FrancophonIA/ELRC3.0 huggingface dataset:
English: This means that when piperacillin and tazobactam are given together, more types of bacteria are killed.
Danish: Det betyder, at når piperacillin og flere typer af bakterier slået ihjel.
English: Piperacillin is metabolised to a minor microbiologically active desethyl metabolite.
Danish: Piperacillin metaboliseres til en mindre mikrobiologisk aktiv desetylmetabolit.
English: Swirl until dissolved.
Danish: Omrystes, indtil pulveret er opløst.
English: Adult and adolescent patients
Danish: Voksne og unge patienter
English: Edetate disodium (EDTA)
Danish: Dinatriumedetat (EDTA)
English: Children aged 2 to 12 years
Danish: Børn i alderen 2-12
English: Porphyromonas species
Danish: Porphyromonas-arter
English: Non-depolarising muscle relaxants
Danish: Ikke-depolariserende muskelrelaksantia
English: This regimen may also be applicable to treat patients with other indicated infections when particularly severe.
Danish: Denne dosering kan også anvendes til at behandle ed andre indicerede infektioner, når disse er særligt svære.
English: In the following table, adverse reactions are listed by system organ class and MedDRA-preferred term.
Danish: tabel opstilles de nde ser efter systemorganklasse og foretrukken term i henhold RA.
English: Distribution into cerebrospinal fluid is low in subjects with non-inflamed meninges, as with other penicillins.
Danish: Fordelingen i cerebrospinalvæsken er lav hos forsøgspersoner med ikke-betændte meninges, som ved andre penicilliner.
English: If you are pregnant, think you may be pregnant or are trying to become pregnant, tell your doctor or other healthcare professional before receiving this product.
Danish: Hvis du er gravid, hvis du tror, at du måske er gravid, eller hvis du planlægger at blive det, skal du fortælle det til din læge eller en anden sundhedsfaglig person, inden du får dette lægemiddel.
English: If you are breastfeeding, your doctor will decide if TAZOCIN is right for you.
Danish: Hvis du ammer, vil din læge beslutte, om TAZOCIN er godt for dig.
English: Intravenous use
Danish: Intravenøs anvend
English: Driving and using machines The use of TAZOCIN is not expected to affect the ability to drive or use machines.
Danish: Brugen af TAZOCIN forventes ikke at påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: Cross-reactions with non-Aspergillus polysaccharides and polyfuranoses with Bio-Rad Laboratories Platelia Aspergillus EIA test have been reported.
Danish: Der er rapporteret om krydsreaktioner mellem ikke-Aspergilluspolysaccharider og polyfuranoser og Bio-Rad Laboratories' Platelia Aspergillus-EIA-test.
English: The safety and efficacy of Tazocin in children 0- 2 years of age has not been established.
Danish: kerhed og virkning hos børn i alderen 0-2 år er ikke klarlagt.
English: In these cases Tazocin, should be discontinued.
Danish: I sådanne tilfælde bør Tazocin seponeres.
English: medicines containing the other antibiotics tobramycin or gentamycin.
Danish: ladningen, eller ndeholder de andre antibiotika tobramycin eller gentamicin.
English: Packs containing 1, 5, 10, 12 or 25 vials.
Danish: Pakningsstørrelser er 1, 5, 10, 12 eller 25 hætteglas.
English: Tazobactam is metabolised to a single metabolite that has been found to be microbiologically inactive.
Danish: Tazobactam metaboliseres til en enkelt metabolit, der har vist sig at være mikrobiologisk inaktiv.
English: The time above the minimum inhibitory concentration (T>MIC) is considered to be the major pharmacodynamic determinant of efficacy for piperacillin.
Danish: Tiden over den minimumshæmmende koncentration (T>MIC) anses for at være farm akodynamiske determinant for piperacillins virkning.
English: Peptostreptococcus species
Danish: Peptostreptococcus-arter
English: Piperacillin and tazobactam can increase the time it takes for methotrexate to leave your body.
Danish: Piperacillin / m kan øge den tid, det tager for methotrexat at forlade din krop.
English: Your doctor will calculate the dose depending on your child's weight but the daily dose will not exceed 4 g / 0.5 g of TAZOCIN.
