Changes to teicoplanin prescribing on epma teicoplanin is a glycopeptide antibiotic active against grampositive bacteria only. Due to its long halflife, teicoplanin requires the administration of loading doses to achieve satisfactory serum levels. Dosing is individualised based on weight and renal function to achieve target predose trough levels. After the commission decision the member state competent authorities, in liaison with the reference member state, will update the product information as required. Targocid is a powder for solution for injectioninfusion or oral solution. Targocid article30 referral assessment report european. Envetec 200 series regulated waste management solutions. Teicoplanin dosing was prescribed based on the patients actual body weight. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert. Teicoplanin is an antibiotic used in the prophylaxis and treatment of serious infections caused by grampositive bacteria, including methicillinresistant staphylococcus aureus and enterococcus faecalis. Do not flush medications down the toilet or pour them into drainage unless instructed to do so. Sterile vancomycin hydrochloride, usp is a lyophilized powder, for preparing intravenous iv infusions. It does not take the place of talking to your doctor, or pharmacist. Adequate teicoplanin therapy referred to a loading dose of teicoplanin at 6 mgkg maximum 400 mg given three times 12 h apart, followed by maintenance dosing of 6 mgkg12 h or 6 mgkg24 h package insert, sanofiaventis.
Daptomycin versus teicoplanin for bloodstream infection due. The most advanced connectivity solution available for laboratory instrumentation. Department of health and human services public health service. Iamqc peer is an innovative, realtime, peer comparison software. Department of health and human services public health. Some health conditions may make you more susceptible to the sideeffects of the drug. Medication discarded in this manner may contaminate the environment. Etest application guide aerobes inoculum incubation recommended quality control organism specific phenotype media 6 mcf equivalent suspension medium. Targocid 400mg powder for solution for injectioninfusion or oral solution.
Qms teicoplanin qms teicoplanin calibrator set qms teicoplanin control set reagent 1. Staphylococcus aureus teicoplanin susceptible, coagulase negative staphylococci. In severe infections, trough serum concentrations should not be less than 10 mg per litre. Information for the user vancomycin mylan 500 mg, powder for concentrate for solution for infusion vancomycin mylan mg, powder for concentrate for solution for infusion vancomycin read all of this leaflet carefully before you start using this medicine because it contains important information for you. Peak concentrations measured one hour after a 400 mg intravenous dose are usually in the range of 20 to 50 mg per litre. Official website of the johns hopkins antibiotic abx, hiv, diabetes, and psychiatry guides, powered by unbound medicine. What is in this leaflet this leaflet answers some common questions about targocid. July 2016, b1797 ccp4057 correction of solvent scheduling, business address and inclusion of a in front of registration numbers, inclusion of inactive ingredients and sugar free statement. Outpatient parenteral antimicrobial therapy opat selfadministration of teicoplanin iv infusion this leaflet is designed to support patients, and nursing staff who are teaching patients to selfadminister teicoplanin, with the assistance of the opat team. Teicoplanin was the sole antimicrobial agent given in 269 of the 310 patients. Targocid 200mg powder for solution for injectioninfusion or. Targocid 400 mg lyophilised powder for injection with water for injections ampoule. The percentage of patients with a minimum concentration of drug in serum cmin. Teicoplanin is a topic covered in the johns hopkins abx guide.
Withdraw needles and syringes, discard in sharps bin. Clinically significant serum concentrations have been reported in some patients who have. Information strength of vials 200mg or 400mg diluent for reconstitution water for injection provided with drug volumes for reconstitution 3ml for both 200mg or 400mg administration give each intravenous injection slowly over 5 minutes. When reconstituted with sterile water for injection to a. Do not freeze medicines unless required by package insert. The standard dosing regimen 400 mg every 12 hr for 3 doses, then 400 mg once a day, iv recommended by the summary in the package insert of teicoplanin for severe infections has a tar of about 70% under steadystate ss conditions when c trough 10 mgl and auc 24 mic 125 were used as the therapeutic targets of teicoplanin. Orbactiv exerts a concentrationdependent bactericidal activity against s. Contents of the pack and other information 1 what teicoplanin is and what it is used for 2 what you need to know before you are given teicoplanin teicoplanin is an antibiotic, it contains a medicin e called teicoplanin. Eligible, privately insured patients may save on a qualifying.
