Pharmaceutical particulars : מידע רוקחי

 6.      PHARMACEUTICAL PARTICULARS

6.1     List of excipients

Lactose monohydrate
Asparagine monohydrate
Citric acid monohydrate
Potassium phosphate (dibasic)
Magnesium sulfate heptahydrate
Iron ammonium citrate
Glycerin
Zinc formate
Ammonium hydroxide
6.2     Incompatibilities

OncoTICE is incompatible with hypo and hypertonic solutions. OncoTICE should only be mixed with physiological saline as described in section 6.6. Other incompatibility studies have not been performed.

6.3     Shelf life

The expiry date of the product is indicated on the packaging materials. In-use stability of the reconstituted product has been demonstrated for 2 hours at 2-8°C protected from light. From a microbiological point of view, unless the method of opening/reconstitution/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 the user.

6.4     Special precautions for storage

Store at 2-8ºC, protect from light.
6.5     Nature and contents of containers

2 ml Type 1 glass vials in packs of 1 and 3.
Not all pack sizes may be marketed.

6.6     Special precautions for disposal and other handling
OncoTICE contains live, attenuated mycobacteria. Because of the potential risk for transmission, it should be prepared, handled and disposed of as a biohazard material (see section 4.4).

Perform the following procedures under aseptic conditions using sterile physiological saline solution as the diluent and suitable techniques to ensure protection of the health care worker.
The use of closed-system transfer device products may be considered when transferring OncoTICE from primary packaging to instillation equipment.

Reconstitution
Transfer 50ml of the diluent into a sterile container and add 1ml from the sterile container to the vial. Ensure that the needle is inserted through the center of the rubber stopper. Allow to stand for a few minutes then gently swirl until a homogenous suspension is obtained. Forceful agitation should be avoided.

Preparation of the solution for instillation
Transfer the reconstituted contents of the vial back into the container. Rinse the vial by transferring 1ml from the container back into the vial, then add back to the container. If a closed-system transfer device is not available, dilute the reconstituted 1ml suspension in sterile physiological saline up to a volume of 49ml. Then rinse the empty vial with 1ml of sterile physiological saline. Add the rinse fluid to the reconstituted suspension for a final volume of 50ml.
Mix the suspension carefully.
The suspension, with a total volume of 50ml is now ready for instillation; it contains a total of 2- 8 x 108 CFU of Tice BCG.


7.    MARKETING AUTHORIZATION HOLDER AND IMPORTER
Merck Sharp & Dohme (Israel-1996) Company Ltd, 34 Ha’charash St., Hod-Hasharon.