natgillin/translations-raw huggingface dataset:
Dog har præmixopløsningen vist fysisk og kemisk stabilitet i en periode på 8 timer, både når den blev opbevaret mellem +2°C og +8°C, og når den blev opbevaret ved stuetemperatur (under 25ºC).
However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between + 2 °C and + 8 °C or at room temperature (below 25 °C).
4. 2. 2 Injicer derefter den beregnede mængde Docetaxel Winthrop - præmix i en 250 ml infusionspose med enten 5% glucose eller 0, 9% NaCl.
4.2.2 Inject the required premix volume into a 250 ml infusion bag or bottle containing either 5% glucose solution or 0.9% sodium chloride solution.
4. 2. 4 Docetaxel Winthrop infusionsopløsning skal bruges inden for 4 timer og anvendes under aseptiske forhold som en 1- times infusion ved stuetemperatur (under 25ºC) og under normale lysforhold.
4.2.4 The Docetaxel Winthrop infusion solution should be used within 4 hours and should be aseptically administered as a 1-hour infusion under room temperature (below 25 °C) and normal lighting conditions.
4. 2. 5 Som alle andre parenterale praeparater bør Docetaxel Winthrop præmix- opløsning og infusionsvæske inspiceres visuelt inden brug, og opløsninger med udfældning skal kasseres.
4.2.5 As with all parenteral products, Docetaxel Winthrop premix solution and infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
107 5.
107 5.
Doribax er et lægemiddel, der indeholder det aktive stof doripenem.
Doribax is a medicine containing the active substance doripenem.
Det fås som et pulver til fremstilling af en infusionsopløsning (intravenøst drop).
It is available as a powder to be made up into a solution for infusion (drip into a vein).
"Kompliceret" betyder, at infektionen er vanskelig at behandle. • Komplicerede infektioner i urinvejene (de strukturer, som leder urinen).
It is used to treat the following infections in adults: • nosocomial pneumonia (an infection of the lungs). ‘ Nosocomial ’ means that the infection was caught in hospital, including pneumonia caused by the use of a ventilator (a machine that helps a patient to breathe); • complicated infections in the abdomen (tummy). ‘ Complicated ’ means that the infection is difficult to treat; • complicated infections of the urinary tract (the structures that carry urine).
Før Doribax anvendes, skal lægen overveje de gældende officielle retningslinjer for brug af antibiotika.
Before using Doribax, doctors should consider official guidance on the use of antibiotics.
Standarddosis af Doribax er 500 mg hver 8. time.
The standard dose of Doribax is 500 mg every eight hours.
Hver infusion varer en time, selvom nogle patienter med lungebetændelse kan have brug for infusioner, som varer fire timer.
Each infusion lasts for one hour, although some patients with pneumonia may need infusions lasting four hours.
Behandlingen varer som regel mellem fem og 14 dage afhængig af infektionens type og sværhedsgrad, og hvordan patienten reagerer på behandlingen.
Treatment usually continues for between five and 14 days, depending on the type and severity of the infection and the patient’ s response.
Fordi medicinen udskilles fra kroppen via nyrerne, bør dosen af Doribax nedsættes hos patienter, som har moderate eller svære problemer med nyrerne.
Because the medicine is removed from the body by the kidneys, the dose of Doribax should be reduced in patients who have moderate or severe problems with their kidneys.
Doribax anbefales ikke til børn under 18 år, da der ikke foreligger oplysninger om dets sikkerhed og virkning i denne aldersgruppe.
Doribax is not recommended for use in children under 18 years of age because of a lack of information on safety and effectiveness in this age group.
Det aktive stof i Doribax, doripenem, er et antibiotikum, som tilhører gruppen "carbapenemer".
The active substance in Doribax, doripenem, is an antibiotic that belongs to the group ‘ carbapenems’.
Listen over bakterier, som Doribax er aktiv over for, fremgår af produktresuméet, der ligeledes er en del af denne EPAR.
