natgillin/translations-raw huggingface dataset:
• 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.
• 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.
Uåbnede hætteglas: Må ikke opbevares ved temperaturer over 25 °C.
Unopened vials: Do not store above 25°C.
Farmakokinetikken for piperacillin, tazobactam og M1-metabolitten blev heller ikke ndret ved administration af tobramycin.
The pharmacokinetics of piperacillin, tazobactam, and the M1 metabolite were also not significantly altered by tobramycin administration.
rende midler og andre stoffer, der kan have ing på blodets koagulationssystem, herunder trombocytfunktion, skal de relevante koagulationstest foretages hyppigere og kontrolleres regelmæssigt.
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.
Brug ikke TAZOCIN efter den udløbsdato, der står på pakningen.
Do not use TAZOCIN after the expiry date which is stated on the carton and vial after “EXP”.
TAZOCIN bør ikke tilsættes til blodprodukter eller albumin-hydrolysater.
Tazocin should not be added to blood products or albumin hydrolysates.
Bestemmelse af protein med dipstick er ikke berørt.
Protein measurement with dip sticks is not affected.
Aerobe gramnegative mikroorganismer Citrobacter koseri
Aerobic Gram-negative micro-organisms Citrobacter koseri
der til bestemmelse af urinprotein kan give falsk-positive resultater.
A number of chemical urine protein measurement methods may lead to false-positive results.
TAZOCIN indeholder:
What TAZOCIN contains
Grænseværdier STs kliniske llin / tazobactam (2009-12-02,
EUCAST Clinical MIC Breakpoints for Piperacillin / Tazobactam (2009-12-02, v 1).
Det er antibiotika, der kan slå mange forskellige bakterier ihjel.
It can kill many kinds of bacteria.
lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinjer.
Any unused product or waste material should be disposed of in accordance with local requirements.
specifik antidot.
No specific antidote is known.
Metabolisme og ernæring hypokaliæmi, sænket blodglucose, sænket blodalbumin, sænket totalprotein i blodet
Metabolism and nutrition disorders hypokalaemia, blood glucose decreased, blood albumin decreased, blood protein total decreased
hvis du er overfølsom (allergisk) over for antibiotika kendt som penicilliner, cefalosporiner eller andre betalaktamase-hæmmere, da du kan være overfølsom over for TAZOCIN.
if you are allergic (hypersensitive) to antibiotics known as penicillins, cephalosporins or other beta-lactamase inhibitors, as you may be allergic to TAZOCIN.
Ikke-enzymatiske metoder til måling af glucose i urinen kan medføre falsk-positive r andre penicilliner.
Non-enzymatic methods of measuring urinary glucose may lead to false-positive results, as with other penicillins.
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.
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.
Råd fra eksperter år den lokale prævalens af resistens er af en sådan karakter, at nytten af ektionstyperne er tvivlsom.
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.
Der er ikke udført undersøgelser af karcinogeniciteten for piperacillin / tazobactam.
Carcinogenicity studies have not been conducted with piperacillin / tazobactam.
Streptococcus pneumonia Streptococcus viridans-gruppen Aerobe gramnegative mikroorganismer Acinetobacter baumannii$
Streptococcus pneumonia Streptococcus viridans group Aerobic Gram-negative micro-organisms Acinetobacter baumannii$
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
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.
Farmakoterapeutisk klassifikation: Antibakterielle midler til systemisk brug, Kombin penicilliner, inkl.
Pharmacotherapeutic group: Antibacterials for systemic use, Combinations of penicillins incl.
Øvrige indholdsstoffer: citronsyremonohydrat og dinatriumedetat (EDTA).
The other ingredients are citric acid monohydrate and edetate disodium (EDTA).
Piperacill Læs denne indlægsseddel grundigt, inden du begynder at bruge medicinen.
Read all of this leaflet carefully before you start using this medicine.
Behandling med Tazocin kan medføre fremkomst af resistente organismer, der kan sk
Therapy with Tazocin may result in the emergence of resistant organisms, which might cause superinfections.
Andre mikroorganismer Chlamydophilia pneumonia Mycoplasma pneumonia $ Arter, der fremviser naturlig intermediær følsomhed.
Mycoplasma pneumonia $ Species showing natural intermediate susceptibility.
VIRKNING OG ANVENDELSE Piperacillin hører til en gruppe lægemidler, der kaldes ”bredspektrede penicilliner”.
Piperacillin belongs to the group of medicines known as “broad-spectrum penicillin antibiotics”.
