Edicin

Edicin Caution For Usage

vancomycin

Manufacturer:

Sandoz

Distributor:

Zuellig Pharma
Full Prescribing Info
Caution For Usage
Incompatibilities: Vancomycin solutions have a low pH value. This may lead to chemical or physical instability if mixed with other substances. Therefore, each parenteral solution should be checked visually for precipitations and discolouration prior to use.
This medicinal product must not be mixed with other medicinal products except those mentioned in Instructions for use and handling as follows.
Combination therapy: In case of combination therapy of vancomycin with other antibiotics/chemotherapeutics, the preparations should be administered separately.
Mixtures of solutions of vancomycin and beta-lactam antibiotics have been shown to be physically incompatible. The likelihood of precipitation increases with higher concentrations of vancomycin. It is recommended to adequately flush the intravenous lines between administration of these antibiotics. It is also recommended to dilute solutions of vancomycin to 5 mg/mL or less.
Instructions for use and handling: The product must be reconstituted and the resulting concentrate must then be diluted prior to use.
Preparation of the reconstituted solution: Dissolve Vancomycin 500 mg Powder for solution for infusion in 10 ml of sterile Water for injection.
One ml of reconstituted solution contains 50 mg of vancomycin.
Appearance of reconstituted solution: After reconstitution the solution is clear and colorless to slightly yellowish brown without visible particles.
For storage conditions of the reconstituted medicinal product, see Shelf-life under Storage.
Preparation of final diluted Solution for infusion: Reconstituted solutions containing 50 mg/ml of vancomycin should be further diluted.
Suitable diluents are: 5% Glucose Injection or 0.9% Sodium Chloride Injection or 5% Glucose Injection with 0.9% Sodium Chloride Injection.
Intermittent infusion: Reconstituted solution containing 500 mg of vancomycin (50 mg/ml) must be diluted further with at least 100 ml diluent (to 5 mg/ml).
The concentration of vancomycin in Solution for infusion should not exceed 5 mg/ml.
The desired dose should be administered slowly by intravenous use at a rate of no more than 10 mg/minute, for at least 60 minutes or even longer.
Continuous infusion: This should be used only if treatment with an intermittent infusion is not possible. Dilute 1000 mg to 2000 mg of dissolved vancomycin in a sufficient amount of the previously mentioned suitable diluent and administer it in the form of a drip infusion, so that the patient will receive the prescribed daily dose in 24 hours.
Appearance of diluted solution: After dilution the solution is clear and colorless without visible particles.
For storage conditions of the diluted medicinal product, see Shelf-life under Storage.
Before administration, the reconstituted and diluted solutions should be inspected visually for particulate matter and discoloration. Only clear, and colorless solution free from particles should be used.
Disposal: Vials are for single use only. Unused medicinal products must be discarded.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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