmolyse hos patienter, som udviklede positiv DAT under behandlingen.
English: The total inuse stability from reconstitution to administration should not exceed 36 hours (24 hours at 2-8°C plus 12 hours room temperature).
Danish: Den samlede holdbarhed under brug fra rekonstitution til administration må ikke overstige 36 timer (24 timer ved 2-8 °C plus 12 timer ved stuetemperatur).
English: Zavicefta should not be mixed with or physically added to solutions containing other medicinal products.
Danish: Zavicefta bør ikke blandes med eller fysisk tilsættes til infusionsvæsker indeholdende andre lægemidler.
English: How Zavicefta works Zavicefta works by killing certain types of bacteria, which can cause serious infections.
Danish: Sådan virker Zavicefta Zavicefta virker ved at slå visse typer bakterier ihjel, som kan forårsage alvorlige infektioner.
English: Ceftazidime is not metabolised.
Danish: Ceftazidim metaboliseres ikke.
English: Medicinal products that inhibit peristalsis should not be given.
Danish: Der må ikke gives lægemidler, der hæmmer peristaltikken.
English: Talk to your pharmacist or doctor if you have been advised to have a low salt diet.
Danish: Kontakt lægen eller apotekspersonalet, hvis du er blevet rådet til at spise en saltfattig kost.
English: The maximum daily dose of this product is equivalent to 22.2% of the WHO recommended maximum daily intake for sodium.
Danish: Den maksimale daglige dosis af dette produkt svarer til 22,2 % af det af WHO anbefalede maksimale daglige indtag af natrium.
English: Mix gently to reconstitute and check to see that the contents have dissolved completely.
Danish: Bland forsigtigt for at rekonstituere og kontroller, at pulveret er fuldstændig opløst.
English: The compatibility of Zavicefta with other medicines has not been established.
Danish: Zaviceftas forligelighed med andre lægemidler er ikke blevet klarlagt.
English: Frequency Infusion time
Danish: Hyppighed Infusionstid
English: Do not use Zavicefta if any of the above apply to you.
Danish: Du må ikke bruge Zavicefta, hvis noget af ovenstående gælder for dig.
English: Minimum Inhibitory Concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) for ceftazidime/avibactam are as follows: Organisms
Danish: Grænseværdierne for mindste hæmmende koncentration (MIC), som er fastlagt af European Committee on Antimicrobial Susceptibility Testing (EUCAST) for ceftazidim/avibactam, er følgende: Organismer
English: • Anaerobes
Danish: • Anaerober
English: 5-14 days
Danish: 5-14 dage
English: 2 hours Guided by the severity of the infection, the pathogen(s) and the patient's clinical and bacteriological progress
Danish: Hver 8. time 2 timer Bestemmes efter sværhedsgraden af infektionen, patogenet/patogenerne og patientens kliniske og bakteriologiske fremskridt
English: Reduced clearance of ceftazidime was observed in elderly patients, which was primarily due to agerelated decrease in renal clearance of ceftazidime.
Danish: Der blev observeret reduceret clearance af ceftazidim hos ældre patienter, hvilket primært skyldes et aldersrelateret fald i den renale clearance af ceftazidim.
English: In vitro, avibactam is a substrate of OAT1 and OAT3 transporters which might contribute to the active uptake of avibactam from the blood compartment and therefore affect its excretion.
Danish: In vitro er avibactam substrat for OAT1- og OAT3-transportører, som kan bidrage til den aktive optagelse af avibactam fra blodfordelingsrummet og derfor påvirke dets udskillelse.
English: Approximately 87% of patients had APACHE II scores of ≤ 10 and 4.0% had bacteraemia at baseline.
Danish: Ca. 87 % af patienterne havde APACHE II-score ≤ 10, og 4,0 % havde bakteriæmi ved baseline.
English: Transfer the entire contents (approximately 12.0 mL) of the resultant solution to an infusion bag immediately.
Danish: Overfør straks alt indholdet (ca. 12,0 ml) af den resulterende opløsning til en infusionspose .
English: Withdraw the needle and shake the vial to give a clear solution.
Danish: Træk kanylen ud og ryst hætteglasset for at få en klar opløsning.
English: Ceftazidime concentrations of 4 to 20 mg/L or more are achieved in the CSF when the meninges are inflamed.
Danish: Ceftazidimkoncentrationer på 4-20 mg/l eller højere opnås imidlertid i CSF ved inflammerede meninges.
English: Avibactam penetration of the blood brain barrier has not been studied clinically; however, in rabbits with inflamed meninges, CSF exposures of ceftazidime and avibactam were 43% and 38% of plasma AUC, respectively.