Almin ≥ 1/100 til e a
Common ≥ 1/100 to
Følsomheden for staphylococci udledes ud fra oxacillinfølsomheden.
The susceptibility of staphylococci is inferred from the oxacillin susceptibility.
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.
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.
På grund af kemisk ustabilitet bør Tazocin ikke anvendes i opløsninger, der kun indeholder
Due to chemical instability, Tazocin should not be used in solutions containing only sodium bicarbonate.
Behandling I tilfælde af en overdosis bør behandling med piperacillin / tazobactam seponeres.
In the event of an overdose, piperacillin / tazobactam treatment should be discontinued.
Pseudomembranøs colitis fremkaldt af antibiotika kan manifestere sig som alvor som kan være livstruende.
Antibiotic-induced pseudomembranous colitis may be manifested by severe, persistent diarrhoea which may be life-threatening.
Nogle læ interagere med piperacillin og tazobactam.
Some medicines may interact with piperacillin and tazobactam.
Tazocin 4 g/0,5 g Svær lungebetændelse
Tazocin 4 g / 0.5 g Severe pneumonia
Kun til engangsbr
For single use only.
Produktresumé, mærkning og indlægsseddel
Summary of product characteristics, labelling and package leaflet
Anaerobe gramnegative mikroorganismer Bacteroides fragilis-gruppen
Anaerobic Gram-negative micro-organisms Bacteroides fragilis group
Hvis blødningsmanifestationer opstår, bør antibiotikummet seponeres og passende behan funktion vurderes regelmæssigt.
If bleeding manifestations occur, the antibiotic should be discontinued and appropriate therapy instituted.
Hvis du har flere allergier, skal du huske at sige det til l sundhedsfaglig person, inden du får dette lægemiddel.
If you have several allergies, make sure you tell your doctor or other healthcare professional before receiving this product.
Børn i hæmodialyse bør få én yderligere dosis på 40 mg piperacillin / 5 mg tazobactam/kg efter hver dialyseperiode.
For children on haemodialysis, one additional dose of 40 mg piperacillin / 5 mg tazobactam / kg should be administered following each dialysis period.
Den rekonstituerede opløsning kan yderligere fortyndes til den ønskede mængde (f.eks. 50 ml til 150 ml)
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:
Dyreforsøg har påvist udviklingstoksicitet, men ingen tegn på teratogenicitet ved dos moderdyrene (se pkt.
Studies in animals have shown developmental toxicity, but no evidence of teratogenicity, at doses that are maternally toxic (see section 5.3).
F1-generationens fertilitet og F2-generationens embryonale udvikling var ikke ion af tazobactam eller svægt hos rotter ved
Fertility of the F1 generation and embryonic development of F2 generation were not impaired.
Halveringstiden for piperacillin og tazobactam stiger med henholdsvis ca. 25 % og 18 % hos med levercirrose sammenlignet med raske forsøgspersoner.
The half-life of piperacillin and of tazobactam increases by approximately 25% and 18%, respectively, in patients with hepatic cirrhosis compared to healthy subjects.
Staphylococcus-arter, koagulasenegativ, methicillinfølsom Streptococcus pyogenes
Staphylococcus species, coagulase negative, methicillin-susceptible Streptococcus pyogenes
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.
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).
cillin udskilles i lav koncentration i human mælk; tazobactam-koncentrationer i human mælk er fordel for kvinden
Piperacillin is excreted in low concentrations in human milk; tazobactam concentrations in human milk have not been studied.
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
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).
Følgende oplysninger er tiltænkt læger og sundhedspersonale: Brugervejledni
The following information is intended for medical or healthcare professionals only:
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.
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.
Din læge vil måske tjekke din nyrefunktion, inden du tager dette lægemiddel, og kan tage regelmæssige blod behandlingen.
Your doctor may want to check your kidneys before you take this medicine and may perform regular blood tests during treatment.
LISTE OVER HJÆLPESTOFFER Dinatriumedetat (EDTA) og citronsyremonohydrat.
LIST OF EXCIPIENTS Edetate disodium (EDTA) and citric acid monohydrate.
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.
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.
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).
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).
Tazobactam-metabolittens proteinbinding er ubetydelig.
Protein binding of the tazobactam metabolite is negligible.
Forligeligheden af Tazocin med andre aminoglykosider er ikke blevet fastlagt.
Compatibility of TAZOCIN with other aminoglycosides has not been established.
Hæmodialyse fjerner 30-50 % af piperacillin / tazobactam, og yderligere 5 % af tazo som tazobactam-metabolit.
