Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Sodium hydroxide

Hydrochloric acid (for pH adjustment)

Water for injections
6.2 Incompatibilities

In the absence of incompatibility studies, this medicinal product must not be mixed with other medicinal  products except those mentioned in section 6.6.

6.3 Shelf life
Unopened vial
3 years
After first opening
The product should be used immediately.
The expiry date of the product is indicated on the packaging materials.

After dilution

Chemical and physical in use stability has been demonstrated for 24 hours at 15-25°C and 
48 hours at 2-8 °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 2-8 °C, unless dilution has taken place in controlled and validated aseptic conditions.

ARSENIC TRIOXIDE S.K. 1MG/ML vial is single-dose and does not contain any preservatives.

6.4 Special precautions for storage
Do not store above 300C. Do not freeze.

For storage conditions after dilution of the medicinal products, see section 6.3.

6.5 Nature and contents of container
ARSENIC TRIOXIDE S.K. 1MG/ML concentrate for solution for infusion. 10 ml concentrate in a clear, Type I glass vial with a bromobutyl rubber stopper grey (FluroTec coated) and sealed with an aluminium flip-off cap with polypropylene disk.

Each pack contains 10 vials.

6.6 Special precautions for disposal and other handling
Preparation of ARSENIC TRIOXIDE S.K. 1MG/ML

Aseptic technique must be strictly observed throughout handling of ARSENIC TRIOXIDE S.K. 1MG/ML since no preservative is present.

ARSENIC TRIOXIDE S.K. 1MG/ML must be diluted with 100 to 250 ml of glucose 50 mg/ml (5%) solution for injection or sodium chloride 9 mg/ml (0.9 %) solution for injection immediately after withdrawal from the vial.

ARSENIC TRIOXIDE S.K. 1MG/ML must not be mixed with or concomitantly administered in the same intravenous line with other medicinal products.

The diluted solution must be clear and colourless. All parenteral solutions must be inspected visually for  particulate matter and discoloration prior to administration. Do not use the preparation if foreign  particulate matter is present.

Procedure for proper disposal
ARSENIC TRIOXIDE S.K. 1MG/ML is for single use only and any unused portions of each vial must be discarded properly. Do not save any unused portions for later administration.

Any unused medicinal product, any items that come into contact with the product or waste material  must be disposed of in accordance with local requirements.
7. LICENCE HOLDER AND MANUFACTURER

Licence holder:
K.S.Kim International (SK-PHARMA) Ltd

94 YIGAL ALON STR., TEL-AVIV-YAFO, 6789139

Israel
Manufacturer:

Haupt Pharma Wolfratshausen GmbH
Pfaffenrieder Strasse 5, 82515 Wolfratshausen,

Germany