FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with severe renal impairment (creatinine clearance below 20 ml/min) or those on renal replacement therapy, the appropriate timing and amount of subsequent doses largely depend on the modality of RRT and should be based on serum vancomycin trough levels and on residual renal function (see section 4.4).
Danish: Hos patienter med alvorlig nedsat nyrefunktion (kreatininclearance under 20 ml/min) eller patienter i nyreerstatningsbehandling afhænger timing og mængde af efterfølgende doser i høj grad af RRT's modalitet og bør baseres på dal-værdierne af vancomycin i serum og den resterende nyrefunktion (se pkt.
English: Therefore, the side effects and frequencies which are reported for vancomycin given as infusion are included.
Danish: Derfor er der medtaget oplysninger om de bivirkninger, der er indberettet for vancomycin givet som infusion, og den hyppighed, de kan forekomme med.
English: Continuous infusion: loading dose of 1000 mg/L per litter of dialysate followed by 25 mg/L (after 3-6 h of loading dose) in all exchanges.
Danish: Kontinuerlig infusion: Ladningsdosis på 1000 mg/l pr. liter dialysat efterfulgt af 25 mg/l (3-6 timer efter ladningsdosis) ved alle skift.
English: In patients on intermittent haemodialysis, vancomycin levels should be usually obtained before the start of the haemodialysis session.
Danish: Hos patienter i intermitterende hæmodialyse skal vancomycinniveauer normalt opnås inden starten af hæmodialysesessionen.
English: Ototoxicity has primarily been reported in patients given high doses, or in those on concomitant treatment with other ototoxic medicinal product like aminoglycoside, or in those who had a preexisting reduction in kidney function or hearing.
Danish: Ototoksicitet er primært blevet rapporteret hos patienter, der fik høje doser; eller ved samtidig behandling med andre ototoksiske lægemidler som aminoglykosid; eller hos patienter, der havde en eksisterende reduktion i nyrefunktion eller hørelse.
English: Drug interactions with anti-motility agents and proton pump inhibitors
Danish: Lægemiddelinteraktioner med antipropulsiva og protonpumpehæmmere
English: QUALITATIVE AND QUANTITATIVE COMPOSITION [For all vancomycin 500 mg powder for concentrate for solution for infusion, the following wording to be reflected in this section]
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING [For alle vancomycin 500 mg pulver til koncentrat til infusionsvæske, opløsning, skal følgende ordlyd afspejles i dette afsnit]
English: As vancomycin in combination with a cephalosporin may also have an antagonistic effect against some Staphylococcus epidermidis strains and in combination with rifampicin against some Staphylococcus aureus strains, preceding synergism testing is useful.
Danish: Da vancomycin i kombination med et cefalosporin også kan have en antagonistisk virkning mod nogle Staphylococcus epidermidis-stammer og, i kombination med rifampicin, mod nogle Staphylococcus aureus-stammer, er forudgående tests for synergisme nyttige.
English: Peri-operative prophylaxis of bacterial endocarditis in all age groups The recommended dose is an initial dose of 15 mg/kg prior to induction of anaesthesia.Depending on the duration of surgery, a second vancomycin dose may be required.
Danish: Peri-operativ profylakse af bakteriel endokarditis til alle aldersgrupper Den anbefalede dosis er en initialdosis på 15 mg/kg før induktion af anæstesi.
English: Vancomycin is active against gram-positive bacteria, such as staphylococci, streptococci, enterococci, pneumococci, and clostridia.
Danish: Vancomycin er aktivt mod grampositive bakterier, såsom stafylokokker, streptokokker, enterokokker, pneumokokker, og clostridier.
English: Drug interactions with anti-motility agents and proton pump inhibitors Anti-motility agents should be avoided and proton pump inhibitor use should be reconsidered.
Danish: Interaktioner med antipropulsiva og protonpumpehæmmere Antipropulsiva bør undgås, og anvendelse af protonpumpehæmmere bør tages op til fornyet overvejelse.
English: [For parenteral formulations authorised for intraperitoneal use:] - In patients receiving peritoneal dialysis, vancomycin is used in adults and children for the treatment of infections related to peritoneal dialysis.