The list of bacteria against which Doribax is active can be found in the Summary of Product Characteristics (also part of the EPAR).
Virkningerne af Doribax blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of Doribax were first tested in experimental models before being studied in humans.
Doribax blev undersøgt i fem hovedundersøgelser, som sammenlignede Doribax med andre antibiotika. • To undersøgelser sammenlignede Doribax med piperacillin/ tazobactam eller imipenem hos i alt 979 patienter med nosokomiel pneumoni. • To undersøgelser sammenlignede Doribax med meropenem hos i alt 962 patienter med komplicerede infektioner i maven. • En undersøgelse sammenlignede Doribax med levofloxacin hos 753 patienter med komplicerede urinvejsinfektioner.
Doribax has been studied in five main studies that compared Doribax with other antibiotics: • two studies compared Doribax with piperacillin/ tazobactam or imipenem in a total of 979 patients with nosocomial pneumonia; • two studies compared Doribax with meropenem in a total of 962 patients with complicated infections in the abdomen; • one study compared Doribax with levofloxacin in 753 patients with complicated urinary tract infections.
I alle undersøgelserne var det primære effektmål antallet af patienter, hvis infektion blev kureret efter behandlingen.
In all of the studies, the main measure of effectiveness was the number of patients whose infection was cured after treatment.
Doribax var lige så effektivt til behandling af infektioner som de andre antibiotika: • Ifølge de samlede resultater af de to undersøgelser med nosokomiel pneumoni, blev 75% af de patienter, som fik Doribax, helbredt (195 ud af 260) sammenlignet med 72% af de patienter, som tog piperacillin/ tazobactam eller imipenem (174 ud af 241). • Ifølge de samlede resultater af de to undersøgelser med komplicerede maveinfektioner, blev 85% af de patienter, som fik Doribax, helbredt (275 ud af 325) sammenlignet med 84% af de patienter, som fik meropenem (260 ud af 309). • Ved komplicerede urinvejsinfektioner blev 82% af de patienter, som fik Doribax, helbredt (230 ud af 280) sammenlignet med 83% af de patienter, som fik levofloxacin (221 ud af 265).
Doribax was as effective as the other antibiotics in treating the infections: • looking at the results of the two studies in nosocomial pneumonia taken together, 75% of the patients receiving Doribax were cured (195 out of 260), compared with 72% of the patients taking piperacillin/ tazobactam or imipenem (174 out of 241); • looking at the results of the two studies of complicated abdominal infections taken together, 85% of the patients receiving Doribax were cured (275 out of 325), compared with 84% of the patients receiving meropenem (260 out of 309); • in complicated urinary tract infections, 82% of the patients receiving Doribax were cured (230 out of 280), compared with 83% of the patients receiving levofloxacin (221 out of 265).
Den hyppigste bivirkning ved Doribax (som optræder hos flere end 1 ud af 10 patienter) er hovedpine.
The most common side effect with Doribax (seen in more than 1 patient in 10) is headache.
Den fuldstændige liste over de indberettede bivirkninger ved Doribax fremgår af indlægssedlen.
For the full list of all side effects reported with Doribax, see the Package Leaflet.
Doribax bør ikke anvendes til personer, som kan være overfølsomme (allergiske) over for doripenem eller andre carbapenemer.
Doribax should not be used in people who may be hypersensitive (allergic) to doripenem or to other carbapenems.
Det må ikke anvendes til patienter, som har svær allergi over for andre "beta- lactam" - antibiotika som penicilliner eller cefalosporiner.
It must not be used in patients who are severely allergic to other ‘ beta-lactam’ antibiotics, such as penicillins or cephalosporins.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Doribax er større end risiciene ved behandling af nosokomiel pneumoni, komplicerede infektioner i maven og komplicerede urinvejsinfektioner hos voksne.