Osteoporosis injection treatment forteo teriparatide. Targocid 100, 200 mg and 400 mg powder for solution for. Adequate teicoplanin therapy was defined as a loading dose of 6 mgkg administered thrice 12 hours apart,18 followed by a maintenance dose of 6 mgkg12 hours highdose teicoplanin group or 6 mgkg24 hours standarddose teicoplanin group or the adjusted equivalent doses for patients with impaired renal function according to the package. Page 3 of 5 do not receive dyna teicoplanin if you are pregnant, planning to become pregnant or breastfeeding. Etest is a wellestablished method for antimicrobial susceptibility testing in microbiology laboratories around the world. Targocid 1 targocid targosid teicoplanin teecoplanin consumer medicine information. Each monograph contains stability data, administration guidelines, and methods of preparation. Outpatient parenteral antimicrobial therapy opat self. Summary of product characteristics, labelling and package leaflet. List of approved drugs containing teicoplanin listed with health canada in the drug product database dpd.
It is a semisynthetic glycopeptide antibiotic with a spectrum of activity similar to vancomycin. Eligible, privately insured patients may save on a qualifying prescription with the savings coupon for. Use of teicoplanin in community medicine springerlink. Teicoplanin dosing strategy for treatment of staphylococcus. Before using teicoplanin, inform your doctor about your current list of medications, over the counter products e. Visual examination of finished product for teicoplanin and. When reconstituted as directed each 10 ml contains 500 mg and each 20 ml contains 1 gram.
Department of health and human services public health service food and drug administration center for drug evaluation and research office of surveillance and epidemiology. If the solution becomes foamy let stand for 15 minutes. Targocid 400mg powder for solution for injectioninfusion or oral. Its mechanism of action is to inhibit bacterial cell wall synthesis. Information for the user vancomycin hydrochloride 500 mg and 1 g powder for concentrate for infusion vancomycin hydrochloride read all of this leaflet carefully before you start using this medicine. Teicoplanin prescribing and therapeutic drug monitoring. Teicoplanin health canada drug product database dpd.
These highlights do not include all the information needed to use prolastin c. Aug 27, 2019 targocid is a powder for solution for injectioninfusion or oral solution. Johns hopkins guide app for ios, iphone, ipad, and android included. Package insert instructions must be followed accordingly. Teicoplanin inhibits polymerization of cell wall components in susceptible bacteria. Forteo is used in both men and women with osteoporosis due to use of glucocorticoid medicines, such as prednisone, for several months, who are at high risk for having broken bones, or fractures. What you need to know before you are given teicoplanin 3. The covariance matrix was inserted into subroutine prior. Annex iii summary of product characteristics, labelling. Intravenous admixtures preparation and infusion guidelines. Intravenous iv preparation and infusion guidelines globalrph. Adjust teicoplanin doses after the trough level is reported, do not withhold doses pending trough level reports. Teicoplanin prescribing and therapeutic drug monitoring clinical guideline v2. Qms teicoplanin, 0374645, leveres som en et brugsklart toreagenss.
Treatment of candidemia, acute disseminated candidiasis. The teicoplanin population pk is highly variable in children, with a wider auc. Dyna teicoplanin 200 mg is a whiteyellow lyophilised freezedried powder. Turn the bag upside down several times to ensure thorough mixing of the solution.