Danish: Penetration af avibactam ind i blod-hjerne-barrieren er ikke undersøgt klinisk, men hos kaniner med inflammerede meninges var CSF-eksponeringen af ceftazidim og avibactam henholdsvis 43 % og 38 % af plasma-AUC.
English: Neurological sequelae, including tremor, myoclonus, non-convulsive status epilepticus, convulsion, encephalopathy and coma, have occasionally been reported with ceftazidime when the dose has not been reduced in patients with renal impairment.
Danish: Neurologiske sequelae, herunder tremor, myoclonus, ikke-konvulsiv status epilepticus, kramper, encefalopati og koma, er sommetider rapporteret for ceftazidim, når dosis ikke er blevet reduceret hos patienter med nedsat nyrefunktion.
English: Volume of diluent to be added (mL)
Danish: Mængde af solvens, der skal tilsættes (ml)
English: Avibactam and ceftazidime do not inhibit the major renal or hepatic transporters in the clinically relevant exposure range, therefore the interaction potential via these mechanisms is considered to be low.
Danish: Avibactam og ceftazidim hæmmer ikke de vigtigste renale og hepatiske transportører i det klinisk relevante eksponeringsinterval, og derfor anses interaktionspotentialet via disse mekanismer for at være lavt.
English: After reconstitution
Danish: Efter rekonstitution
English: Complicated UTI, including pyelonephritis
Danish: Kompliceret UTI, herunder pyelonefritis
English: Each vial contains a total of 6.44 mmol of sodium (approximately 148 mg), equivalent to 7.4% of the WHO recommended maximum daily intake for sodium.
Danish: Hvert hætteglas indeholder i alt 6,44 mmol natrium (ca. 148 mg), svarende til 7,4 % af det af WHO anbefalede maksimale daglige indtag af natrium.
English: • severe allergic reactions - signs include sudden swelling of your lips, face, throat or tongue, a severe rash or other severe skin reactions, difficulty swallowing or breathing.
Danish: • alvorlige allergiske reaktioner - tegnene omfatter pludselig hævelse af læber, ansigt, svælg eller tunge, udbredt udslæt eller andre alvorlige hudreaktioner samt synkebesvær eller vejrtrækningsbesvær.
English: Ask your pharmacist how to throw away medicines you no longer require.
Danish: Spørg på apoteket, hvordan du skal bortskaffe medicinrester.
English: Pfizer Ireland Pharmaceuticals Operations Support Group Ringaskiddy, County Cork Ireland
Danish: Pfizer Ireland Pharmaceuticals Operations Support Group Ringaskiddy, County Cork Irland
English: • Complicated intra-abdominal infection (cIAI)
Danish: • Kompliceret intra-abdominal infektion (cIAI)
English: • Avibactam is a “beta-lactamase inhibitor” that helps ceftazidime kill some bacteria that it cannot kill on its own.
Danish: • Avibactam er en beta-laktamasehæmmer, der hjælper ceftazidim med at slå nogle bakterier ihjel, som det ikke selv kan slå ihjel.
English: A 100 mL infusion bag can be used to prepare the infusion, based on the patient's volume requirements.
Danish: Der kan anvendes en 100 ml infusionspose til at fremstille infusionsvæsken, alt efter patientens volumenbehov.
English: Lab tests
Danish: Laboratorieprøver
English: For instructions on reconstitution and dilution of the medicinal product before administration see section 6.6.
Danish: For instruktioner om rekonstitution og fortynding af lægemidlet før administration, se pkt.
English: Ceftazidime is excreted in human milk in small quantities.
Danish: Ceftazidim udskilles i små mængder i human mælk.
English: Serious and occasionally fatal hypersensitivity reactions are possible (see sections 4.3 and 4.8).
Danish: Alvorlige og til tider dødelige overfølsomhedsreaktioner kan forekomme (se pkt.
English: Following a single intravenous administration of 500 mg avibactam as a 30-minute IV infusion, the elderly had a slower terminal half-life of avibactam, which may be attributed to age related decrease in renal clearance.
Danish: Efter en enkelt administration af 500 mg avibactam som en 30-minutters i.v.-infusion var avibactams terminale halveringstid længere hos de ældre, hvilket kan skyldes en aldersrelateret reduktion af den renale clearance.
English: This could cause symptoms such as fits (see section If you use more
Danish: Dette ville kunne give dig symptomer såsom krampeanfald (se afsnittet Hvis du har fået for meget Zavicefta)
English: The terminal half-life (t½) of both ceftazidime and avibactam is about 2 h after intravenous administration.
Danish: Den terminale halveringstid (t½) for både ceftazidim og avibactam er ca. 2 timer efter intravenøs administration.
