FrancophonIA/ELRC3.0 huggingface dataset:
English: Ringer's acetate/malate
Danish: Ringer-acetat Ringer-acetat/malat
English: Skin and soft tissue infections (including diabetic foot infections)
Danish: Komplicerede intraabdominale infektioner Hud/bløddelsinfektioner (herunder diabetiske fodinfektioner)
English: Nervous system disorders headache, insomnia
Danish: Nervesystemet hovedpine, insom i n
English: Piperacillin / tazobactam is widely distributed in tissues and body fluids including intestinal mucosa, gallbladder, lung, bile, and bone.
Danish: Piperacillin / tazobactam fordeles i stor udstrækning i væv og kropsvæsker, herunder tarmslimhinder, galdeblære, lunger, galde og knogler.
English: if you think you developed a new or worsening infection.
Danish: hvis du sundhedsfagli hvis du tror, at du har fået en ny infektion, eller en eksisterende infektion er bl
English: 0.9% (9 mg/ml) sodium chloride solution for injection Sterile water for injections(1)
Danish: 0,9 % (9 mg/ml) natriumchlorid-injektionsvæske, opløsning Sterilt vand til injektionsv (1)
English: Leukopenia and neutropenia may occur, especially during prolonged therapy; therefore, periodic assessment of haematopoietic function should be performed.
Danish: Leukopeni og neutropeni kan forekomme, især ved langvarig behandling; derfor bør den hæmatopoietiske kan der opstå neurologiske komplikationer i form af nyrefunktion.
English: Due to their similar mechanisms of action, it is expected that the neuromuscular blockade produced by any of the non-depolarising muscle relaxants could be prolonged in the presence of piperacillin.
Danish: neuromuskulære blokade, der forårsages af de ikke-depolariserende muskelrelaksantia, vil kunne blive deværelsen af piperacillin.
English: Your doctor may also want to test your blood to make sure that your treatment is at the right dose, especially if you have to take this medicine for a long time.
Danish: Din læge kan også teste dit blod for at sikre, at du bliver behandlet med den rette d taget lægemidlet
English: [See Annex I - To be completed nationally]
Danish: [Se bilag 1 - Udfyldes nationalt]
English: Reconstitute each vial with the volume of solvent shown in the table below, using one of the compatible solvents for reconstitution.
Danish: i tabellen nedenfor, idet der anvendes en af de forligelige solvenser til rekonstituering.
English: Complicated urinary tract infections (including pyelonephritis) Complicated intra-abdominal infections
Danish: Komplicerede urinvejsinfektioner (herunder pyelonefritis)
English: Co-administration with aminoglycosides
Danish: Samtidig administration med aminoglykosider
English: if you are taking certain medicines (called anticoagulants) to avoid an excess of blood clotting (see also Using other medicines in this leaflet) or any unexpected bleeding occurs during the treatment.
Danish: hvis du tager visse andre lægemidler (kaldet antikoagulantia), som hindre (se også Brug af indtræffer under behandlingen.
English: SPECIAL STORAGE CONDITIONS Unopened vials: Do not store above 25°C.
Danish: sted under kontrollerede og valide 6.4 Særlige opbevaringsforhold Uåbnede hætteglas: Må ikke opbevares ved temperaturer over 25 °
English: TAZOCIN is used in adults and adolescents to treat bacterial infections, such as those affecting the lower respiratory tract (lungs), urinary tract (kidneys and bladder), abdomen, skin or blood.
Danish: TAZOCIN anvendes hos voksne og unge til at behandle bakterieinfek lungerne, urinvejene (nyrer og blære), maven, huden eller blodet.
English: Simultaneous co-administration via Y-site in any manner other than listed above may result in inactivation of the aminoglycoside by TAZOCIN.
Danish: Simultan samtidig administration gennem Y-site på en hvilken som helst anden måde end anført ovenfor kan medføre inaktivering af aminoglykosidet forårsaget af Tazocin.
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
Danish: GENEREL KLASSIFIKATION FOR UDL Receptpligtigt lægemiddel
English: Non-species related breakpoints
Danish: Ikke-artsrelaterede grænseværdier
English: Only the concentration and diluents for amikacin and gentamicin with the dose of TAZOCIN listed in the above table have been established as compatible for co-administration via Y-site infusion.
