Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Sucrose
L-histidine monohydrochloride monohydrate
L-histidine
L-methionine
Polysorbate 80
EDTA disodium salt dihydrate
Water for injection
6.2    Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. STELARA should only be diluted with sodium chloride 9 mg/mL (0.9%) solution.
STELARA should not be administered concomitantly in the same intravenous line with other medicinal products.

6.3    Shelf life

The expiry date of the product is indicated on the packaging materials.
Do not freeze.
Chemical and physical in-use stability has been demonstrated for 8 hours at 15-25°C.

From a microbiological point of view, unless the method of dilution 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 user.

6.4    Special precautions for storage

Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the vial in the outer carton in order to protect from light.
For storage conditions after dilution of the medicinal product, see section 6.3 
6.5    Nature and contents of container

26 mL solution in a type I glass 30 mL vial closed with a coated butyl rubber stopper. STELARA is available in a 1 vial pack.
6.6    Special precautions for disposal and other handling

The solution in the STELARA vial should not be shaken. The solution should be visually inspected for particulate matter or discolouration prior to administration. The solution is clear, colourless to light yellow. The medicinal product should not be used if the solution is discoloured or cloudy, or if foreign particulate matter is present.

Dilution
STELARA concentrate for solution for infusion must be diluted and prepared by a healthcare professional using aseptic technique.



1.     Calculate the dose and the number of STELARA vials needed based on patient weight (see section 4.2, Table 1). Each 26 mL vial of STELARA contains 130 mg of ustekinumab. Only use complete vials of STELARA.
2.     Withdraw and discard a volume of the sodium chloride 9 mg/mL (0.9%) solution from the
250 mL infusion bag equal to the volume of STELARA to be added. (discard 26 mL sodium chloride for each vial of STELARA needed, for 2 vials-discard 52 mL, for 3 vials- discard 78 mL, for 4 vials- discard 104 mL)
3.     Withdraw 26 mL of STELARA from each vial needed and add it to the 250 mL infusion bag.
The final volume in the infusion bag should be 250 mL. Gently mix.
4.     Visually inspect the diluted solution before administration. Do not use if visibly opaque particles, discolouration or foreign particles are observed.
5.     Administer the diluted solution over a period of at least one hour. Once diluted, the infusion should be completed within eight hours of the dilution in the infusion bag.
6.     Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 0.2 micrometer).
7.     Each vial is for single use only and any unused medicinal product should be disposed of in accordance with local requirements.