Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients
Sodium phosphate monobasic, monohydrate
Polysorbate 20
Sodium chloride
Sodium hydroxide
Water for injections

6.2   Incompatibilities
In the absence of compatibility studies this medicinal product must not be mixed with other medicinal products.

6.3   Shelf life
The expiry date of the product is indicated on the packaging materials.
Chemical and physical in use stability has been demonstrated for 24 hours at 25°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 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

6.4   Special precautions for storage
Store in a refrigerator (2°C – 8°C).

6.5    Nature and contents of container
3.5 ml of concentrate for solution for infusion in a 5 ml vial (Type I glass) with a stopper (fluoro-resin coated butyl rubber), a one piece seal (aluminium) and flip-off cap.
Pack size of 1vial.

6.6    Special precautions for disposal and other handling

• Calculate the dose and number of Replagal vials needed.
• Any dose change should occur only at the direction of the treating physician.

• Dilute the total volume of Replagal concentrate required in 100 ml of 9 mg/ml (0.9%) sodium chloride solution for infusion. Care must be taken to ensure the sterility of the prepared solutions since Replagal does not contain any preservative or bacteriostatic agent; aseptic technique must be observed. Once diluted, the solution should be mixed gently but not shaken.

Since no preservative is present, it is recommended that administration is started as soon as possible after dilution (see section 6.3).

• The solution should be inspected visually for particulate matter and discolouration prior to administration.
• For single use only. Any unused product or waste material should be disposed of in accordance with local requirements.