Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Water for injections
Sulfuric acid (for pH adjustment)

6.2 Incompatibilities
This medicinal product must not be mixed with other medicinal products/diluents except Glucose 5% or sodium chloride 0.9%.

Magnesium sulfate is incompatible with alkali hydroxides (forming insoluble magnesium hydroxide), alkali carbonates (forming insoluble magnesium carbonate) and salicylates. The activities of streptomycin sulfate and tetramycin sulfate are inhibited by magnesium ions.

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

After opening/dilution:
Chemical and physical in-use stability has been demonstrated for 48 hours at 23 – 27°C and 2 – 8°C when diluted to a concentration of not more than 200 mg/mL magnesium sulfate heptahydrate in Sodium chloride 0.9% or Glucose 5%. 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 responsibilities of the user and would normally not be longer than 24 hours at 2 – 8°C unless reconstitution/dilution (etc.) has taken place in controlled and validated aseptic conditions.

6.4 Special precautions for storage
Do not store above 25oC .

6.5 Nature and contents of container
Polypropylene ampoules of 10 mL containing a 50 % w/v solution of magnesium sulfate as heptahydrate for injection. Packed in cartons to contain 10, 20 or 50 ampoules.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling
For intramuscular use, a 50% w/v solution is used. For intravenous use, the 50% w/v solution must be diluted before use, with a suitable diluent, such as Glucose 5% or sodium chloride 0.9%.

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

7.MARKETING AUTHORIZATION HOLDER AND IMPORTER
Inovamed Ltd. 55 Beer Ganim St. POB 62 Even Yehuda 40500