Danish: Det er kun koncentrationen og fortyndingsmidlerne for amikacin og gentamicin sammen med dosen af TAZOCIN anført i ovenstående tabel, der er fastlagt som forligelige til samtidig administration gennem Y-siteinfusion.
English: TAZOCIN is compatible with lactated Ringer's solution and for co-administration via a Y-site.
Danish: TAZOCIN er forligeligt med en Ringer-laktat-opløsning og til samtidig indgift via e
English: The increase in half-life is two-fold and four-fold for piperacillin and tazobactam, respectively, at creatinine clearance below 20 ml/min compared to patients with normal renal function.
Danish: Eliminationshalveringstiden for både piperacillin og tazobactam øges Stigningen i halv kreatininclearance på under 20 ml/min sammenlignet med patienter med normal ny
English: Piperacillin may reduce the excretion of methotrexate; therefore, serum levels of methotrexate should be monitored in patients to avoid substance toxicity.
Danish: Piperacillin kan nedsætte udskillelsen af methotre kontrolleres hos patienterne for at undgå medicinforgiftning.
English: Peri/postnatal development was impaired (reduced pup weights, increase in stillbirths, increase in pup mortality) concurrent with maternal toxicity after intraperitoneal administration of tazobactam or the combination piperacillin / tazobactam in the rat.
Danish: Den peri/postnatale udvikling var hæmmet (reduceret fødselsvægt, øget antal dødfødsler, øget dødelighed oderdyrerne efter intraperitoneal administration af llin / tazobactam hos rotter.
English: Tazocin 4 g / 0.5 g is administered by intravenous infusion (over 30 minutes).
Danish: Tazocin 4 g/0,5 g indgives ved intravenøs infusion (over 30 minutter).
English: The following table summarises the treatment frequency and the dose per body weight for paediatric patients 2-12 years of age by indication or condition:
Danish: Infektioner Nedenstående tabel opsummerer doseringsshyppig r. kg legemsvægt for pædiatriske in n/tilstand heden og dosis p patienter i alderen 2 til 12 år efter dikation eller tilstand:
English: The protein binding of either piperacillin or tazobactam is unaffected by the presence of the other compound.
Danish: Hverken piperacillins eller tazobactams proteinbinding er påvirket ved tilstedeværelsen af det a
English: The prevalence of acquired resistance may vary geographically and with time for selected species, and local information on resistance is desirable, particularly when treating severe infections.
Danish: Prævale estemte arter, og lokal ønskelig, især ved behandling af svære infektioner.
English: Phamacokinetic / Pharmacodynamic relationship
Danish: Farmakokinetisk/farmakodynamisk forhold den væsentligste
English: Whenever Tazocin is used concurrently with another antibiotic (e.g. aminoglycosides), the substances must be administered separately.
Danish: Når TAZOCIN anvendes samtidigt med et andet antibiotikum (f.eks. aminoglykoside indgives separat.
English: The usual dose for children with low white blood cell counts is 80 mg / 10 mg / kg of body weight of piperacillin / tazobactam given every 6 hours into one of your veins (directly into the blood stream).
Danish: Den sædvanlige dosis for børn med lavt antal hvide blodlegemer er 80 mg/10 mg piperacillin / tazobactam pr. kg ver 6. time, og dosis indgives i en blodåre (direkte ind i blodbanen).
English: 6.6 Special precautions for disposal and other handling The reconstitution and dilution is to be made under aseptic conditions.
Danish: Rekonstituering og fortynding skal foregå under aseptiske forhold.
English: TAZOCIN 2 g / 0.25 g is a white to off-white powder supplied in a vial.
Danish: TAZOCIN 2 g/0,25 g er et hvidt til offwhite pulver, der leveres i et hætteglas.
English: As with other penicillins, concurrent administration of probenecid and piperacillin / tazobactam produces a longer half-life and lower renal clearance for both piperacillin and tazobactam; however, peak plasma concentrations of either substances are unaffected.