Danish: Din læge beregner dosis ud fra dit barns vægt, men den daglige dosis vil ikke overstig TAZOCIN.
English: When reconstituted as directed, the vial contents withdrawn by syringe will provide the labelled amount of piperacillin and tazobactam.
Danish: Når rekonstitueringen er gennemført som beskrevet, vil det udtrukne indhold i sprøjten indeholde den mærkede mængde piperacillin og tazobactam.
English: Eubacterium species
Danish: Eubacterium-arter
English: Immune system disorders hypersensitivity anaphylactic/ anaphylactoid reaction (including shock)
Danish: Immunsystemet overfølsomhed anafylaktisk/ anafylaktoid reaktion (herunder shock)
English: This leaflet was last approved in {MM/YYYY}.
Danish: dfyldes nationalt] Denne indlægsseddel blev senest godkendt {MM/ÅÅÅÅ}.
English: £ All methicillin-resistant staphylococci are resistant to piperacillin / tazobactam.
Danish: Alle methicillinresistente staphylococci er resistente for piperacillin / tazobactam
English: Detailed information on this medicine is available on the website:
Danish: [Udfyldes nationalt] Yderligere information om dette lægemiddel er tilgængelig på:
English: These reactions are more likely to occur in persons with a history of sensitivity to multiple allergens.
Danish: Der er større risiko for forekommer hos personer, der tidligere har vist overfølsomhed over for flere allergener.
English: Citric acid monohydrate
Danish: Citronsyre, monohydrat
English: Rare ≥ 1/10,000 to
Danish: Sjælden 1/10.000 til
English: The susceptibility of streptococci is inferred from the penicillin susceptibility.
Danish: Følsomheden for streptococci udledes ud fra penicillinfølsomheden.
English: Discard any unused solution.
Danish: Kassér eventuelt ubrugt opløsning.
English: Fusobacterium species
Danish: Fusobacterium-arter
English: There have been post-marketing reports of overdose with piperacillin / tazobactam.
Danish: Der er efter markedsføring rapporteret om overdosering med piperacillin / tazobactam.
English: No dose adjustment necessary Maximum dose suggested: 4 g / 0.5 g every 8 hours Maximum dose suggested: 4 g / 0.5 g every 12 hours
Danish: Dosisjustering er ikke nødvendig Foreslået maksimumsdosis: 4 g/0,5 g hver 8. time Foreslået maksimumsdosis: 4 g/0,5 g hver 12. time
English: Infections and infestations candidal superinfection
Danish: Infektioner og parasitære sygdomme candidi asissuperinfektion
English: Piperacillin therapy has been associated with an increased incidence of fever and rash in cystic fibrosis patients.
Danish: Piperacillinbehandling er blevet forbundet med en øget forekomst af feber og udslæt hos patienter med cystisk fibrose.
English: 10 ml
Danish: 2 g
English: For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.
Danish: C. Opbevaringsforhold for det rekonstituerede og fortyndede lægemiddel, se pkt.
English: • Inactivation of the piperacillin component by those beta-lactamases that are not inhibited by tazobactam: beta-lactamases in the Molecular class B, C and D. In addition, tazobactam does not provide protection against extended-spectrum beta-lactamases (ESBLs) in the Molecular class A and D enzyme groups.
Danish: • Inaktivering af piperacillinkomponenten gennem de betalaktamaser, der ikke hæmmes af tazobactam: betalaktamaser i molekylærklasse B, C og D. Derudover yder tazobactam ikke beskyttelse mod betalaktamaser med udvidet spektrum i molekylærklasse A- og D-enzymgrupperne.
English: Unopened vials: Do not store above 25°C.
Danish: Uåbnede hætteglas: Må ikke opbevares ved temperaturer over 25 °C.
English: The pharmacokinetics of piperacillin, tazobactam, and the M1 metabolite were also not significantly altered by tobramycin administration.
Danish: Farmakokinetikken for piperacillin, tazobactam og M1-metabolitten blev heller ikke ndret ved administration af tobramycin.