Determination of teicoplanin serum concentrations may optimise therapy. The oral dose recommendation for teicoplanin is 100400 mg by mouth every 12 hours for 10 days. Insert the iv giving set and prime the line until there is no air in the line. Information for the user teicoplanin 100 mg powder and solvent for solution for injection infusion or oral solution. The strengths of teicoplanin finished product are conventionally declared and. Treatment of candidemia, acute disseminated candidiasis, candida peritonitis and abscesses in adult and pediatric patients 4 months of age and older see clinical studies 14.
Population pharmacokinetics of teicoplanin in children ncbi. Teicoplanin is a glycopeptide antibiotic active against grampositive bacteria only. When dyna teicoplanin is reconstituted, it is a clear, yellowish solution. Teicoplanin is used in human medicine to treat serious infections, such as septicemia, endocarditis, bone and joint infections caused by grampositive bacteria resistant to other drugs, cystitis due to multidrugresistant enterococci and catheterassociated staphylococcal infections in neutropenic patients. To view the entire topic, please sign in or purchase a subscription. Intended use the qms teicoplanin assay is intended for the quantitative determination of teicoplanin. Dailymed vancomycin vancomycin hydrochloride injection. Forteo is a prescription medication used in both men and postmenopausal women with osteoporosis who are at high risk for having broken bones, or fractures. Teicoplanin is a topic covered in the johns hopkins abx guide to view the entire topic, please sign in or purchase a subscription official website of the johns hopkins antibiotic abx, hiv, diabetes, and psychiatry guides, powered by unbound medicine.
Information for the user 200 mg powder for do not use targocid if. Targocid 200mg powder for solution for injectioninfusion. If you have any further questions, ask your doctor or nurse. Teicoplanin jordan university of science and technology. Each pharmacy bulk package contains vancomycin hydrochloride equivalent to 5 grams of vancomycin base. Population pharmacokinetics of teicoplanin in children. The powder is spongy, ivory and coloured homogeneous mass. Etest consists of a predefined gradient of antibiotic concentrations on a plastic strip and is used to determine the minimum inhibitory concentration mic of antibiotics, antifungal agents and antimycobacterial agents. Vancomycin hydrochloride for injection, usp is an off white to buffcolored lyophilized powder, for preparing intravenous iv infusions, in pharmacy bulk package bottles containing the equivalent of 5 grams or 10 grams vancomycin base. Howevday, iv after 1,000 virtual concentrations were obtained, for each dose scheme, the areas under the curve auc were. Please use this information in conjunction with the patient selfadministration iv. Proposed version of the microbiology subsection of the package insert.
Targocid art 30 chmp opinion european medicines agency. This reference contains standard dilutions including iv admixture drug concentration, infusion volumes, and infusion rates. What teicoplanin is and what it is used for teicoplanin is an antibiotic, it contains a medicine called teicoplanin. Jul 01, 2011 the standard dosing regimen 400 mg every 12 hr for 3 doses, then 400 mg once a day, iv recommended by the summary in the package insert of teicoplanin for severe infections has a tar of about 70% under steadystate ss conditions when c trough 10 mgl and auc 24 mic 125 were used as the therapeutic targets of teicoplanin.
Daptomycin versus teicoplanin for bloodstream infection. Dyna teicoplanin 400 mg is a whiteyellow lyophilised freezedried powder. One resource multiple technologies thermo fisher scientific. Teicoplanin usual diluents stable in ns, lr, d 5 w reconstitution avoid foaming of solution by slowly adding entire contents of water ampul for reconstitution and gently rolling the vial until powder is completely dissolved. To minimize excessive foaming, gently dissolve the mycamine powder by swirling the vial. Dyna teicoplanin solvent is a clear, colourless, odourless liquid. Adverse events related to teicoplanin occurred in 7. Annex iii summary of product characteristics, labelling and. Administration of parenteral antibiotics to outpatients is increasingly used to reduce hospital costs, to reduce loss of earnings for the patient and to improve the quality of life in patients requiring prolonged antibiotic treatment. This smpc, labelling and packages leaflet is the version valid at the time of commission decision. It works by killing the bacteria that cause infections in your body.
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