Danish: Som ved andre penicilliner bevirker sam længere halveringstid og lavere nyreclearance for såvel piperacillin som tazob plasmakoncentrationer for de to lægemidler påvirkes imidlertid ikke.
English: Gram-positive anaerobes
Danish: Gramnegative og grampositive anaerober
English: The usual dose is 4 g / 0.5 g of piperacillin / tazobactam given every 6-8 hours, which is given into one of your veins (directly into the blood stream).
Danish: Den sædvanlige dosis er 4 g/0,5 g piperacillin / tazobactam indgivet hver 6.-8. time, og blodåre (direkte ind i blodbanen).
English: The solution is to be inspected visually for particulate matter and discolouration prior to administration.
Danish: Opløsningen for synlige partikler eller misfarvning inden indgift.
English: Dextran 6% in 0.9% sodium chloride Lactated Ringers injection Hartmann's solution Ringer's acetate
Danish: Dextran 6 % i 0,9 % natriumchlorid Ringer-laktat-injektionsvæske Hartmanns opløsning
English: Pseudomonas aeruginosa Serratia species
Danish: Pseudomonas aeruginosa rter
English: The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment.
Danish: Symptomerne på pseudomembranøs colitis kan ind antibakterielle behandling.
English: For Susceptibility Testing Purposes, the Concentration of Tazobactam is Fixed at 4 mg/l
Danish: på test af følsomhed er konce ionen af tazobactam fastsat til 4 mg/l Artsrelaterede grænseværdier (S≤/R>)
English: Tazocin should not be mixed with other substances in a syringe or infusion bottle since compatibility has not been established.
Danish: es med andre stoffer i en sprøjte eller infusionsflaske, da forligeligheden ikke er
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt frekvensgruppe er bivirkningerne opstillet efter, hvor alvorlige de er. orligste b virkninger er st.
English: Piperacillin / tazobactam should only be used during pregnancy if clearly indicated, i.e. only if the expected benefit outweighs the possible risks to the pregnant woman and foetus.
Danish: på tvingende indikation, dvs. kun hvis den forventede fordel for den gravide kvind risici for fostret.
English: The reconstituted solutions should be withdrawn from the vial by syringe.
Danish: Den rekonstituerede opløsning bør udtrækkes af hætteglasset med en sprøjte.
English: Aminoglycoside concentration range* (mg/ml)
Danish: Amin d Taz sis forty volumen interval* (mg/ml)
English: The intravenous dose should be adjusted to the degree of actual renal impairment as follows (each patient must be monitored closely for signs of substance toxicity; medicinal product dose and interval should be adjusted accordingly):
Danish: Den intravenøse dosis bør justeres i forhold til graden af aktuel nedsat nyrefun (patienterne skal overvåges nøje for tegn på toksicitet over for st
English: beta-lactamase inhibitors; ATC code: J01C R05
Danish: Der findes ingen d patientens kliniske eller tazobactam kan reduceres ved hjælp af odynamiske egenskaber ationer med ctamase-inhibitorer; ATC-kode: J01C R05
English: Tazocin
Danish: TAZO
English: Possible side effects are listed according to the following categories: - common: affects 1 to 10 users in 100 - uncommon: affects 1 to 10 users in 1,000 - rare: affects 1 to 10 users in 10,000 - very rare: affects less than 1 user in 10,000
Danish: Se oplysningerne følgende kategorier: r hos mellem 1 og 10 ud af 100 brugere mellem 1 og 10 ud af 1.000 brugere - Sjælden: forekommer hos mellem 1 og 10 ud af 10.000 brugere mmer hos færre end 1 ud af 10.000 brugere stning, kvalme fald i antallet af hvide blodlegemer (leukopeni, neutropeni) og blodplader yk, betændelse i blodårerne (føles som ømhed eller rødme i det berørte område) ændelse i munden,
English: HOW TO USE TAZOCIN
Danish: SÅDAN SKAL DU BRUGE TAZOCIN
English: Important information about some of the ingredients of TAZOCIN TAZOCIN 2 g / 0.25 g contains 5.58 mmol (128 mg) of sodium.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i TAZOCIN TAZOCIN 2 g/0,25 g indeholder 5,58 mmol (128 m g) natrium.
