FrancophonIA/ELRC3.0 huggingface dataset:
English: Targocid and associated names (see Annex I) has minor influence on the ability to drive and use machines.
Danish: Targocid og relaterede navne (Se bilag I) påvirker kun i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: This medicine is for single use only.
Danish: Lægemidlet er kun til engangsbrug.
English: Pharmacotherapeutic group: Glycopeptide Antibacterials, ATC code: J01XA 02
Danish: Farmakoterapeutisk klassifikation: Glykopeptider, antibakterielle midler, ATC-Kode: J01XA 02
English: Teicoplanin antimicrobial activity depends essentially on the duration of time during which the substance level is higher than the minimum inhibitory concentration (MIC) of the pathogen.
Danish: Antimikrobiel teicoplanin-aktivitet afhænger hovedsageligt af varigheden af den periode, hvor koncentrationen af stoffet er højere end patogenets mindste hæmmende koncentration (MIC).
English: The freeze-dried medicinal product is packaged in:
Danish: Det frysetørrede lægemiddel er pakket i:
English: Infusion related reactions
Danish: Infusionsrelaterede reaktioner
English: Unchanged teicoplanin is mainly excreted by urinary route (80% within 16 days) while 2.7% of the administered dose is recovered in feces (via bile excretion) within 8 days following administration.
Danish: Uomdannet teicoplanin udskilles hovedsageligt via urinvejene (80 % inden for 16 dage), mens 2,7 % af den indgivne dosis genfindes i fæces (via galdeudskillelse) indenfor 8 dage efter administration.
English: If teicoplanin is administered in combination therapy with other antibiotics, the preparation must be administered separately.
Danish: Hvis teicoplanin administreres i kombinationsbehandling med andre antibiotika, skal præparatet administreres separat.
English: d A MIC with a comment but without an accompanying S, I or R categorisation may be reported.
Danish: d Et MIC med en kommentar, men uden en ledsagende S (følsom)-, I (intermediær)- eller R (resistent)-kategorisering, kan indberettes.
English: • Peritoneal dialysis solution containing 1.36% or 3.86% glucose solution.
Danish: • Peritonealdialyseopløsning indeholdende 1,36 % eller 3,86 % glucose.
English: After intramuscular administration, the bioavailability of teicoplanin (as compared to intravenous administration) is almost complete (90%).
Danish: Efter intramuskulær administration er teicoplanins biotilgængelighed næsten fuldstændig (90 %, sammenlignet med intravenøs administration).
English: You may have headaches or feel dizzy while being treated with Targocid.
Danish: Du kan få hovedpine eller blive svimmel under behandling med Targocid.
English: A potential risk of inner ear and renal damage to the foetus cannot be excluded (see section 4.4).
Danish: En potentiel risiko for skader på fosterets indre øre og nyrer kan ikke udelukkes (se pkt.
English: The recommended dose is
Danish: Den sædvanlige dosis er
English: Resistance rate can vary depending on the actual streptococcus species
Danish: Resistenshyppigheden kan variere alt efter den aktuelle streptokok-art.
English: However, a prior history of "red man syndrome" with vancomycin is not a contraindication to the use of teicoplanin.
Danish: Dog er en anamnese med red man-syndromet ved vancomycin ikke kontraindikation for brug af teicoplanin.
English: Targeted trough concentrations at day 3 to 5
Danish: Startdosisregime Mål for dalkoncentrationen på dag 3 til 5
English: Where appropriate, teicoplanin should be administered in combination with other antibacterial agents.
Danish: Hvor det er relevant, bør teicoplanin administreres i kombination med andre antibakterielle midler.
English: Adults and children (12 years and over) with no kidney problems Skin and soft tissue, lung and urinary tract infections
Danish: Voksne og børn (12 år og derover) uden nyreproblemer Infektioner i hud og blødt væv, lunger og urinveje
English: Teicoplanin has a limited spectrum of antibacterial activity (Gram positive).
Danish: Teicoplanin har et begrænset spektrum for antibakteriel aktivitet (grampositiv).