Danish: [For parenterale formuleringer godkendt til intraperitoneal anvendelse:] - hos patienter i peritonealdialyse anvendes vancomycin til voksne og børn til behandling af infektioner relateret til peritonealdialyse.
English: [for vancomycin powder for concentrate for infusion authorised for oral use] Vancomycin can be given orally in adults and children for the treament of infection of the mucosa of the small and the large intestines with damage to the mucosae (pseudomembranous colitis), caused by the Clostridium difficile bacterium.
Danish: [For vancomycin pulver til koncentrat til infusionsvæske godkendt til oral anvendelse] Vancomycin kan gives oralt til voksne og børn til behandling af infektion i slimhinden i tynd- og tyktarmen med skader på slimhinden (pseudomembranøs colitis), forårsaget af bakterien Clostridium difficile.
English: 4 to 6 weeks***
Danish: 4 til 6 uger ***
English: Drug fever, shivering, Pain and muscle spasm of the chest and back muscles
Danish: Lægemiddelinduceret feber, kulderystelser, smerter og muskelkramper i brystet og rygmusklerne
English: When vancomycin is administered parenterally, the most common adverse reactions are phlebitis, pseudo-allergic reactions and flushing of the upper body (“red-neck syndrome”) in connection with too rapid intravenous infusion of vancomycin.
Danish: Når vancomycin administreres parenteralt, er de mest almindelige bivirkninger flebitis, pseudoallergiske reaktioner og rødmen på overkroppen ("red man syndrome") i forbindelse med for hurtig intravenøs infusion af vancomycin.
English: Vancomycin is used in adults and adolescents from 12 years of age for the treatment of infections of the mucosa of the small and the large intestines with damage to the mucosae (pseudomembranous colitis), caused by the Clostridium difficile bacterium.
Danish: Vancomycin anvendes til voksne og unge fra 12 år og derover til behandling af infektioner i slimhinden i tynd- og tyktarmen med skader på slimhinden (pseudomembranøs colitis), forårsaget af bakterien Clostridium difficile.
English: Vancomycin is a tricyclic glycopeptide antibiotic that inhibits the synthesis of the cell wall in sensitive bacteria by binding with high affinity to the D-alanyl-D-alanine terminus of cell wall precursor units.
Danish: Vancomycin er et tricyklisk glykopeptidantibiotikum, der hæmmer syntesen af cellevæggen i følsomme bakterier ved binding med høj affinitet til D-alanyl-D-alanin-terminalen af cellevæggens prækursorer.
English: 4.4 Special warnings and precautions for use [This section should read as follows:]
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende anvendelsen [Dette afsnit skal lyde som følger:]
English: Vascular disorders: Common
Danish: Vaskulære sygdomme: Almindelig
English: 4 to 6 weeks**
Danish: 4 til 6 uger **
English: Amendments to relevant sections of the summary of product characteristics and the package leaflets
Danish: Ændringer i relevante punkter i produktresuméerne og indlægssedlerne Bemærk:
English: The combination of vancomycin with a cephalosporin has a synergistic effect against some oxacillin-resistant Staphylococcus epidermidis strains, and the combination of vancomycin with rifampicin has a synergistic effect against Staphylococcus epidermidis and a partial synergistic effect against some Staphylococcus aureus strains.
Danish: Kombinationen af vancomycin og et cefalosporin har en synergistisk virkning mod nogle oxacillin-resistente Staphylococcus epidermidis-stammer, og kombinationen af vancomycin og rifampicin har en synergistisk virkning mod Staphylococcus epidermidis og en delvis synergistisk virkning mod nogle Staphylococcus aureus-stammer.
English: Similarly, concomitant use with other medicines such as aminoglycoside antibiotics, nonsteroidal anti-inflammatory agents (NSAIDs, e.g., ibuprofen) or amphotericin B (medicine for fungal infection) can increase the risk of kidney damage and therefore more frequent blood and renal test may be necessary.
Danish: Ligeledes kan samtidig anvendelse med andre lægemidler såsom aminoglykosidantibiotika, non-steroide antiinflammatoriske midler (NSAID'er, fx ibuprofen) eller amphotericin B (lægemiddel mod svampeinfektion) øge risikoen for nyreskader.