English: In case of hypersensitivity reactions, treatment with Zavicefta must be discontinued immediately and adequate emergency measures must be initiated.
Danish: I tilfælde af overfølsomhedsreaktion skal Zavicefta straks seponeres, og der skal tages tilstrækkelige forholdsregler for så vidt angår førstehjælp.
English: However, the possibility that haemolytic anaemia could occur in association with Zavicefta treatment cannot be ruled out.
Danish: Risikoen for, at der kan opstå hæmolytisk anæmi i forbindelse med behandling med Zavicefta, kan imidlertid ikke udelukkes.
English: Studies have shown that Zavicefta solutions for infusion are stable for up to 12 hours at room temperature.
Danish: Studier har vist, at Zavicefta-infusionsvæske er holdbar i op til 12 timer ved stuetemperatur.
English: Both ceftazidime and avibactam penetrate into human bronchial epithelial lining fluid (ELF) to the same extent with concentrations around 30% of those in plasma.
Danish: Både ceftazidim og avibactam penetrerer ind i epitelvæsken (epithelial lining fluid - ELF) i bronkierne hos mennesker i samme udstrækning med koncentrationer på ca. 30 % af plasmakoncentrationen.
English: Note: to preserve product sterility, it is important that the gas relief needle is not inserted through the vial closure before the product is dissolved.
Danish: Bemærk: For at bibeholde præparatets sterilitet er det vigtigt, at gasudligningskanylen ikke indsættes gennem hætteglassets prop, før produktet er opløst.
English: A total of 81 cUTI patients (7.4%) had bacteraemia at baseline.
Danish: I alt 81 cUTI-patienter (7,4 %) havde bakteriæmi ved baseline.
English: Marketing Authorisation Holder Pfizer Ireland Pharmaceuticals Operations Support Group Ringaskiddy, County Cork Ireland
Danish: Indehaver af markedsføringstilladelsen Pfizer Ireland Pharmaceuticals Operations Support Group Ringaskiddy, County Cork Irland
English: Hospital-acquired pneumonia, including ventilator-associated pneumonia In a single study in patients with nosocomial pneumonia 280/808 (34.7%) had VAP and 40/808 (5.0%) were bacteraemic at baseline.
Danish: Nosokomiel pneumoni, herunder respiratorassocieret pneumoni I et enkelt studie med patienter med nosokomiel pneumoni havde 280/808 (34,7 %) VAP, og 40/808 (5,0 %) var bakteriæmiske ved baseline.
English: Undesirable effects may occur (e.g. dizziness), which may influence the ability to drive and use machines following administration of Zavicefta (see section 4.8).
Danish: Der kan forekomme bivirkninger (fx svimmelhed), som kan påvirke evnen til at føre motorkøretøj og betjene maskiner efter administration af Zavicefta (se pkt.
English: 20 mL glass vial (Type 1) closed with a rubber (halobutyl) stopper and aluminium seal with flip-off cap.
Danish: 20 ml hætteglas (type 1-glas) lukket med en gummiprop (halobutyl) og aluminiumforsegling med en flip-off-hætte.
English: • a type of antibiotic called an aminoglycoside - such as gentamicin, tobramycin
Danish: • en type antibiotikum kaldet et aminoglykosid, såsom gentamicin, tobramycin
English: The effects of ceftazidime/avibactam on fertility in humans have not been studied.
Danish: Indvirkningen af ceftazidim/avibactam på fertiliteten hos mennesker er ikke undersøgt.
English: In pregnant rabbits administered avibactam at 300 and 1000 mg/kg/day, there was a dose-related lower mean foetal weight and delayed ossification, potentially related to maternal toxicity.
Danish: Hos drægtige kaniner, som fik avibactam i doser på 300 og 1000 mg/kg dagligt, var der en dosisrelateret lavere gennemsnitlig fostervægt og forsinket ossifikation, der potentielt var relateret til maternel toksicitet.
English: Tell the person taking the sample that you have been given Zavicefta.
Danish: Fortæl det til den person, der tager prøven, at du har fået Zavicefta.
English: Do not insert a gas relief needle until the product has dissolved.
Danish: Indsæt ikke en gasudligningskanyle, før produktet er opløst.
English: Ceftazidime may interfere with copper reduction methods (Benedict's, Fehling's, Clinitest) for detection of glycosuria leading to false positive results.
Danish: Ceftazidim kan interferere med kobberreduktionsmetoder (Benedicts, Fehlings, Clinitest) til påvisning af glukosuri, medførende falsk positive resultater.
English: The medicinal product is supplied in packs of 10 vials.
Danish: Lægemidlet leveres i pakninger med 10 hætteglas.