English: Teicoplanin is mainly bound to human serum albumin.
Danish: Teicoplanin er hovedsageligt bundet til humant serumalbumin.
English: 4.2 Posology and method of administration
Danish: 4.2 Dosering og administrationsmåde
English: • The reduced sensitivity or resistance of staphylococci to teicoplanin is based on the overproduction of murein precursors to which teicoplanin is bound.
Danish: • Stafylokokkers nedsatte følsomhed eller resistens over for teicoplanin er baseret på overproduktion af mureinforstadier, som teicoplanin er bundet til.
English: A number of vancomycin-resistant enterococci are sensitive to teicoplanin (Van-B phenotype).
Danish: En række vancomycin-resistente enterokokker er følsomme for teicoplanin (Van-B-fænotype).
English: Staphylococcus aureus (including methicillin-resistant strains) Streptococcus agalactiae
Danish: Staphylococcus aureus (inklusive methicillinresistente stammer) Streptococcus agalactiae
English: There may be a potential risk of inner ear and kidney problems.
Danish: Der kan muligvis være en risiko for problemer i det indre øre samt nyreproblemer.
English: It is unknown whether teicoplanin is excreted in human milk.
Danish: Det er ukendt, om teicoplanin udskilles i human mælk.
English: Babies (from birth to the age of 2 months)
Danish: Babyer (fra fødslen til en alder på 2 måneder)
English: Teicoplanin does not readily penetrate into the cerebrospinal fluid (CSF).
Danish: Teicoplanin trænger ikke hurtigt ind i cerebrospinalvæsken (CSF).
English: • kidney problems or changes in the way your kidneys work - shown in tests
Danish: • nyreproblemer eller ændringer i nyrernes funktion - påvist ved prøver
English: The solvent is a clear and colourless solution.
Danish: Solvens er klart og farveløst.
English: In rare cases (even at the first dose), red man syndrome (a complex of symptoms including pruritus, urticaria, erythema, angioneurotic oedema, tachycardia, hypotension, dyspnoea) has been observed.
Danish: I sjældne tilfælde (selv ved den første dosis) er red man-syndromet (et kompleks af symptomer, herunder pruritus, urticaria, erytem, angioødem, takykardi, hypotension, dyspnø) blevet observeret.
English: Children (2 months to 12 years):
Danish: Børn (2 måneder til 12 år):
English: Teicoplanin must be administered with caution in patients with known hypersensitivity to vancomycin, as crossed hypersensitivity reactions, including fatal anaphylactic shock, may occur.
Danish: Teicoplanin skal administreres med forsigtighed hos patienter med kendt overfølsomhed over for vancomycin, da kryds-overfølsomhedsreaktioner, inklusive dødeligt anafylaktisk shock, kan forekomme.
English: The powder is packaged:
Danish: Pulveret er pakket i:
English: In clinical studies, teicoplanin has been administered to many patients already receiving various medications including other antibiotics, antihypertensives, anaesthetic agents, cardiac medicinal products and antidiabetic agents without evidence of adverse interaction.
Danish: I kliniske studier er teicoplanin blevet givet til mange patienter, der allerede får forskellige lægemidler, herunder andre antibiotika, antihypertensiva, anæstetika, kardiologiske lægemidler og antidiabetika uden tegn på uønsket interaktion.
English: Targocid can be used to treat some infections caused by ‘Clostridium difficile' bacteria in the gut.
Danish: Targocid kan anvendes til behandling af visse infektioner forårsaget af tarmbakterien Clostridium difficile.
English: Superinfection
Danish: Superinfektion
English: • sodium chloride 9 mg/mL (0.9%) solution
Danish: • natriumchlorid 9 mg/ml (0,9 %) opløsning
English: Infusion related reactions can be limited if the daily dose is not given via bolus injection but infused over a 30-minute period.
Danish: Infusionsrelaterede reaktioner kan begrænses, hvis den daglige dosis ikke gives som bolusinjektion, men som infusion over 30 minutter.
