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Special precautions for disposal and other handling: This medicinal product can cause irritation on contact. The powder must therefore be handled and administered with particular caution. Inhalation of the vapour and contact with the skin and mucous membranes, especially the eyes, must be avoided; if the medicinal product comes in contact with eyes, skin or mucous membranes, rinse immediately with plenty of water for at least 15 minutes.
Oncaspar is to be administered intravenously or intramuscularly after reconstitution of the product. The powder must be reconstituted with 5.2 ml water for injections prior to administration (see Dosage & Administration).
Instructions for handling:
1. Staff should be trained in how to handle and transfer the medicinal product (pregnant staff should be excluded from working with this medicinal product).
2. Aseptic technique must be used.
3. Procedures for proper handling of antineoplastic agents should be observed.
4. The use of disposable gloves and protective garments is recommended when handling Oncaspar.
5. All items for administration or cleaning, including gloves, should be placed in high-risk waste disposal bags for high-temperature incineration.
Reconstitution:
1. 5.2 ml water for injections are injected into the vial using a syringe and 21 gauge needle.
2. The vial should be gently swirled until the powder is reconstituted.
3. After reconstitution, the solution should be clear, colourless and free from visible foreign particles. Do not use if the reconstituted solution is cloudy or if a precipitate has formed. Do not shake.
4. The solution should be used within 24 hours after reconstitution, when stored below 25°C.
Administration:
1. Parenteral medicinal products should be inspected for particulate matter prior to administration, only a clear, colourless solution free from visible foreign particles should be used.
2. The medicinal product should be administered intravenously or intramuscularly. The solution should be administered slowly.
For intramuscular injection, the volume should not exceed 2 ml in children and adolescents and 3 ml in adults.
For intravenous administration, the reconstituted solution should be diluted in 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection or 5% glucose solution.
The diluted solution can be given over 1 to 2 hours together with an already-running infusion of either sodium chloride 9 mg/ml or 5% glucose. Do not infuse other medicinal products through the same intravenous line during administration of Oncaspar (see Dosage & Administration).
After dilution, the solution should be used immediately. If immediate use is not possible, the diluted solution can be stored at 2°C-8°C for up to 48 hours (see Shelf life under Storage).
Disposal: Oncaspar is for single use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Incompatibilities: This medicinal product must not be mixed with other medicinal products except those previously mentioned in Special precautions for disposal and other handling.