Haemodialysis removes 30% to 50% of piperacillin / tazobactam, with an additional 5% of the tazobactam dose removed as the tazobactam metabolite.
100 mg piperacillin / 12,5 mg tazobactam pr. kg legemsvægt/hver 8. time
100 mg Piperacillin / 12.5 mg Tazobactam per kg body weight / every 8 hours
TAZOCIN kan anvendes til enter med lav Ved visse alvorlige infektioner kan lægen overveje at bruge TAZOCIN sammen med andre antibiotika.
In certain serious infections, your doctor may consider using TAZOCIN in combination with other antibiotics.
I så tilfælde bør du sige det til lægen eller en anden sundhedsfaglig person.
In this case, you should inform your doctor or other healthcare professional.
Nedsat leverfunktion Dosisjustering er ikke nødvendig (se pkt.
No dose adjustment is necessary (see section 5.2).
Fortæl det til lægen, hvis du skal iddel, der bruges til at behandle kræft, artritis eller psoriasis).
methotrexate (medicine used to treat cancer, arthritis or psoriasis).
methotrexat (et lægem tazobacta lægemidler, der reducerer kaliumniveauet i blodet (f.eks. tabletter, der øger vand visse lægemidler mod kræft).
medicines that reduce the level of potassium in your blood (e.g. tablets enhancing urination or some medicines for cancer).
Eliminationshalveringstiden for både piperacillin og tazobactam øges ved nedsat renal clearance.
The elimination half-lives of both piperacillin and tazobactam are increased with decreasing renal clearance.
Anaerobe grampositive mikroorganismer Clostridium-arter
Anaerobic Gram-positive micro-organisms Clostridium species
Dette bør tages med i overvejelserne h kontrolleret natriumdiæt.
This should be taken into consideration if you are on a controlled-sodium diet.
Tazocin 2 g/0,25 g indgives ved intravenøs infusion (over 30 minutter).
Tazocin 2 g / 0.25 g is administered by intravenous infusion (over 30 minutes).
Der er ikke observeret nogen farmakokinetiske interaktioner mellem piperacil vancomycin.
No pharmacokinetic interactions have been noted between piperacillin / tazobactam and vancomycin.
Ligesom ved behandling med andre penicilliner kramper, når høje doser indgives, især hos patienter med nedsat
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.
Tazocin kan anvendes til behandling af neutropeniske patienter med feber, der mistænkes at være forårsaget af en bakterieinfektion.
Tazocin may be used in the management of neutropenic patients with fever suspected to be due to a bacterial infection.
Almindelige bivirkninger: diarré, opka hududslæt
Common side effects: diarrhoea, vomiting, nausea skin rashes
Ved ngen typisk inden for 5-10 minutter (oplysninger vedrørende håndtering
When swirled constantly, reconstitution generally occurs within 5 to 10 minutes (for details on handling, please see below).
Prevotella-arter
Prevotella species
Tazobactam udvider piperacillins antibiotiske å at omfatte mange betalaktamaseproducerende bakterier, der er blevet resistente over for e.
Tazobactum extends the antibiotic spectrum of piperacillin to include many beta-lactamase-producing bacteria that have acquired resistance to piperacillin alone.
Ringer-acetat Ringer-acetat/malat
Ringer's acetate/malate
Komplicerede intraabdominale infektioner Hud/bløddelsinfektioner (herunder diabetiske fodinfektioner)
Skin and soft tissue infections (including diabetic foot infections)
Nervesystemet hovedpine, insom i n
Nervous system disorders headache, insomnia
Piperacillin / tazobactam fordeles i stor udstrækning i væv og kropsvæsker, herunder tarmslimhinder, galdeblære, lunger, galde og knogler.
Piperacillin / tazobactam is widely distributed in tissues and body fluids including intestinal mucosa, gallbladder, lung, bile, and bone.
hvis du sundhedsfagli hvis du tror, at du har fået en ny infektion, eller en eksisterende infektion er bl
if you think you developed a new or worsening infection.
0,9 % (9 mg/ml) natriumchlorid-injektionsvæske, opløsning Sterilt vand til injektionsv (1)
0.9% (9 mg/ml) sodium chloride solution for injection Sterile water for injections(1)
Leukopeni og neutropeni kan forekomme, især ved langvarig behandling; derfor bør den hæmatopoietiske kan der opstå neurologiske komplikationer i form af nyrefunktion.