English: During maintenance treatment, teicoplanin trough serum concentrations monitoring may be performed at least once a week to ensure that these concentrations are stable.
Danish: Under vedligeholdelsesbehandling bør dalværdien af teicoplanin måles mindst en gang om ugen for at sikre, at koncentrationen er stabil.
English: Adults and elderly patients with normal renal function
Danish: Voksne og ældre patienter med normal nyrefunktion
English: >15 mg/L once a week
Danish: >15 mg/l én gang ugentligt
English: • It will be given by injection into a vein (intravenous use) or muscle (intramuscular use).
Danish: • Lægemidlet gives ved injektion i en vene (intravenøst) eller muskel (intramuskulært).
English: EXP Read the leaflet for the shelf life of the reconstituted medicine.
Danish: EXP Læs indlægssedlen angående opbevaringstid af det rekonstituerede lægemiddel.
English: Spectrum of antibacterial activity
Danish: Antibakterielt spektrum
English: They may also cause hearing problems and/or kidney problems.
Danish: De kan også forårsage høreproblemer og/eller nyreproblemer.
English: Renal failure (including renal failure acute)
Danish: Nyresvigt (inklusive akut nyresvigt)
English: Elderly population No dose adjustment is required, unless there is renal impairment (see below).
Danish: Ældre patienter Dosisjustering er ikke nødvendig, medmindre nyrefunktionen er nedsat (se nedenfor).
English: Teicoplanin has a low total clearance in the range of 10 to 14 mL/h/kg and a renal clearance in the range of 8 to 12 mL/h/kg indicating that teicoplanin is mainly excreted by renal mechanisms.
Danish: Teicoplanin har en lav total clearance i området 10 til 14 ml/t/kg og renal clearance i området fra 8 til 12 ml/t/kg, hvilket indikerer, at teicoplanin hovedsageligt udskilles ved renale mekanismer.
English: Measurement of serum concentrations
Danish: Serumkoncentrationsmålinger
English: If you are pregnant, think that you might be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before being given this medicine.
Danish: Hvis du er gravid, tror, at du kan være gravid, eller planlægger at blive gravid, så spørg lægen, apotekspersonalet eller sundhedspersonalet til råds, før du får dette lægemiddel.
English: Rare (may affect up to 1 in 1,000 people) • infection (abcess).
Danish: Sjældne (kan påvirke op til 1 ud af 1.000 personer) • infektion (absces).
English: This SmPC, labelling and packages leaflet is the version valid at the time of Commission decision.
Danish: Dette produktresumé samt denne mærkning og indlægsseddel er gyldige på tidspunktet for Kommissionens afgørelse.
English: However, if you think you have been given too much Targocid or if you are agitated, talk to your doctor or nurse straight away.
Danish: Hvis du tror, du har fået for meget Targocid, eller hvis du er urolig, så tal med din læge eller sygeplejerske med det samme.
English: Teicoplanin and aminoglycoside are incompatible when mixed directly and must not be mixed before injection.
Danish: Teicoplanin og aminoglykosider er inkompatible, når de blandes direkte, og må ikke blandes før injektion.
English: What you need to know before you are given Targocid 3.
Danish: Det skal du vide, før du begynder at bruge Targocid 3.
English: Common (≥1/100 to
Danish: (≥1/100 til
English: Linearity Teicoplanin exhibited linear pharmacokinetics at dose range of 2 to 25 mg/kg.
Danish: Linearitet Teicoplanin udviste lineær farmakokinetik i dosisintervallet fra 2 til 25 mg/kg.
English: Patients in continuous ambulatory peritoneal dialysis (CAPD) After a single intravenous loading dose of 6 mg/kg bodyweight, 20 mg/L is administered in the bag of the dialysis solution in the first week, 20 mg/L in different bags the second week and then 20 mg/L in the overnight bag in the third week.