English: Hypersensitivity to the active substance or to any of the excipients (see section 4.4).
Danish: Overfølsomhed over for det aktive stof eller et eller flere af hjælpestofferne anført i punkt 6.1 (se punkt 4.4).
English: 4 to 6 weeks*
Danish: 4 til 6 uger *
English: Drug interactions with anaesthetic agents
Danish: Lægemiddelinteraktioner med anæstetika
English: [For parenteral formulations authorised for oral use:] The absorption of vancomycin from the gastrointestinal tract is negligible.
Danish: [For parenterale formuleringer godkendt til oral anvendelse:] Optagelsen af vancomycin fra mave-tarm-kanalen er ubetydelig.
English: Anaesthetic induced myocardial depression may be enhanced by vancomycin.
Danish: Vancomycin kan forstærke myokardiedepression induceret af anæstesi.
English: How to use [product name]
Danish: Brug ikke [handelsnavn]
English: This may lead to vancomycin accumulation in patients with co-existing renal impairment.
Danish: Dette kan føre til akkumulering af vancomycin hos patienter med samtidig nedsat nyrefunktion.
English: Serial tests of auditory function may be helpful in order to minimise the risk of ototoxicity in patients with an underlying hearing loss, or who are receiving concomitant therapy with an ototoxic agent such as an aminoglycoside.
Danish: Løbende tests af auditiv funktion kan være nyttige for at minimere risikoen for ototoksicitet hos patienter med et underliggende høretab, eller som får samtidig behandling med et ototoksisk middel så som et aminoglykosid.
English: Patients aged 12 years and older
Danish: Patienter på 12 år og derover
English: Vancomycin should be used with particular care in premature neonates and young infants, because of their renal immaturity and the possible increase in the serum concentration of vancomycin.
Danish: Vancomycin bør anvendes med særlig forsigtighed hos præmature nyfødte og spædbørn, fordi deres nyrer ikke er fuldt udviklede, hvorfor serumkoncentrationen af vancomycin kan være højere.
English: [For parenteral formulations authorised for perioperative antibacterial prophylaxis, include the wording as follows:]
Danish: [For parenterale formuleringer godkendt til perioperativ antibakteriel profylakse skal følgende ordlyd inkluderes:]
English: [For all vancomycin 1000 mg powder for concentrate for solution for infusion, the following wording to be reflected in this section]
Danish: [For alle vancomycin 1000 mg pulver til koncentrat til infusionsvæske, opløsning, skal følgende ordlyd afspejles i dette afsnit]
English: Serial monitoring of renal function should be performed when treating patients with underlying renal dysfunction or patients receiving concomitant therapy with an aminoglycoside or other nephrotoxic drugs.
Danish: Nyrefunktionen skal monitoreres løbende ved behandling af patienter med underliggende nyresvigt eller patienter, der får samtidig behandling med et aminoglykosid eller andre nefrotoksiske lægemidler.
English: 1 - Use antibiotics only when prescribed.
Danish: For at bevare virkningen af dette lægemiddel er det derfor vigtigt, at du: 1 - kun anvender antibiotika, når du får dem ordineret.
English: PMA (weeks) Dose (mg/kg) Interval of administration (h)
Danish: Dosis (mg/kg)
English: Talk to your doctor or hospital pharmacist or nurse during treatment with Vancomycin if: - You are receiving vancomycin for a long time (you may need to have your blood, hepatic and kidneys tested during treatment).
Danish: Tal med lægen, apotekspersonalet eller sundhedspersonalet under behandlingen med vancomycin, hvis: - du får vancomycin igennem længere tid (det kan være nødvendigt at få dit blod, din lever og dine nyrer undersøgt under behandlingen) - du udvikler en hudreaktion under behandlingen - du udvikler alvorlig eller langvarig diarré under eller efter anvendelse af vancomycin; hvis det sker, skal du straks kontakte din læge.