Leukopenia and neutropenia may occur, especially during prolonged therapy; therefore, periodic assessment of haematopoietic function should be performed.
neuromuskulære blokade, der forårsages af de ikke-depolariserende muskelrelaksantia, vil kunne blive deværelsen af piperacillin.
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.
Din læge kan også teste dit blod for at sikre, at du bliver behandlet med den rette d taget lægemidlet
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.
[Se bilag 1 - Udfyldes nationalt]
[See Annex I - To be completed nationally]
i tabellen nedenfor, idet der anvendes en af de forligelige solvenser til rekonstituering.
Reconstitute each vial with the volume of solvent shown in the table below, using one of the compatible solvents for reconstitution.
Komplicerede urinvejsinfektioner (herunder pyelonefritis)
Complicated urinary tract infections (including pyelonephritis) Complicated intra-abdominal infections
Samtidig administration med aminoglykosider
Co-administration with aminoglycosides
hvis du tager visse andre lægemidler (kaldet antikoagulantia), som hindre (se også Brug af indtræffer under behandlingen.
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.
sted under kontrollerede og valide 6.4 Særlige opbevaringsforhold Uåbnede hætteglas: Må ikke opbevares ved temperaturer over 25 °
SPECIAL STORAGE CONDITIONS Unopened vials: Do not store above 25°C.
TAZOCIN anvendes hos voksne og unge til at behandle bakterieinfek lungerne, urinvejene (nyrer og blære), maven, huden eller blodet.
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.
Simultan samtidig administration gennem Y-site på en hvilken som helst anden måde end anført ovenfor kan medføre inaktivering af aminoglykosidet forårsaget af Tazocin.
Simultaneous co-administration via Y-site in any manner other than listed above may result in inactivation of the aminoglycoside by TAZOCIN.
GENEREL KLASSIFIKATION FOR UDL Receptpligtigt lægemiddel
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
Ikke-artsrelaterede grænseværdier
Non-species related breakpoints
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.
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.
TAZOCIN er forligeligt med en Ringer-laktat-opløsning og til samtidig indgift via e
TAZOCIN is compatible with lactated Ringer's solution and for co-administration via a Y-site.
Eliminationshalveringstiden for både piperacillin og tazobactam øges Stigningen i halv kreatininclearance på under 20 ml/min sammenlignet med patienter med normal ny
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.
Piperacillin kan nedsætte udskillelsen af methotre kontrolleres hos patienterne for at undgå medicinforgiftning.
Piperacillin may reduce the excretion of methotrexate; therefore, serum levels of methotrexate should be monitored in patients to avoid substance toxicity.
Den peri/postnatale udvikling var hæmmet (reduceret fødselsvægt, øget antal dødfødsler, øget dødelighed oderdyrerne efter intraperitoneal administration af llin / tazobactam hos rotter.
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.
Tazocin 4 g/0,5 g indgives ved intravenøs infusion (over 30 minutter).
Tazocin 4 g / 0.5 g is administered by intravenous infusion (over 30 minutes).
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:
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:
Hverken piperacillins eller tazobactams proteinbinding er påvirket ved tilstedeværelsen af det a
The protein binding of either piperacillin or tazobactam is unaffected by the presence of the other compound.
Prævale estemte arter, og lokal ønskelig, især ved behandling af svære infektioner.
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.
Farmakokinetisk/farmakodynamisk forhold den væsentligste
Phamacokinetic / Pharmacodynamic relationship
Når TAZOCIN anvendes samtidigt med et andet antibiotikum (f.eks. aminoglykoside indgives separat.
Whenever Tazocin is used concurrently with another antibiotic (e.g. aminoglycosides), the substances must be administered separately.
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).
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).
Rekonstituering og fortynding skal foregå under aseptiske forhold.
6.6 Special precautions for disposal and other handling The reconstitution and dilution is to be made under aseptic conditions.
TAZOCIN 2 g/0,25 g er et hvidt til offwhite pulver, der leveres i et hætteglas.
TAZOCIN 2 g / 0.25 g is a white to off-white powder supplied in a vial.
Som ved andre penicilliner bevirker sam længere halveringstid og lavere nyreclearance for såvel piperacillin som tazob plasmakoncentrationer for de to lægemidler påvirkes imidlertid ikke.
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.
Gramnegative og grampositive anaerober
Gram-positive anaerobes
Den sædvanlige dosis er 4 g/0,5 g piperacillin / tazobactam indgivet hver 6.-8. time, og blodåre (direkte ind i blodbanen).
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).