Danish: Patienter i kontinuerlig ambulant peritonealdialyse (CAPD) Efter en enkelt intravenøs startdosis på 6 mg/kg legemsvægt administreres 20 mg/l i posen med dialysevæske den første uge, 20 mg/l i hver anden pose den anden uge og derefter 20 mg/l i natposen i den tredje uge.
English: Transaminases increased (transient abnormality of transaminases), blood alkaline phosphatase increased (transient abnormality of alkaline phosphatase), blood creatinine increased (transient rise of serum creatinine)
Danish: Forhøjede aminotransferaser (forbigående abnormitet i aminotransferaser forhøjet basisk fosfatase i blodet (forbigående abnormitet af alkalisk fosfatase), forhøjet blodkreatinin (forbigående stigning i serumkreatinin)
English: • you have a kidney problem
Danish: • du har nyreproblemer
English: Thrombocytopenia has been reported with teicoplanin.
Danish: Trombocytopeni er blevet rapporteret med teicoplanin.
English: Also, some medicines can affect the way Targocid works.
Danish: Desuden kan nogle lægemidler påvirke Targocids virkning.
English: Species for which acquired resistance may be a problem Aerobic Gram-positive bacteria Enterococcus faecium
Danish: Arter, hvor erhvervet resistens kan udgøre et problem Aerobe grampositive bakterier Enterococcus faecalis
English: Fertility Animal reproduction studies have not shown evidence of impairment of fertility.
Danish: Fertilitet Reproduktionsstudier hos dyr har ikke vist tegn på nedsat fertilitet.
English: • The active substance is teicoplanin.
Danish: • Aktivt stof: teicoplanin.
English: Elimination of teicoplanin from peritoneal fluid occurs at the same rate as from serum.
Danish: Eliminering af teicoplanin fra peritonealvæsken sker med samme hastighed som fra serum.
English: Studies to investigate the potential to cause ototoxicity in the guinea-pig indicate that a mild impairment of cochlear and vestibular function is possible, in the absence of morphological damage.
Danish: Studier, som undersøgte potentialet for ototoksicitet hos marsvin, indikerer, at en svag forringelse af den kokleære og vestibulære funktion uden morfologiske skader kan forekomme.
English: Peptidoglycan synthesis is blocked by specific binding to D-alanyl-D-alanine residues.
Danish: Peptidglykansyntesen blokeres ved specifik binding til D-alanyl-D-alanin.
English: Targocid and associated names (see Annex I) is also indicated as an alternative oral treatment for Clostridium difficile infection-associated diarrhoea and colitis.
Danish: Targocid og relaterede navne (Se bilag I) er også indiceret som en alternativ oral behandling af Clostridium difficile-infektion i forbindelse med diarré og colitis.
English: Pharmacokinetic/Pharmacodynamic relationship
Danish: Farmakokinetiske/farmakodynamiske forhold
English: Targocid contains sodium This medicine contains less than 1 mmol sodium (23 mg) per vial and is essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) per hætteglas, og er stort set ”natriumfrit".
English: However, in the rat, there was an increased incidence of stillbirths at doses of 100 mg/kg/day and above and neonatal mortality at 200 mg/kg/day.
Danish: Hos rotter var der dog en øget forekomst af dødfødsler ved doser på 100 mg/kg/dag og derover og af neonatal mortalitet ved 200 mg/kg/dag.
English: Disposal Any unused medicine or waste material should be disposed of in accordance with local requirements.
Danish: Bortskaffelse Alt ubrugt lægemiddel og restmaterialer skal bortskaffes i overensstemmelse med lokale forskrifter.
English: Since data on safety are limited, patients should be carefully monitored for adverse reactions when teicoplanin doses of 12mg/kg body weight twice a day are administered.
Danish: Da sikkerhedsdata er begrænsede, skal patienterne monitoreres nøje for bivirkninger, når der gives teicoplanin-doser på 12 mg/kg legemsvægt to gange dagligt.
English: Toxic epidermal necrolysis,
Danish: Toksisk epidermal nekrolyse,
English: Only the infusion should be given in babies from birth to the age of 2 months.