English: Susceptibility testing breakpoints
Danish: Resistensbestemmelse breakpoints
English: [For parenteral formulations authorised for intraperitoneal use:] Intraperitoneal administration
Danish: [For parenterale formuleringer godkendt til intraperitoneal anvendelse:] Intraperitoneal indgivelse
English: Vancomycin capsules are indicated in patients 12 years and older for the treatment of Clostridium difficile infection (CDI) (see sections 4.2, 4.4 and 5.1).
Danish: Vancomycin kapsler er indiceret hos patienter fra 12 år og ældre til behandling af Clostridium difficile infektion (CDI) (se pkt.
English: Blood and the lymphatic system disorders: Rare
Danish: Systemorganklasse Hyppighed Bivirkning Blod og lymfesystem: Sjælden
English: Commonly susceptible species Gram positive
Danish: Arter, der almindeligvis er følsomme: Grampositive
English: [For parenteral formulations authorised for intraperitoneal use:] If given for the treatment of of infections related to peritoneal dialysis, vancomycin will be added to the dialysate solution in the long-dwell exchange.
Danish: [For parenterale formuleringer godkendt til intraperitoneal anvendelse:] Ved anvendelse til behandling af infektioner relateret til peritonealdialyse vil vancomycin blive tilsat til dialysatopløsningen i forbindelse med dialyse, hvor dialysevæsken forbliver i bughulen i lang tid (long dwell-dialyse).
English: Monitoring of serum vancomycin concentrations of patients with inflammatory disorders of the intestinal mucosa should be performed.
Danish: Vancomycinkoncentrationerne i serum hos patienter med inflammatoriske sygdomme i tarmslimhinden skal monitoreres.
English: [For all vancomycin 250 mg capsule] <{(Invented) vancomycin 250mg capsule}>
Danish: [For alle vancomycin 250 mg kapsler] <{(Handelsnavn) vancomycin 250 mg kapsel}>
English: Skin and subcutaneous tissue disorders: Common
Danish: Hud og subkutane væv:
English: Monitoring vancomycin serum concentrations after oral administration in patients with inflammatory intestinal disorders should be performed (see section 4.4).
Danish: Serumkoncentrationerne af vancomycin efter oral administration til patienter med inflammatoriske tarmlidelser bør monitoreres (se pkt.
English: 4.3 Contraindications [This section should read as follows:]
Danish: 4.3 Kontraindikationer [Dette afsnit skal lyde som følger:]
English: NAME OF THE MEDICINAL PRODUCT [For all vancomycin 125 mg capsule] <{(Invented) vancomycin 125mg capsule}> [For all vancomycin 250 mg capsule] <{(Invented) vancomycin 250mg capsule}>
Danish: LÆGEMIDLETS NAVN [For alle vancomycin 125 mg kapsler] <{Handelsnavn) vancomycin 125 mg kapsel}> [For alle vancomycin 250 mg kapsler] <{(Handelsnavn) vancomycin 250 mg kapsel}>
English: [For all vancomycin 125 mg capsule] <{(Invented) vancomycin 125mg capsule}>
Danish: [For alle vancomycin 125 mg kapsler] <{(Handelsnavn) vancomycin 125 mg kapsel}>
English: Vancomycin capsules are not appropriate for children under 12 years or for adolescents unable to swallow them.
Danish: Vancomycin kapsler er ikke egnet til børn under 12 år eller til unge, der ikke er i stand til at sluge dem. Andre typer af dette lægemiddel kan være bedre egnet til børn.
English: No dose adjustment is needed in patients with hepatic insufficiency.
Danish: Nedsat leverfunktion: Ingen dosisjustering er nødvendig hos patienter med nedsat leverfunktion.
English: However, if you have an inflammatory disorder of the digestive tract, especially if you also have a kidney disorder, similar side effects as those that occur when vancomycin is given by infusion may appear.
Danish: Hvis du har en betændelsessygdom i fordøjelseskanalen, især hvis du også har en nyresygdom, kan der dog forekomme bivirkninger som dem, der opstår, når vancomycin gives som infusion.
English: Each vial contains 1000 mg contains vancomycin hydrochloride equivalent to 1,000,000 IU vancomycin.
Danish: Hvert hætteglas indeholder 1000 mg vancomycin svarende til 1.000.000 IE vancomycin.