English: During simultaneous administration of heparin, oral anticoagulants and other substances that may affect the blood coagulation system including thrombocyte function, appropriate coagulation tests should be performed more frequently and monitored regularly.
Danish: rende midler og andre stoffer, der kan have ing på blodets koagulationssystem, herunder trombocytfunktion, skal de relevante koagulationstest foretages hyppigere og kontrolleres regelmæssigt.
English: Do not use TAZOCIN after the expiry date which is stated on the carton and vial after “EXP”.
Danish: Brug ikke TAZOCIN efter den udløbsdato, der står på pakningen.
English: Tazocin should not be added to blood products or albumin hydrolysates.
Danish: TAZOCIN bør ikke tilsættes til blodprodukter eller albumin-hydrolysater.
English: Protein measurement with dip sticks is not affected.
Danish: Bestemmelse af protein med dipstick er ikke berørt.
English: Aerobic Gram-negative micro-organisms Citrobacter koseri
Danish: Aerobe gramnegative mikroorganismer Citrobacter koseri
English: A number of chemical urine protein measurement methods may lead to false-positive results.
Danish: der til bestemmelse af urinprotein kan give falsk-positive resultater.
English: What TAZOCIN contains
Danish: TAZOCIN indeholder:
English: EUCAST Clinical MIC Breakpoints for Piperacillin / Tazobactam (2009-12-02, v 1).
Danish: Grænseværdier STs kliniske llin / tazobactam (2009-12-02,
English: It can kill many kinds of bacteria.
Danish: Det er antibiotika, der kan slå mange forskellige bakterier ihjel.
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinjer.
English: No specific antidote is known.
Danish: specifik antidot.
English: Metabolism and nutrition disorders hypokalaemia, blood glucose decreased, blood albumin decreased, blood protein total decreased
Danish: Metabolisme og ernæring hypokaliæmi, sænket blodglucose, sænket blodalbumin, sænket totalprotein i blodet
English: if you are allergic (hypersensitive) to antibiotics known as penicillins, cephalosporins or other beta-lactamase inhibitors, as you may be allergic to TAZOCIN.
Danish: hvis du er overfølsom (allergisk) over for antibiotika kendt som penicilliner, cefalosporiner eller andre betalaktamase-hæmmere, da du kan være overfølsom over for TAZOCIN.
English: Non-enzymatic methods of measuring urinary glucose may lead to false-positive results, as with other penicillins.
Danish: Ikke-enzymatiske metoder til måling af glucose i urinen kan medføre falsk-positive r andre penicilliner.
English: For patients on haemodialysis, one additional dose of piperacillin / tazobactam 2 g / 0.25 g should be administered following each dialysis period, because haemodialysis removes 30%-50% of piperacillin in 4 hours.
Danish: Patienter i hæmodialyse bør få én yderligere dosis piperacillin / tazobactam 2 g/0,25 g efter hver dialyseperiode, da hæmodialysen fjerner 30-50 % piperacillin i løbet af 4 timer.
English: As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
Danish: Råd fra eksperter år den lokale prævalens af resistens er af en sådan karakter, at nytten af ektionstyperne er tvivlsom.
English: Carcinogenicity studies have not been conducted with piperacillin / tazobactam.
Danish: Der er ikke udført undersøgelser af karcinogeniciteten for piperacillin / tazobactam.
English: Streptococcus pneumonia Streptococcus viridans group Aerobic Gram-negative micro-organisms Acinetobacter baumannii$
Danish: Streptococcus pneumonia Streptococcus viridans-gruppen Aerobe gramnegative mikroorganismer Acinetobacter baumannii$
English: Following single or multiple doses of piperacillin / tazobactam to healthy subjects, the plasma half-life of piperacillin and tazobactam ranged from 0.7 to 1.2 hours and was unaffected by dose or duration of infusion.
Danish: Efter indgift af en eller fle plasmahalveringstiden for piperacillin og tazobactam fra 0,7 til 1,2 timer, og den var i hverken dosis eller infusionsvarighed
English: Pharmacotherapeutic group: Antibacterials for systemic use, Combinations of penicillins incl.
Danish: Farmakoterapeutisk klassifikation: Antibakterielle midler til systemisk brug, Kombin penicilliner, inkl.