English: Oral anticoagulants
Danish: Perorale antikoagulantia
English: If you miss a dose of TAZOCIN
Danish: Hvis du får for meget TAZOCIN
English: TAZOCIN 4 g / 0.5 g is a white to off-white powder supplied in a vial.
Danish: TAZOCIN 4 g/0,5 g er et hvidt til offwhite pulver, der fås i et hætteglas.
English: * Not to exceed the maximum 4 g / 0.5 g per dose over 30 minutes.
Danish: Komplicerede intraabdominale infektioner* * Må ikke overstige maksimummet på 4 g/0,5 g pr. dosis i løbet af 30 minutter.
English: Piperacillin, a broad-spectrum, semisynthetic penicillin exerts bactericidal activity by inhibition of both septum and cell-wall synthesis.
Danish: Piperacillin, der er en bredspektret, semisyntetisk penicillin, virker bakteriedræbende septum- og ce
English: Hypersensitivity to the active substances, any other penicillin-antibacterial agent or to any of the excipients.
Danish: 4.3 Kontraindikationer Overfølsomhed over for de aktive stoffer, ethvert andet penicillin-baseret antibakterielt middel eller et ert andet betalaktam-antibiotikum (f.eks.
English: Hypokalaemia may occur in patients with low potassium reserves or those receiving concomitant medicinal products that may lower potassium levels; periodic electrolyte determinations may be advisable in such patients.
Danish: Der kan forekomme hypokaliæmi hos patienter med lavt kaliumniveau eller hos patienter, der samtidigt behandles med lægemidler, der kan sænke deres kaliumniveau.
English: The inactivation of tobramycin and gentamicin by piperacillin has been demonstrated in patients with severe renal impairment.
Danish: Piperacillins inaktivering af tobramycin og gentamicin er blevet påvist hos pat nyrefunk
English: Acceptable diluents
Danish: Acceptable fortyndingsmidler
English: MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
Danish: MARKE DSFØRINGSTILLADELSESNUMMER (NUMRE) [Udfyldes nationalt]
English: No dose adjustment is required for the elderly with normal renal function or creatinine clearance values above 40 ml/min.
Danish: ldre patienter Dosisjustering er ikke nødvendig hos ældre med normal nyrefunktion eller kreatininclearance-værdier
English: Serious hypersensitivity reactions require the discontinuation of the antibiotic, and may require administration of epinephrine and other emergency measures.
Danish: , at disse reaktioner overfølsomhedsreaktioner kræver seponering af antibiotikummet og kan kræve indgivelse af epinefrin og lig vedvarende diarré, træde under eller efter den abe superinfektioner.
English: The usual dose is 4 g piperacillin / 0.5 g tazobactam given every 8 hours.
Danish: Infektioner Den sædvanlige dosis er 4 g piperacillin / 0,5 g tazobactam hver 8. time.
English: Neutropenic adults with fever suspected to be due to a bacterial infection.
Danish: Neutropeniske voksne med feber, der m istænkes at være forårsaget af en bakterieinfektion
English: 70 mg piperacillin / 8.75 mg tazobactam / kg every 8 hours.
