Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
 glycine mannitol sodium chloride

Other components:
Thymoglobuline may also contain residues of polysorbate, from the manufacturing process.

6.2 Incompatibilities

Based on a single compatibility study (Trissel LA,. 2003; Am J Health Syst Pharm) the combination of Thymoglobuline, heparin and hydrocortisone in a dextrose infusion solution has been noted to precipitate and is not recommended.

In the absence of additional pharmaceutical incompatibility data, Thymoglobuline must not be mixed with other medicinal products in the same infusion.

6.3 Shelf life

The expiry date of the product is indicated on the packaging materials Immediate use after dilution is recommended in order to prevent microbial contamination.

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 2-8ºC, unless reconstitution or dilution has taken place in controlled and validated aseptic conditions.



6.4 Special precautions for storage

Store refrigerated (at 2ºC - 8ºC).
Do not freeze.
For storage conditions of the reconstituted and diluted medicinal product, see section 6.3 
6.5 Nature and contents of container

Powder in a vial (type I glass) closed with a stopper Each pack contains one 10 ml vial.
6.6 Special precautions for disposal and other handling

Reconstitute the powder with 5 ml of sterile water for injections to obtain a solution containing 5 mg of protein per ml.
The solution is clear or slightly opalescent. Reconstituted medicinal product should be inspected visually for particulate matter and discoloration. Should some particulate matter remain, continue to gently rotate the vial until no particulate matter is visible. If particulate matter persists, discard the vial. Immediate use of reconstituted product is recommended. Each vial is for single use only. Depending on the daily dose, reconstitution of several vials of Thymoglobuline powder might be needed. Determine the number of vials to be used and round up to the nearest vial. To avoid inadvertent administration of particulate matter from reconstitution, it is recommended that Thymoglobuline is administered through a 0.22 µm in- line filter.
The daily dose is diluted in an infusion solution (0.9% sodium chloride or 5% glucose solution) so as to obtain a total infusion volume of 50 to
500 ml (usually 50 ml/vial).
The medicinal product should be administered on the same day.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.