Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients

Citric acid, anhydrous and mannitol.

6.2 Incompatibilities

Dacarbazine solution is chemically incompatible with heparin, hydrocortisone, L-cysteine, and sodium hydrogen carbonate.


6.3 Shelf life
The expiry date of the product is indicated on the packaging materials.

Shelf life of the reconstituted solution of Dacarbazine medac 500mg / 1000 mg: Chemical and physical in-use stability has been demonstrated for 48 hours at 2-8 °C protected from light.
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 be no longer than 24 hours at 2 – 8 °C, unless reconstitution has taken place in controlled and validated aseptic conditions.

Shelf life of the reconstituted and further diluted solution of Dacarbazine medac 500 mg / 1000 mg: 
Chemical and physical in-use stability has been demonstrated for 2 hours at 25°C for the reconstituted and further diluted solution in polyethylene containers and for 24 hours at 2 - 8 °C protected from light in polyethylene containers as well as in glass bottles.
From a microbiological point of view, the reconstituted and further diluted solution must be used immediately.


6.4 Special precautions for storage
Do not store above 25 °C.
Keep the vial in the outer carton in order to protect from light. Reconstituted solutions should also be protected from light.
Keep out of reach of children
For storage conditions after reconstitution of the medicinal product, see section 6.3.


6.5 Nature and contents of container
Dacarbazine medac 500 mg / 1000 mg is supplied as a sterile powder for solution for infusion in single-dose vials made of amber glass (Type I, Ph.Eur.) and closed with butyl rubber stoppers. Each carton of Dacarbazine medac 500 mg / 1000 mg) contains 1 vial or 10 vials.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Recommendations for safe handling

Dacarbazine is an antineoplastic agent and should be handled according to standard procedures for cytostatics that have mutagenic, carcinogenic and teratogenic effects. Before commencing, local cytotoxic guidelines should be referred to.

Dacarbazine should only be opened by trained staff and as with all cytotoxic agents; precautions should be taken to avoid exposing staff. Handling of cytotoxic medicinal products should be generally avoided during pregnancy. Preparation of solution for administration should be carried out in a designated handling area and working over a washable tray or disposable plastic-backed absorbent paper.

Suitable eye protection, disposable gloves, face mask and disposable apron should be worn. Syringes and infusion sets should be assembled carefully to avoid leakage (use of Luer lock fittings is recommended).

On completion, any exposed surface should be thoroughly cleaned and hands and face washed.

In the event of spillage, operators should put on gloves, face masks, eye-protection and disposable apron and mop up the spilled material with an absorbent material tapped in the area for that purpose. The area should then be cleaned and all contaminated material transferred to a cytotoxic spillage bag or bin or sealed for incineration.

Preparation for intravenous administration
Dacarbazine-solutions are prepared immediately before use.

Dacarbazine is sensitive to light exposure. During administration, the infusion container and administration set should be protected from exposure to daylight, e.g., by using light-resistant PVC-infusion sets. Normal infusion sets should be wrapped up in e.g., UV-resistant foils.

 b) Preparation of Dacarbazine medac 500 mg:
Aseptically transfer 50 ml water for injections into the vial and shake until a solution is obtained. The resulting solution, containing 10 mg/ml of dacarbazine (density of solution: ρ = 1.007 g/ml) has to be further diluted with 200 - 300 ml 0.9 % sodium chloride or 5 % glucose solution for infusion. The obtained solution for infusion, containing 1.4 – 2.0 mg/ml of dacarbazine, is ready for i. v. infusion and should be given over a period between 20 - 30 minutes.
 c) Preparation of Dacarbazine medac 1000 mg:

Aseptically transfer 50 ml water for injections into the vial and shake until a solution is obtained. The resulting solution, containing 20 mg/ml of dacarbazine (density of solution: ρ = 1.015 g/ml) has to be further diluted with 200 – 300 ml 0.9 % sodium chloride or 5 % glucose solution for infusion. The obtained solution for infusion, containing 2.8 – 4.0 mg/ml of dacarbazine, is ready for i. v. infusion and should be given over a period between 20 – 30 minutes.

Dacarbazine medac 500 mg / 1000 mg is for single use only.
The diluted solution for infusion should be visually inspected and only clear solutions practically free from particles should be used. Do not use the solution if particles are present.
Any solutions where the visual appearance has changed should be discarded.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


7. MANUFACTURER medac
Gesellschaft für klinische Spezialpräparate mbH,
Wedel, Germany

8. REGISTRATION NUMBER
Dacarbazine medac 500 mg: 134-89-31171
Dacarbazine medac 1000 mg: 134-90-31172