English: Bone and joint infections
Danish: Knogle- og ledinfektioner
English: Very rare side effects (may affect up to 1 in 10,000 people):
Danish: Almindelige bivirkninger (kan forekomme hos 1 ud af 10 personer): - Fald i blodtryk
English: Each vial contains 500 mg vancomycin hydrochloride equivalent to 500,000 IU vancomycin.
Danish: Hvert hætteglas indeholder 500 mg vancomycin svarende til 500.000 IE vancomycin.
English: 4.2 Posology and method of administration [This section should read as follows:]
Danish: 4.2 Dosering og indgivelsesmåde [Dette afsnit skal lyde som følger:]
English: Oral administration [This section must include instructions for preparation and administration of the oral solution.
Danish: [For parenterale formuleringer godkendt til oral administration, skal følgende afspejles i dette afsnit] Oral administration [Dette punkt skal omfatte instruktioner til forberedelse og indgivelse af den orale opløsning.
English: Very rare side effects (may affect up to 1 in 10,000 people): - Sudden onset of severe allergic skin reaction with skin flaking blistering or peeling skin.
Danish: Meget sjældne bivirkninger (kan forekomme hos op til 1 ud af 10.000 personer): - Pludseligt udbrud af alvorlig allergisk hudreaktion med skællende, blæredannende hud; kan være ledsaget af høj feber og ledsmerter - Hjertestop - Betændelse i tarmen, der giver mavesmerter og diarré, som kan indeholde blod.
English: Vancomycin is indicated in all age groups for the treatment of peritoneal dialysis-associated peritonitis (see sections 4.2, 4.4 and 5.1).
Danish: Vancomycin er indiceret til alle aldersgrupper til behandling af peritonealdialyseassocieret peritonitis (se pkt.
English: Susceptible ≤ 2 mg/L
Danish: følsom ≤ 2 mg/l
English: The absorption of vancomycin from the gastrointestinal tract is negligible.
Danish: Absorptionen af vancomycin fra mave-tarm-kanalen er ubetydelig.
English: Gram positive aerobic species Erysipelothrix rhusiopathiae, Heterofermentative Lactobacillus, Leuconostoc spp
Danish: Heterofermentative Lactobacillus, Leuconostoc spp
English: Eosinophilia and systemic symptoms (DRESS syndrome), AGEP (Acute Generalized Exanthematous Pustulosis) Renal and urinary disorders: Common
Danish: AGEP (akut generaliseret eksantematøs pustulose) Nyrer og urinveje:
English: Absorption may be enhanced in patients with inflammatory disorders of the intestinal mucosa or Clostridium difficile-induced pseudomembranous colitis.
Danish: Absorption kan forøges hos patienter med inflammatoriske sygdomme i tarmslimhinden eller Clostridium difficile-induceret pseudomembranøs colitis.
English: However, absorption may be enhanced in patients with inflammatory disorders of the intestinal mucosa or with Clostridium difficile-induced pseudomembranous colitis.
Danish: Imidlertid kan absorption forøges hos patienter med inflammatoriske sygdomme i tarmslimhinden eller med Clostridium difficileinduceret pseudomembranøs colitis.
English: Common side effects (may affect up to 1 in 10 people): - Fall in blood pressure - Breathlessness, noisy breathing (a high pitched sound resulting from obstructed air flow in the upper airway) - Rash and inflammation of the lining of the mouth, itching, itching rash, hives - Kidney problems which may be detected primarily by blood tests - Redness of upper body and face, inflammation of a vein Uncommon side effects (may affect up to 1 in 100 people): - Temporary or permanent loss of hearing
Danish: Almindelige bivirkninger (kan forekomme hos 1 ud af 10 personer): - Fald i blodtryk - Stakåndethed, støjende vejrtrækning (en høj lyd som følge af besværet luftgennemstrømning i de øvre luftveje) - Udslæt og betændelse i munden, kløe, kløende udslæt, nældefeber - Nyreproblemer, der primært kan påvises ved blodprøver - Rødmen på overkrop og ansigt, venebetændelse.