Danish: Dosisjustering er ikke nødvendig 70 mg piperacillin / 8,75 mg tazobactam/kg hver 8. time
English: TAZOCIN Diluent volume (ml)
Danish: Tazocin ndings (ml)
English: Blood and lymphatic system disorders leukopenia, neutropenia, thrombocytopenia anaemia, haemolytic anaemia, purpura, epistaxis, bleeding time prolonged, eosinophilia agranulocytosis, pancytopenia, activated partial thromboplastin time prolonged, prothrombin time prolonged, Coombs direct test positive, thrombocythaemia
Danish: forlænget blødningstid, eosinofili agranulocytose, pancytopeni, forlænget aktiveret partiel tromboplastintid, forlænget protrombintid, positiv direkte Coombs-test, trombocytæmi eni, cytopeni an purpura, epist
English: Tazocin is indicated for the treatment of the following infections in adults and children over 2 years of age (see sections 4.2 and 5.1):
Danish: Tazocin er indiceret til behandling af følgende infektioner hos voksne og børn ov
English: Tazocin and associated names (see Annex I) 2 g / 0.25 g powder for solution for infusion Tazocin and associated names (see Annex I) 4 g / 0.5 g powder for solution for infusion Piperacillin / tazobactam
Danish: Tazocin og tilhørende navne (se bilag I) 2 g/ 0,25 g pulver til infusionsvæske, opløsning Tazocin og tilhørende navne (se bilag I) 4 g/0,5 g pulver til infusionsvæske, opløsning Piperacillin / tazobactam
English: Tazobactam, a beta-lactam structurally related to penicillins, is an inhibitor of many beta-lactamases, which commonly cause resistance to penicillins and cephalosporinsbut it does not inhibit AmpC enzymes or metallo beta-lactamases.
Danish: Tazobactam, der er et betalaktam strukturelt re betalaktamaser, der almindeligvis forårsager resistens over for penicilliner og c hæmmer ikke AmpC-enzymer eller metallobet spektrum til ogs piperacillin alen
English: Excessive serum concentrations of either piperacillin or tazobactam may be reduced by haemodialysis (see section 4.4).
Danish: For høje serumkoncentrationer af enten piperacillin hæmodialyse (se pkt.
English: Before initiating therapy with Tazocin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, other beta-lactam agents (e.g. cephalosporin, monobactam or carbapenem) and other allergens.
Danish: Før påbegyndelse af behandling med Tazocin bør det undersøges nøje, om der tidlig overfølsomhedsreaktioner over for penicilliner, andre betalaktamstoffer (f.eks. cefalo eller carbapenem) og (anafylaktiske/anafylaktoide reaktioner, herunder shock) er rapporteret hos patienter, der fik penicillinbehandling, herunder med piperacillin / tazobactam.
English: Marketing Authorisation Holder: [See Annex I - To be completed nationally]
Danish: OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN [Se bilag 1 - Udfyldes nationalt]
English: Instructions for use TAZOCIN will be given by intravenous infusion (a drip for 30 minutes).
Danish: jemmeside ng TAZOCIN indgives som intravenøs infusion (drop over 30 minutter).
English: Teratogenicity studies using intravenous administration of tazobactam or the combination piperacillin / tazobactam in mice and rats resulted in slight reductions in rat fetal weights at maternally toxic doses but did not show teratogenic effects.
Danish: Teratogenicitetsstudier, hvor der blev anvendt intravenøs administrat kombinationen piperacillin / tazobactam hos mus og rotter, medførte let nedsat fødsel doser, der var toksiske hos moderdyrene, men viste ikke nogen teratogene virkninger blandt afkommet) sideløbende med toksicitet hos m tazobactam eller kombinationen piperaci
English: Tazocin 2 g / 0.25 g powder for solution for infusion Tazocin 4 g / 0.5 g powder for solution for infusion piperacillin / tazobactam
Danish: 2 g/0,25 g pulver til infusionsvæ Tazocin 4 g/0,5 g pulver til infusionsvæske, opløsning.
English: The dose and frequency of Tazocin depends on the severity and localisation of the infection and expected pathogens.
Danish: Dosering g doseringshyppighed af Tazocin afhænger af sværhedsgraden og lokalisationen af infektionen år - Komplicerede intraabdominale infektioner en bakterieinfektion.
English: In this leaflet:
Danish: slande under følgende navne:
English: Content of vial
Danish: Indhold af hætteglas
English: These reactions sometimes have been associated with abnormalities of coagulation tests, such as clotting time, platelet aggregation and prothrombin time, and are more likely to occur in patients with renal failure.
Danish: Blødningsmanifestationer er set hos patienter, der blev behandlet med betalaktam reaktioner er ind imellem blevet forbundet med anomale koagu trombocytaggregation og protrombintid og opstår oftere hos patienter med nyresvigt.