English: The other ingredients are citric acid monohydrate and edetate disodium (EDTA).
Danish: Øvrige indholdsstoffer: citronsyremonohydrat og dinatriumedetat (EDTA).
English: Read all of this leaflet carefully before you start using this medicine.
Danish: Piperacill Læs denne indlægsseddel grundigt, inden du begynder at bruge medicinen.
English: Therapy with Tazocin may result in the emergence of resistant organisms, which might cause superinfections.
Danish: Behandling med Tazocin kan medføre fremkomst af resistente organismer, der kan sk
English: Mycoplasma pneumonia $ Species showing natural intermediate susceptibility.
Danish: Andre mikroorganismer Chlamydophilia pneumonia Mycoplasma pneumonia $ Arter, der fremviser naturlig intermediær følsomhed.
English: Piperacillin belongs to the group of medicines known as “broad-spectrum penicillin antibiotics”.
Danish: VIRKNING OG ANVENDELSE Piperacillin hører til en gruppe lægemidler, der kaldes ”bredspektrede penicilliner”.
English: Common ≥ 1/100 to
Danish: Almin ≥ 1/100 til e a
English: The susceptibility of staphylococci is inferred from the oxacillin susceptibility.
Danish: Følsomheden for staphylococci udledes ud fra oxacillinfølsomheden.
English: The selection of piperacillin / tazobactam to treat an individual patient should take into account the appropriateness of using a broad-spectrum semi-synthetic penicillin based on factors such as the severity of the infection and the prevalence of resistance to other suitable antibacterial agents.
Danish: Ved valget af piperacillin / tazobactam til behandling af den enkelte patient bø en bredspektret, semisyntetisk penicillin overvejes ud fra infektionens sværhedsgrad o resistens over for andre relevante antibakterielle stoffer.
English: Due to chemical instability, Tazocin should not be used in solutions containing only sodium bicarbonate.
Danish: På grund af kemisk ustabilitet bør Tazocin ikke anvendes i opløsninger, der kun indeholder
English: In the event of an overdose, piperacillin / tazobactam treatment should be discontinued.
Danish: Behandling I tilfælde af en overdosis bør behandling med piperacillin / tazobactam seponeres.
English: Antibiotic-induced pseudomembranous colitis may be manifested by severe, persistent diarrhoea which may be life-threatening.
Danish: Pseudomembranøs colitis fremkaldt af antibiotika kan manifestere sig som alvor som kan være livstruende.
English: Some medicines may interact with piperacillin and tazobactam.
Danish: Nogle læ interagere med piperacillin og tazobactam.
English: Tazocin 4 g / 0.5 g Severe pneumonia
Danish: Tazocin 4 g/0,5 g Svær lungebetændelse
English: For single use only.
Danish: Kun til engangsbr
English: Summary of product characteristics, labelling and package leaflet
Danish: Produktresumé, mærkning og indlægsseddel
English: Anaerobic Gram-negative micro-organisms Bacteroides fragilis group
Danish: Anaerobe gramnegative mikroorganismer Bacteroides fragilis-gruppen
English: If bleeding manifestations occur, the antibiotic should be discontinued and appropriate therapy instituted.
Danish: Hvis blødningsmanifestationer opstår, bør antibiotikummet seponeres og passende behan funktion vurderes regelmæssigt.
English: If you have several allergies, make sure you tell your doctor or other healthcare professional before receiving this product.
Danish: Hvis du har flere allergier, skal du huske at sige det til l sundhedsfaglig person, inden du får dette lægemiddel.
English: For children on haemodialysis, one additional dose of 40 mg piperacillin / 5 mg tazobactam / kg should be administered following each dialysis period.
Danish: Børn i hæmodialyse bør få én yderligere dosis på 40 mg piperacillin / 5 mg tazobactam/kg efter hver dialyseperiode.
English: The reconstituted solutions may be further diluted to the desired volume (e.g. 50 ml to 150 ml) with one of the following compatible solvents:
Danish: Den rekonstituerede opløsning kan yderligere fortyndes til den ønskede mængde (f.eks. 50 ml til 150 ml)
English: Studies in animals have shown developmental toxicity, but no evidence of teratogenicity, at doses that are maternally toxic (see section 5.3).