English: [For parenteral formulations authorised for oral administration, the following should be reflected in this section]
Danish: [For parenterale formuleringer godkendt til oral anvendelse, bør følgende afspejles i dette afsnit] Oral Administration
English: Cardiac disorders Very rare
Danish: Hjerte: Meget sjælden
English: NAME OF THE MEDICINAL PRODUCT [For all vancomycin 500 mg powder for concentrate for solution for infusion] <{(Invented) vancomycin 500mg powder for concentrate for solution for infusion}>
Danish: LÆGEMIDLETS NAVN [For alle vancomycin 500 mg pulver til koncentrat til infusionsvæske, opløsning] <{(Handelsnavn) vancomycin 500 mg pulver til koncentrat til infusionsvæske, opløsning}>
English: Possible side effects [This section should read as follows:]
Danish: Bivirkninger [Dette afsnit skal lyde som følger:]
English: Vancomycin is indicated in all age groups for the treatment of Clostridium difficile infection (CDI) (see sections 4.2, 4.4 and 5.1).
Danish: Vancomycin er indiceret til alle aldersgrupper til behandling af Clostridium difficile-infektion (CDI) (se pkt.
English: The usual infusion dose is 10 to 15 mg for each kg of body weight.
Danish: Den sædvanlige infusionsdosis er 10 til 15 mg pr. kg legemsvægt og gives normalt hver 6. time.
English: - Kidney problems which may be detected primarily by blood tests - Redness of upper body and face, inflammation of a vein Uncommon side effects (may affect up to 1 in 100 people): - Temporary or permanent loss of hearing
Danish: Ikke almindelige bivirkninger (kan forekomme hos 1 ud af 100 personer): - Midlertidigt eller permanent tab af hørelse.
English: [For all vancomycin 1000 mg powder for concentrate for solution for infusion] <{(Invented) vancomycin 1000mg powder for concentrate for solution for infusion}>
Danish: [For alle vancomycin 1000 mg pulver til koncentrat til infusionsvæske, opløsning] <{(Handelsnavn) vancomycin 1000 mg pulver til koncentrat til infusionsvæske, opløsning}>
English: [For parenteral formulations authorised for oral use, include the wording as follows:]
Danish: [For parenterale formuleringer godkendt til oral anvendelse, skal følgende ordlyd anvendes:]
English: - Infection in the blood linked to the infections listed above.
Danish: når der foretages større kirurgiske indgreb - betændelse i centralnervesystemet - betændelse i blodet forbundet med de betændelser, der er anført ovenfor.
English: [For parenteral formulations authorised for intraperitoneal administration, include the wording as follows:]
Danish: [For parenterale formuleringer godkendt til intraperitoneal administration, skal følgende ordlyd inkluderes:]
English: The usual infusion dose is 15 to 20 mg for each kg of body weight.
Danish: Den sædvanlige infusionsdosis er 15 til 20 mg pr. kg legemsvægt og gives normalt hver 8. til 12. time.
English: [For all vancomycin 500 mg powder for concentrate for solution for infusion] <{(Invented) vancomycin 500mg powder for concentrate for solution for infusion}>
Danish: [For alle vancomycin 500 mg pulver til koncentrat til infusionsvæske, opløsning] <{(Handelsnavn) vancomycin 500 mg pulver til koncentrat til infusionsvæske, opløsning}>
English: This may be associated with a high fever and joint pains - Cardiac arrest - Inflammation of the bowel which causes abdominal pain and diarrhea, which may contain blood Not known (frequency cannot be estimated from the available data): - Being sick (throwing up), diarrhoea - Confusion, drowsiness, lack of energy, swelling, fluid retention, decreased urine - Rash with swelling or pain behind the ears, in the neck, groin, under the chin and armpits (swollen lymph nodes), abnormal blood and liver function tests - Rash with blisters and fever.
Danish: Ikke kendt (hyppighed kan ikke estimeres ud fra forhåndenværende data): - Opkastninger, diarré - Forvirring, døsighed, mangel på energi, hævelse, væskeophobning, nedsat vandladning - Udslæt med hævelse eller smerter bag ørerne, i nakken, lysken, under hagen og armhulen