English: Skin and subcutaneous tissue disorders rash, including maculopapular rash urticaria, pruritus erythema multiforme, dermatitis bullous, exanthema toxic epidermal necrolysis, Stevens-Johnson syndrome
Danish: Hud o subku g tane væv udslæt, herunde makulo løst uds urticari uritus ultiforme, bulløs dermatitis, exanthema toksisk epidermisk nekrolyse, Stevens-Johnsons syndrom r pr papulæt a,
English: For nosocomial pneumonia and bacterial infections in neutropenic patients, the recommended dose is 4 g piperacillin / 0.5 g tazobactam administered every 6 hours.
Danish: Ved nosokomiel lungebetændelse og bakterieinfektioner hos neutropeniske patienter er den anbefalede llin / 0,5
English: Creatinine clearance (ml/min)
Danish: interval* (mg/ml)
English: A fertility and general reproduction study in rats using intraperitoneal administration of tazobactam or the combination piperacillin / tazobactam reported a decrease in litter size and an increase in fetuses with ossification delays and variations of ribs, concurrent with maternal toxicity.
Danish: I et fertilitets- og generelt reproduktionsstudie hos rotter, hvor der blev anvendt intraperitoneal administration af tazobactam eller kombinationen piperacillin / tazobactam, blev der rapporteret et fald i dosis genfindes i uforandret form og resten som metabolit.
English: Diluted infusion solution
Danish: Fortyndet opløsning til infusionsvæske
English: There are no significant changes in piperacillin pharmacokinetics due to tazobactam.
Danish: Der er ingen signifikant ændring i piperacillins farmakokinetik på grund af tazobac at reducere clearance af tazobactam en smule.
English: Chemical and physical in-use stability has been demonstrated for up to 24 hours at 25°C and for 48 hours when stored in a refrigerator at 2-8°C, when reconstituted with one of the compatible solvents for reconstitution (see section 6.6).
Danish: Kemisk og fysisk brugsstabilitet er påvist i op til 24 timer ved 25 °C og i op til 48 ti et køleskab ved 2-8 °C efter rekonstituering med en af de forligelige solvenser til re bør sædvanligvis ikke overstige 12 timer ved 2-8 °C, medmindre rekonstituering og fortynding har fundet rede aseptiske forhold.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [To be completed nationally]
Danish: OR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Adults and adolescents - Severe pneumonia including hospital-acquired and ventilator-associated pneumonia - Complicated urinary tract infections (including pyelonephritis) - Complicated intra-abdominal infections - Complicated skin and soft tissue infections (including diabetic foot infections) Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.
Danish: - Svær lungebetændelse, herunder hospitalserhvervet og ventilatorassocieret lungebetændelse - Komplicerede urinvejsinfektioner (herunder pyelonefritis) - Komplicerede intraabdominale infektioner - Komplicerede hud-/bløddelsinfektioner (herunder diabetiske fodinfektioner)
English: The mean half-life for piperacillin and tazobactam were 32% and 55% longer, respectively, in the elderly compared with younger subjects.
Danish: Den gennemsnitlige halveringstid for piperacillin og tazobactam var hos ældre henho % længere end hos yngre forsøgspersoner.
English: TAZOCIN 4 g / 0.5 g contains 11.16 mmol (256 mg) of sodium.
Danish: TAZOCIN 4 g/0,5 g indeholder 11,16 mmol (256 mg) natrium.
English: BEFORE YOU USE TAZOCIN
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT BRUGE TAZOCIN
English: NAME OF THE MEDICINAL PRODUCT Tazocin and associated names (see Annex I) 2 g / 0.25 g powder for solution for infusion Tazocin and associated names (see Annex I) 4 g / 0.5 g powder for solution for infusion [See Annex I - To be completed nationally]
Danish: Tazocin og tilhørende navne (se bilag I) 2 g/0,25 g pulver til infusions Tazocin og tilhørende navne (se bilag I) 4 g/0,5 g pulver til infusionsvæske, opløsning [S
English: The mixing of beta-lactam antibiotics with aminoglycosides, in vitro, can result in substantial inactivation of the aminoglycoside.
Danish: 6.6. lykosider), skal stofferne in vitro kan medføre væsentlig inaktivering af aminoglykosidet.