The Committee for Medicinal Products for Human Use (CHMP) decided that Doribax’ s benefits are greater than its risks for the treatment of nosocomial pneumonia, complicated intra-abdominal infections and complicated urinary tract infections in adults.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Doribax.
The Committee recommended that Doribax be given marketing authorisation.
Andre oplysninger om Doribax:
Other information about Doribax:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Doribax til Janssen- Cilag International NV den 25. juli 2008.
The European Commission granted a marketing authorisation valid throughout the European Union for Doribax to Janssen-Cilag International NV on 25 July 2008.
Den fuldstændige EPAR for Doribax findes her.
The full EPAR for Doribax can be found here.
EU- nummer EU/ 1/ 08/ 467/ 001
EU/ 1/ 08/ 467/ 001
Særnavn Doribax
Doribax
Lægemiddelform Pulver til infusionsvæske, opløsning
Powder for solution for infusion
Paknings- størrelse 10 hætteglas
10 vials
Doribax 500 mg pulver til infusionsvæske, opløsning
Doribax 500 mg powder for solution for infusion
Hvert hætteglas indeholder doripenemmonohydrat (svarende til 500 mg doripenem).
Each vial contains doripenem monohydrate equivalent to 500 mg doripenem.
Dette lægemiddel indeholder ingen hjælpestoffer.
The medicinal product does not contain any excipients.
Pulver til infusionsvæske, opløsning (pulver til infusion)
Powder for solution for infusion (Powder for infusion)
Et hvidt eller let gulligt offwhite krystallinsk pulver
A white to slightly yellowish off-white crystalline powder
4. 4 og 5. 1):
Doribax is indicated for the treatment of the following infections in adults (see sections 4.4 and 5.1):
• Nosokomiel pneumoni, herunder respiratorassocieret pneumoni • Komplicerede intraabdominale infektioner • Komplicerede urinvejsinfektioner
• Nosocomial pneumonia (including ventilator– associated pneumonia) • Complicated intra-abdominal infections • Complicated urinary tract infections
De officielle retningslinjer om korrekt brug af antibiotika bør følges.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Den anbefalede dosis og indgivelsesmåde ved infektion angives i følgende tabel:
The recommended dosage and administration by infection is shown in the following table:
Infektion Nosokomiel pneumoni, herunder respiratorassocieret pneumoni
Nosocomial pneumonia including ventilator– associated pneumonia
Dosis 500 mg
500 mg
Frekvens hver 8. time
every 8 hours
Infusionstid 1 eller 4 timer *
1 or 4 hours*
Kompliceret intraabdominal infektion Kompliceret urinvejsinfektion, herunder pyelonefritis
Complicated intra-abdominal infection Complicated UTI, including pyelonephritis
500 mg 500 mg
500 mg 500 mg
hver 8. time hver 8. time
every 8 hours every 8 hours
5. 1).
*Based mainly on PK/ PD considerations, a 4-hour infusion time may be more suitable for infection with less susceptible pathogens (see section 5.1).
Se pkt.
This dosing regimen should also be considered in particularly severe infections.
6. 3. for informationer om holdbarhed af infusionsopløsning.
For infusion solution shelf life see section 6.3.
Den sædvanlige behandlingsvarighed med doripenem er 5- 14 dage og bør være baseret på sværhedsgrad, infektionssted og patientens kliniske respons.
The usual treatment duration of doripenem therapy is 5-14 days and should be guided by the severity, site of the infection and the patient’ s clinical response.
Der er ikke foretaget undersøgelser af sikkerheden ved længere behandlingsvarighed.
Doripenem was given for up to 14 days in clinical studies and the safety of longer durations of therapy has not been established.
Så snart der er opnået en klinisk forbedring efter påbegyndt intravenøs behandling med doripenem, kan der skiftes til passende oral behandling for at fuldende behandlingsforløbet.
After commencing treatment with intravenous doripenem, a switch to appropriate oral therapy to complete the treatment course is possible once clinical improvement has been establised.