Danish: Dyreforsøg har påvist udviklingstoksicitet, men ingen tegn på teratogenicitet ved dos moderdyrene (se pkt.
English: Fertility of the F1 generation and embryonic development of F2 generation were not impaired.
Danish: F1-generationens fertilitet og F2-generationens embryonale udvikling var ikke ion af tazobactam eller svægt hos rotter ved
English: The half-life of piperacillin and of tazobactam increases by approximately 25% and 18%, respectively, in patients with hepatic cirrhosis compared to healthy subjects.
Danish: Halveringstiden for piperacillin og tazobactam stiger med henholdsvis ca. 25 % og 18 % hos med levercirrose sammenlignet med raske forsøgspersoner.
English: Staphylococcus species, coagulase negative, methicillin-susceptible Streptococcus pyogenes
Danish: Staphylococcus-arter, koagulasenegativ, methicillinfølsom Streptococcus pyogenes
English: After reconstitution, chemical and physical in-use stability of diluted infusion solutions has been demonstrated for 24 hours at 25°C and for 48 hours when stored in a refrigerator at 2-8°C, when reconstituted using one of the compatible solvents for further dilution of the reconstituted solution at the suggested dilution volumes (see section 6.6).
Danish: Efter rekonstituering er kemisk stabilitet og fysisk brugsstabilitet for fortyndede opløsninger til infusionsvæske påvist i op til 24 timer ved 25 °C og i op til 48 timer ved opbevaring i et køleskab ved 28 °C efter rekonstituering med en af de forligelige opløsninger til yderligere fortynding af den rekonstituerede opløsning ved de foreslåede fortyndingsvolumener (se pkt.
English: Piperacillin is excreted in low concentrations in human milk; tazobactam concentrations in human milk have not been studied.
Danish: cillin udskilles i lav koncentration i human mælk; tazobactam-koncentrationer i human mælk er fordel for kvinden
English: However, amikacin and gentamicin were determined to be compatible with TAZOCIN in vitro in certain diluents at specific concentrations (see Coadministration of TAZOCIN with aminoglycosides below).
Danish: Amikacin og gentamicin har dog vist sig at være forligelige med TAZOCIN in vitro i visse fortyndingsmidler ved specifikke koncentrationer (se Samtidig indgift af TAZ
English: The following information is intended for medical or healthcare professionals only:
Danish: Følgende oplysninger er tiltænkt læger og sundhedspersonale: Brugervejledni
English: The peak piperacillin and tazobactam concentrations after 4 g / 0.5 g administered over 30 minutes by intravenous infusion are 298 µg/ml and 34 µg/ml respectively.
Danish: De højeste piperacillin- og tazobactam-koncentrationer, der er set efter 4 g/0,5 g in ved intravenøs infusion, er hhv. 298 µg/ml og 34 µg/ml.
English: Your doctor may want to check your kidneys before you take this medicine and may perform regular blood tests during treatment.
Danish: Din læge vil måske tjekke din nyrefunktion, inden du tager dette lægemiddel, og kan tage regelmæssige blod behandlingen.
English: LIST OF EXCIPIENTS Edetate disodium (EDTA) and citric acid monohydrate.
Danish: LISTE OVER HJÆLPESTOFFER Dinatriumedetat (EDTA) og citronsyremonohydrat.
English: In a population PK analysis, estimated clearance for 9 month-old to 12 year-old patients was comparable to adults, with a population mean (SE) value of 5.64 (0.34) ml/min/kg.
Danish: r på 9 måneder-12 år ig med clearance hos voksne, og den gennemsnitlige værdi for populationen (SE) var 5,64 34) ml/min/kg.
English: 0.9% sodium chloride or 5% glucose * The dose of aminoglycoside should be based on patient weight, status of infection (serious or life-threatening) and renal function (creatinine clearance).
Danish: 2 g/0,25 g 4 g/0,5 g natriumchlorid eller 5 % glucose * Aminoglykosiddosen bør baseres på patientens vægt, infektionsstatus (alvorlig eller livstruende) og nyrefunktion (kreatininclearance).