Danish: Må kun administreres som infusion til babyer fra fødslen til en alder på 2 måneder.
English: Other medicines and Targocid
Danish: Brug af anden medicin sammen med Targocid
English: The reconstituted solution may also be given by mouth.
Danish: Den rekonstituerede opløsning kan også gives oralt.
English: 0.18% sodium chloride and 4% glucose solution 0.45% sodium chloride and 5% glucose solution Peritoneal dialysis solution containing 1.36% or 3.86% glucose solution.
Danish: 0,18 % natriumchlorid- og 4 % glucose-injektionsvæske 0,45 % natriumchlorid- og 5 % glucose-injektionsvæske Peritonealdialysevæsker indeholdende 1,36 % eller 3,86 % glucose.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Danish: Hvis det ikke anvendes straks, er opbevaringstid og betingelser før brug brugerens ansvar og vil normalt ikke være længere end 24 timer ved 2 til 8 °C, medmindre rekonstitution har fundet sted under kontrollerede og validerede aseptiske forhold.
English: • epileptic fits Tell your doctor or nurse straight away, if you notice any of the side effects above.
Danish: • epileptiske anfald Fortæl det til lægen eller sundhedspersonalet med det samme, hvis du bemærker nogen af de ovennævnte bivirkninger.
English: Adults and elderly patients with impaired renal function Dose adjustment is not required until the fourth day of treatment, at which time dosing should be adjusted to maintain a serum trough concentration of at least 10 mg/L.
Danish: Dosisjustering er ikke påkrævet før den fjerde behandlingsdag, på hvilket tidspunkt doseringen skal justeres for at opretholde en dalkoncentration på mindst 10 mg/l.
English: The reconstituted solution may be injected directly or alternatively further diluted.
Danish: Den rekonstituerede opløsning kan injiceres direkte eller alternativt fortyndes yderligere.
English: Teicoplanin trough serum concentrations should be monitored at steady state after completion of the loading dose regimen in order to ensure that a minimum trough serum concentration has been reached:
Danish: Dalværdien for serum-teicoplanin skal monitoreres ved steady state efter afslutning af startdosis for at sikre, at minimum-dalkoncentrationen i serum er nået:
English: • sudden life-threatening allergic reaction - the signs may include: difficulty in breathing or wheezing, swelling, rash, itching, fever, chills
Danish: • pludselig, livstruende allergisk reaktion - kendetegnene kan omfatte: vejrtrækningsbesvær eller hiven efter vejret, hævelse, udslæt, kløe, feber, kulderystelser
English: Gently roll the vial between the hands until the powder is completely dissolved.
Danish: Rul forsigtigt hætteglasset mellem hænderne, indtil pulveret er helt opløst.
English: - Infective endocarditis
Danish: • infektiøs endocarditis
English: Stevens-Johnson syndrome, erythema multiforme, angioedema, dermatitis exfoliative, urticaria (see section
Danish: Stevens-Johnsons syndrom, erythema multiforme, angioødem, eksfoliativ dermatitis, urticaria (se pkt.
English: Life-threatening or even fatal cutaneous reactions Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) have been reported with the use of teicoplanin.
Danish: Livstruende eller endda dødelige hudreaktioner, Stevens-Johnsons syndrom (SJS) og toksisk epidermal nekrolyse (TEN) er blevet rapporteret i forbindelse med brugen af teicoplanin.
English: Patients who develop signs and symptoms of impaired hearing or disorders of the inner ear during treatment with teicoplanin should be carefully evaluated and monitored, especially in case of prolonged treatment and in patients with renal insufficiency.
Danish: Patienter, som udvikler tegn og symptomer på nedsat hørelse eller lidelser i det indre øre under behandling med teicoplanin, skal vurderes omhyggeligt og monitoreres, især ved langvarig behandling eller ved nyreinsufficiens.
English: Resistant
Danish: Resistente
English: Studies in animals reproduction have not shown evidence of fertility problems.
Danish: Studier på dyr har ikke påvist tegn på problemer vedrørende frugtbarhed.
