Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Dehydrated alcohol
Polyoxyethylene hydrogenated castor oil
6.2   Incompatibilities

When diluting, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Tacrolimus is absorbed by PVC plastics. Tubing, syringes and any other equipment used to prepare and administer Prograf 5 mg/ml concentrate for solution for infusion should not contain PVC.
Tacrolimus is unstable under alkaline conditions. Combination of the reconstituted Prograf 5 mg/ml concentrate for solution for infusion with other pharmaceutical products that produce a marked alkaline solution (e.g., aciclovir and ganciclovir) should be avoided.

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 the dilution has taken place in controlled and validated aseptic conditions.

6.4   Special precautions for storage

Store ampoule in the original package in order to protect from light.
Do not store above 25°C.
For storage conditions after dilution of the medicinal product, see section 6.3.
6.5   Nature and contents of container

1 ml concentrate for solution for infusion in 2 ml, type I Ph. Eur. clear colourless glass ampoules.
Each carton contains 10 ampoules.

6.6   Special precautions for disposal and other handling
Based on immunosuppressive effects of tacrolimus, inhalation or direct contact with skin or mucous membranes by the formulations for injection, powder or granule contained in tacrolimus products should be avoided during preparation. If such contact occurs, wash the skin and flush the affected eye or eyes.
Prograf 5 mg/ml concentrate for solution for infusion must not be injected undiluted.
Prograf 5 mg/ml concentrate for solution for infusion should be diluted in 5% w/v glucose solution or physiological saline solution in polyethylene, polypropylene or glass bottles, but not in PVC containers (see section 6.2). Only transparent and colourless solutions should be used.
The concentration of a solution for infusion should be within the range 0.004 - 0.100 mg/ml. The total volume of infusion during a 24-hour period should be in the range 20 - 500 ml.
The diluted solution should not be given as a bolus.
Any unused concentrate in an opened ampoule or unused reconstituted solution should be disposed of immediately in accordance with local requirements to avoid contamination.


7.   LICENSE HOLDER AND MANUFACTURER
License Holder
Astellas Pharma International B.V.
21 Ha’melacha Street, Rosh Ha’ayin, 4809157, Israel