2 Dosering til børn Doribax anbefales ikke til børn under 18 år på grund af manglende sikkerheds - og effektdata.
Dosage in paediatric patients Doribax is not recommended for use in children below 18 years of age due to a lack of safety and efficacy data.
Dosering til patienter med nedsat nyrefunktion Til patienter med let nedsat nyrefunktion (dvs. en creatinin- clearance (CrCl) på 51- 79 ml/ min) kræves ingen dosisjustering.
2 Dosage in patients with impaired renal function In patients with mild renal impairment (i. e. creatinine clearance (CrCl) is 51-79 ml/ min), no dosage adjustment is necessary.
Til patienter med moderat nedsat nyrefunktion (CrCl 30 til < 50 ml/ min) gives 250 mg Doribax hver 8. time.
In patients with moderate renal impairment (CrCl 30 to < 50 ml/ min), the dosage of Doribax should be 250 mg every 8 hours.
Til patienter med svært nedsat nyrefunktion (CrCl < 30 ml/ min) gives 250 mg Doribax hver 12. time.
In patients with severe renal impairment (CrCl < 30 ml/ min), the dosage of Doribax should be 250 mg every 12 hours.
5. 2).
Due to limited clinical data and an expected increased exposure of doripenem and its metabolite, Doribax should be used with caution in patients with severe renal impairment (see section 5.2).
Dosering til dialysepatienter Doribax udskilles ved hæmodialyse, men der findes ikke tilstrækkelig information til at foretage anbefalinger om dosisjustering til patienter i dialyse.
Dosage in patients on dialysis Doribax is haemodialyzable; however, there is insufficient information to make dose adjustment recommendations in patients on dialysis.
5. 2).
Therefore, Doribax is not recommended for patients on any type of dialysis (see section 5.2).
5. 2).
Dosage in elderly patients (≥ 65 years of age) No dosage adjustment is necessary in elderly patients, except in cases of moderate to severe renal insufficiency (see Dosage in patients with impaired renal function above and section 5.2).
Dosering til patienter med nedsat leverfunktion Der kræves ingen dosisjustering.
Dosage in patients with impaired hepatic function No dosage adjustment is necessary.
6. 6) før indgift ved intravenøs infusion over en periode på 1 eller 4 timer.
Method for administration Doribax is to be reconstituted and then further diluted (see section 6.6) prior to administration by intravenous infusion over a period of one or four hours.
Overfølsomhed over for det aktive stof Overfølsomhed over for andre carbapenemantibiotika Svær overfølsomhed (f. eks. anafylaktisk reaktion, svær hudreaktion) over for ethvert andet betalaktamantibiotikum (f. eks. penicillin eller cefalosporin).
Hypersensitivity to the active substance Hypersensitivity to any other carbapenem antibacterial agent Severe hypersensitivity (e.g. anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (e.g. penicillins or cephalosporins).
Alvorlige og i nogle tilfælde dødelige overfølsomhedsreaktioner (anafylaksi) er set hos patienter, som har modtaget betalaktamantibiotika.
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have occurred in patients receiving beta-lactam antibiotics.
Før behandling med Doribax iværksættes, bør der udspørges grundigt til tidligere overfølsomhedsreaktioner over for andre aktive stoffer i denne klasse og over for betalaktamantibiotika.
Before therapy with Doribax is started, careful inquiry should be made concerning a previous history of hypersensitivity reactions to other active substances in this class or to beta-lactam antibiotics.
Hvis der optræder overfølsomhedsreaktioner over for Doribax, bør behandlingen straks standses og relevante forholdsregler træffes.
Should a hypersensitivity reaction to Doribax occur, it should be discontinued immediately and appropriate measures taken.
Alvorlige akutte overfølsomhedsreaktioner (anafylaksi) kræver øjeblikkelig akut behandling.
Serious acute hypersensitivity (anaphylactic) reactions require immediate emergency treatment.
Der er i sjældne tilfælde rapporteret kramper ved behandling med andre carbapenemer.
Seizures have infrequently been reported during treatment with other carbapenems.
Pseudomembranøs colitis forårsaget af Clostridium difficile er rapporteret med Doribax, som med næsten alle antibiotika og kan variere i sværhedsgrad fra let til livstruende.
Pseudomembranous colitis due to Clostridium difficile has been reported with Doribax as with nearly all anti-bacterial agents and may range in severity from mild to life-threatening.
4. 8).
Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of Doribax (see section 4.8).
Patienter bør monitoreres nøje under behandling.
Patients should be carefully monitored during therapy.
I forsøg er der ved anvendelse af Doribax via inhalation opstået pneumonitis.
When Doribax was used investigationally via inhalation, pneumonitis occurred.
Doribax bør derfor ikke indgives ad denne administrationsvej.
Therefore, Doribax should not be administered by this route.
3 Beskrivelse af patientgruppen, der er blevet behandlet i kliniske forsøg I to kliniske forsøg med patienter med nosokomiel pneumoni (N = 979) havde 60% af de klinisk evaluerbare Doribax- behandlede patienter respiratorassocieret pneumoni.
3 Description of the patient population treated in clinical studies In two clinical trials of patients with nosocomial pneumonia (N=979), 60% of the clinically-evaluable Doribax-treated patients had ventilator-associated pneumonia (VAP).
Af disse havde 50% sent opstået respiratorassocieret pneumoni (defineret som opstået efter 5 dages mekanisk ventilation), og 54% havde en APACHE (akut fysiologisk og kronisk helbredsevaluering) II- score på > 15 og 32% modtog samtidig aminoglycosider (76% i mere end 3 dage).
Of these, 50% had late-onset VAP (defined as that occurring after five days of mechanical ventilation), 54% had an APACHE (Acute Physiology And Chronic Health Evaluation) II score > 15 and 32% received concomitant aminoglycosides (76% for more than 3 days).
I to kliniske forsøg med patienter med komplicerede intraabdominale infektioner (N = 962) var appendix (62%) det mest almindelige anatomiske infektionssted hos mikrobiologisk evaluerbare Doribax- behandlede patienter.
In two clinical trials of patients with complicated intra-abdominal infections (N=962) the most common anatomical site of infection in microbiologically-evaluable Doribax-treated patients was the appendix (62%).
Af disse havde 51% generaliseret peritonitis ved baseline.
Of these, 51% had generalised peritonitis at baseline.
Andre infektionskilder omfattede colonperforation (20%), kompliceret cholecystis (5%) og infektioner andre steder (14%).
Other sources of infection included colon perforation (20%), complicated cholecystitis (5%) and infections at other sites (14%).
11% havde en APACHE II- score på > 10, 9, 5% havde postoperative infektioner, 27% havde en enkelt eller flere intraabdominale abscesser, og 4% havde samtidig bakteriæmi ved baseline.
Eleven percent had an APACHE II score of > 10, 9.5% had post-operative infections, 27% had single or multiple intra-abdominal abscesses and 4% had concurrent bacteraemia at baseline.
I to kliniske forsøg med patienter med komplicerede urinvejsinfektioner (N = 1. 179) havde 52% af de mikrobiologisk evaluerbare Doribax- behandlede patienter komplicerede nedre urinvejsinfektioner, og 48% havde pyelonefritis, 16% af disse var komplicerede.
In two clinical trials of patients with complicated urinary tract infections (N=1179), 52% of microbiologically-evaluable Doribax-treated patients had complicated lower urinary tract infections and 48% had pyelonephritis, of which 16% were complicated.
I alt havde 54% af patienterne en persisterende komplikation, 9% havde samtidig bakteriæmi, og 23% var inficeret med en levofloxacinresistent uropatogen ved baseline.