English: There is no information on the excretion of teicoplanin in animal milk.
Danish: Der er ingen information om udskillelse af teicoplanin i mælk hos dyr.
English: Teicoplanin is not distributed in red cells.
Danish: Teicoplanin fordeles ikke til røde blodlegemer.
English: Water for injections is packaged in Type I, colourless glass ampoule.
Danish: Vand til injektionsvæsker er pakket i type I, farveløs glasampul.
English: Diarrhoea, vomiting, nausea
Danish: Diarré, opkastning, kvalme
English: Measured by FPIA
Danish: Målt ved FPIA
English: It contains a medicine called ‘teicoplanin'.
Danish: Det indeholder et aktivt stof kaldet "teicoplanin".
English: • lack of white blood cells - the signs may include: fever, severe chills, sore throat or mouth ulcers (agranulocytosis)
Danish: • mangel på hvide blodlegemer - kendetegnene kan omfatte: feber, kraftige kulderystelser, ondt i halsen eller sår i munden (agranulocytose)
English: The solvent is packaged in Type I, colourless glass ampoule.
Danish: Solvens er pakket i Type I, farveløs glasampul.
English: As with other glycopeptides, ototoxicity (deafness and tinnitus) has been reported in patients treated with teicoplanin (see section 4.8).
Danish: Som med andre glykopeptider er ototoksicitet (døvhed og tinnitus) blevet rapporteret hos patienter behandlet med teicoplanin (se pkt.
English: Preparation of reconstituted solution: Slowly inject the entire content of the supplied solvent into the powder vial.
Danish: Klargøring af rekonstitueret opløsning: Injicer langsomt hele indholdet i ampullen med den medfølgende solvens ind i hætteglasset med pulver.
English: • The other ingredients are sodium chloride and sodium hydroxide.
Danish: • Øvrige indholdsstoffer: natriumchlorid og natriumhydroxid.
English: Unchanged form of teicoplanin is the main compound identified in plasma and urine, indicating minimal metabolism.
Danish: Teicoplanin er hovedsageligt identificeret som uomdannet stof i plasma og urin, hvilket indikerer minimal metabolisering.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis det ikke anvendes straks, er opbevaringstiden og betingelser før brug brugerens ansvar og vil normalt ikke være længere end 24 timer ved 2 til 8 °C, medmindre rekonstitution har fundet sted under kontrollerede og validerede aseptiske forhold.
English: Teicoplanin should be used with care in conjunction with or sequentially with other medicinal products with known nephrotoxic or ototoxic potential.
Danish: Teicoplanin skal anvendes med forsigtighed samtidig med eller sekventielt med andre lægemidler med kendt nefrotoksisk eller ototoksisk potentiale.
English: Nominal teicoplanin content of vial
Danish: Hætteglassets nominelle indhold af teicoplanin
English: Chemical and physical in-use stability of the reconstituted solution prepared as recommended has been demonstrated for 24 hours at 2 to 8°C.
Danish: Kemisk og fysisk stabilitet under brug af den rekonstituerede opløsning tilberedt som anbefalet er påvist i 24 timer ved 2 til 8 °C.
English: Blood and the lymphatic system disorders
Danish: Blod- og lymfesystem
English: • In mild and moderate renal insufficiency (creatinine clearance 30-80 mL/min): maintenance dose should be halved, either by administering the dose every two days or by administering half of this dose once a day.
Danish: • Ved let og moderat nyreinsufficiens (kreatininclearance 30-80 ml /min): Vedligeholdelsesdosis skal halveres, enten ved at administrere dosis hver anden dag eller ved at administrere den halve dosis én gang dagligt.
English: However, if you are worried, talk to your doctor or nurse.
Danish: Hvis du er bekymret, så tal med din læge eller sygeplejerske.
English: Talk to your doctor, pharmacist or nurse before you are given Targocid if:
Danish: Tal med lægen, apotekspersonalet eller sundhedspersonalet før du får Targocid, hvis: