Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients

Sucrose
Sodium chloride
Sodium phosphate dibasic
Sodium phosphate monobasic
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
6.2   Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
Reconstituted solution
Chemical and physical in-use stability has been demonstrated for 24 hours below 25°C. From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Diluted solution
Chemical and physical in-use stability has been demonstrated for 48 hours at 2°C-8°C. From a microbiological point of view, the product should be used immediately. 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°C-8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.

6.4   Special precautions for storage

Store in a refrigerator (2°C–8°C).
Do not freeze.
For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.

6.5   Nature and contents of container

Type I clear glass vial with chlorobutyl elastomer stopper, sealed with an aluminium seal with polypropylene flip-off cap, containing 3,750 U pegaspargase.

Pack size of 1.

6.6   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 section 4.2).

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.
The diluted solution can be given over 1 to 2 hours together with an already-running infusion of sodium chloride 9 mg/ml. Do not infuse other medicinal products through the same intravenous line during administration of Oncaspar (see section 4.2).
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 section 6.3).

Disposal
Oncaspar is for single use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.