Overall, 54% of patients had a persistent complication, 9% had concurrent bacteraemia and 23% were infected with a levofloxacin resistant uropathogen at baseline.
Der er begrænset erfaringen med patienter, som er alvorligt immunkompromitteret, er i immunsuppressiv behandling og patienter med alvorlig neutropeni, idet disse patienter var ekskluderet i fase 3 forsøgene.
The experience in patients who are severely immunocompromised, receiving immunosuppressive therapy, and patients with severe neutropenia is limited since this population was excluded from phase 3 trials.
Doripenem gennemgår ringe eller ingen cytokrom P450- medieret (CYP450) metabolisme.
Doripenem undergoes little to no Cytochrome P450 (CYP450) mediated metabolism.
På baggrund af in vitro- forsøg forventes det ikke, at doripenem inhiberer eller inducerer aktiviteterne af CYP450.
Based on in vitro studies it is not expected that doripenem will inhibit or induce the activities of CYP450.
5. 2).
Therefore, no CYP450-related drug interactions are to be expected (see section 5.2).
Carbapenemantibiotika kan reducere valproatkoncentrationen i serum.
Carbapenem antibacterial agents may reduce serum valproic acid concentrations.
Valproatkoncentrationen i serum bør derfor monitoreres, hvis Doribax indgives samtidig med valproat.
Serum concentrations of valproic acid should be monitored if Doribax is administered concomitantly with valproic acid.
I et interaktionsforsøg steg den gennemsnitlige doripenem- AUC med 75% efter samtidig indgift af probenecid.
In an interaction study, the mean doripenem AUC increased by 75% following co-administration with probenecid.
Samtidig indgift af probenecid og Doribax anbefales derfor ikke.
Therefore, co-administration of probenecid with Doribax is not recommended.
Det kan ikke udelukkes, at der kan være en interaktion med andre lægemidler, der elimineres ved renal tubulær sekretion.
An interaction with other drugs eliminated by renal tubular secretion cannot be excluded.
Der forefindes begrænsede kliniske data fra gravide i behandling med doripenem.
For doripenem, limited clinical data on exposed pregnancies are available.
5. 3).
Animal studies are insufficient with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Doribax bør ikke anvendes under graviditet medmindre, der er en tvingende indikation.
Doribax should not be used during pregnancy unless clearly necessary.
Det vides ikke, om doripenem udskilles i human brystmælk.
It is unknown whether doripenem is excreted in human breast milk.
Et forsøg med rotter har vist, at doripenem og dets metabolit udskilles i mælk.
A study in rats has shown that doripenem and its metabolite are transferred to milk.
Beslutningen om, hvorvidt amning skal fortsættes/ afbrydes, eller om behandling med Doribax skal fortsættes/ afbrydes, bør foretages under hensyntagen til amningens fordel for barnet og Doribax- behandlingens fordel for kvinden.
A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Doribax should be made taking into account the benefit of breast-feeding to the child and the benefit of Doribax therapy to the woman.
Det forventes ikke på baggrund af indberettede bivirkninger, at Doribax vil påvirke evnen til at føre motorkøretøj eller betjene maskiner.
Based on reported adverse drug reactions, it is not anticipated that Doribax will affect the ability to drive and use machines.
Hos 3. 142 voksne patienter (hvoraf 1. 817 modtog Doribax), som blev evalueret for sikkerhed i kliniske fase II - og fase III- forsøg, forekom der bivirkninger hos 32% på grund af Doribax 500 mg indgivet hver 8. time.
In 3,142 adult patients (1817 of which received Doribax) evaluated for safety in phase 2 and phase 3 clinical trials, adverse reactions due to Doribax 500 mg every 8 hours occurred at rate of 32%.
Doribax blev seponeret på grund af bivirkninger hos i alt 0, 1% af patienterne.
Doribax was discontinued because of adverse drug reactions in 0.1% of patients overall.