TEICOPLANIN ALTAN

Posology The dose and duration of treatment should be adjusted according to the underlying type and severity of infection and clinical response of the patient, and patient factors such as age and renal function. Measurement of serum concentrations 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: • For most Gram-positive infections, teicoplanin trough levels of at least 10 mg/L when measured by High Performance Liquid Chromatography (HPLC), or at least 15 mg/L when measured by Fluorescence Polarization Immunoassay (FPIA) method.

• For endocarditis and other severe infections, teicoplanin trough levels of 15-30 mg/L when measured by HPLC, or 30-40 mg/L when measured by FPIA method. During maintenance treatment, teicoplanin trough serum concentrations monitoring may be performed at least once a week to ensure that these concentrations are stable.

Adults and elderly patients with normal renal function Loading dose Maintenance doseIndications Loading dose regimen Targeted through concentrations at day 3 to 5 Maintenance dose Targeted through concentrations during maintenance - Complicated 6 mg/kg body > 15 mg/L1 6 mg/kg body > 15 mg/L1 skin and soft tissue infections - Pneumonia - Complicated urinary tract infections weight every 12 hours for 3 administrations weight intravenous or intramuscular once a day once a week - Bone and joint infections 12 mg/kg body weight every 12 hours for 3 to 5 administrations > 20 mg/L1 12 mg/kg body weight intravenous or intramuscular once a day > 20 mg/L1 - Infective endocarditis 12 mg/kg body weight every 12 hours for 3 to 5 administrations 30-40 mg/L1 12 mg/kg body weight intravenous or intramuscular once a day > 30 mg/L1 1 Measured by FPIA The dose is to be adjusted on bodyweight whatever the weight of the patient.

Duration of treatment The duration of treatment should be decided based on the clinical response. For infective endocarditis a minimum of 21 days is usually considered appropriate. Treatment should not exceed 4 months. Combination therapy Teicoplanin has a limited spectrum of antibacterial activity (Gram positive).

It is not suitable for use as a single agent for the treatment of some types of infections unless the pathogen is already documented and known to be susceptible or there is a high suspicion that the most likely pathogen(s) would be suitable for treatment with teicoplanin.

Tabulated list of adverse reactions In the table below all the adverse reactions, which occurred at an incidence greater than placebo and more than one patient are listed using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. g. 4) Renal and Urinary disorders Blood creatinine increased Renal failure (including renal failure acute) (see below description of selected adverse reactions)* General disorders and administratio n site conditions Pain, pyrexia Injection site abscess, chills (rigors) Investigation s Transaminases increased (transient abnormality of transaminases), blood alkaline phosphatase increased (transient abnormality of alkaline phosphatase) Description of selected adverse reactions *Based on literature reports, the estimated rate of nephrotoxicity in patients receiving low loading dose regimen of average 6 mg/kg twice a day, followed by a maintenance dose of average 6 mg/kg once daily, is around 2%.

5%]) over the first 10 days. 8%]). 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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Teicoplanin should not be administered by intraventricular use. g. anaphylactic shock). If an allergic reaction to teicoplanin occurs, treatment should be discontinued immediately and appropriate emergency measures should be initiated.

Teicoplanin must be administered with caution in patients with known hypersensitivity to vancomycin, as crossed hypersensitivity reactions, including fatal anaphylactic shock, may occur. However, a prior history of "red man syndrome" with vancomycin is not a contraindication to the use of teicoplanin.

Infusion related reactions 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. Stopping or slowing the infusion may result in cessation of these reactions.

Infusion related reactions can be limited if the daily dose is not given via bolus injection but infused over a 30-minute period. Severe bullous reactions Life-threatening or even fatal cutaneous reactions Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) have been reported with the use of teicoplanin.

g. progressive skin rash often with blisters or mucosal lesions) are present teicoplanin treatment should be discontinued immediately. Spectrum of antibacterial activity Teicoplanin has a limited spectrum of antibacterial activity (Gram-positive).

It is not suitable for use as a single agent for the treatment of some types of infections unless the pathogen is already documented and known to be susceptible or there is a high suspicion that the most likely pathogen(s) would be suitable for treatment with teicoplanin.

The rational use of teicoplanin should take into account the bacterial spectrum of activity, the safety profile and the suitability of standard antibacterial therapy to treat the individual patient. On this basis it is expected that in most instances teicoplanin will be used to treat severe infections in patients for whom standard antibacterial activity is considered to be unsuitable.

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