English: Protein binding of the tazobactam metabolite is negligible.
Danish: Tazobactam-metabolittens proteinbinding er ubetydelig.
English: Compatibility of TAZOCIN with other aminoglycosides has not been established.
Danish: Forligeligheden af Tazocin med andre aminoglykosider er ikke blevet fastlagt.
English: Haemodialysis removes 30% to 50% of piperacillin / tazobactam, with an additional 5% of the tazobactam dose removed as the tazobactam metabolite.
Danish: Hæmodialyse fjerner 30-50 % af piperacillin / tazobactam, og yderligere 5 % af tazo som tazobactam-metabolit.
English: 100 mg Piperacillin / 12.5 mg Tazobactam per kg body weight / every 8 hours
Danish: 100 mg piperacillin / 12,5 mg tazobactam pr. kg legemsvægt/hver 8. time
English: In certain serious infections, your doctor may consider using TAZOCIN in combination with other antibiotics.
Danish: TAZOCIN kan anvendes til enter med lav Ved visse alvorlige infektioner kan lægen overveje at bruge TAZOCIN sammen med andre antibiotika.
English: In this case, you should inform your doctor or other healthcare professional.
Danish: I så tilfælde bør du sige det til lægen eller en anden sundhedsfaglig person.
English: No dose adjustment is necessary (see section 5.2).
Danish: Nedsat leverfunktion Dosisjustering er ikke nødvendig (se pkt.
English: methotrexate (medicine used to treat cancer, arthritis or psoriasis).
Danish: Fortæl det til lægen, hvis du skal iddel, der bruges til at behandle kræft, artritis eller psoriasis).
English: medicines that reduce the level of potassium in your blood (e.g. tablets enhancing urination or some medicines for cancer).
Danish: methotrexat (et lægem tazobacta lægemidler, der reducerer kaliumniveauet i blodet (f.eks. tabletter, der øger vand visse lægemidler mod kræft).
English: The elimination half-lives of both piperacillin and tazobactam are increased with decreasing renal clearance.
Danish: Eliminationshalveringstiden for både piperacillin og tazobactam øges ved nedsat renal clearance.
English: Anaerobic Gram-positive micro-organisms Clostridium species
Danish: Anaerobe grampositive mikroorganismer Clostridium-arter
English: This should be taken into consideration if you are on a controlled-sodium diet.
Danish: Dette bør tages med i overvejelserne h kontrolleret natriumdiæt.
English: Tazocin 2 g / 0.25 g is administered by intravenous infusion (over 30 minutes).
Danish: Tazocin 2 g/0,25 g indgives ved intravenøs infusion (over 30 minutter).
English: No pharmacokinetic interactions have been noted between piperacillin / tazobactam and vancomycin.
Danish: Der er ikke observeret nogen farmakokinetiske interaktioner mellem piperacil vancomycin.
English: As with treatment with other penicillins, neurological complications in the form of convulsions may occur when high doses are administered, especially in patients with impaired renal function.
Danish: Ligesom ved behandling med andre penicilliner kramper, når høje doser indgives, især hos patienter med nedsat
English: Tazocin may be used in the management of neutropenic patients with fever suspected to be due to a bacterial infection.
Danish: Tazocin kan anvendes til behandling af neutropeniske patienter med feber, der mistænkes at være forårsaget af en bakterieinfektion.
English: Common side effects: diarrhoea, vomiting, nausea skin rashes
Danish: Almindelige bivirkninger: diarré, opka hududslæt
English: When swirled constantly, reconstitution generally occurs within 5 to 10 minutes (for details on handling, please see below).
Danish: Ved ngen typisk inden for 5-10 minutter (oplysninger vedrørende håndtering
English: Prevotella species
Danish: Prevotella-arter
English: Tazobactum extends the antibiotic spectrum of piperacillin to include many beta-lactamase-producing bacteria that have acquired resistance to piperacillin alone.
Danish: Tazobactam udvider piperacillins antibiotiske å at omfatte mange betalaktamaseproducerende bakterier, der er blevet resistente over for e.