Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sulfuric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)
Water for injections
6.2 Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
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.

Shelf life after first opening:
The medicinal product should be used immediately after opening the ampoule (see section 6.6).
Shelf life after dilution:
Chemical and physical in-use stability has been demonstrated for 72 hours at 30°C and 2 – 8°C when diluted to a concentration of not more than 200 mg/mL magnesium sulfate heptahydrate in 0.9% Sodium chloride or 5% Glucose solution.

Solutions diluted to 25% should be used immediately.

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 dilution has taken place in controlled and validated aseptic conditions.
6.4 Special precautions for storage
Store below 30oC , do not freeze
For storage conditions after dilution or first opening of the medicinal product, see section 6.3.

6.5 Nature and contents of container
2 ml or 10 ml of solution in type I hydrolytic class colourless borosilicate glass ampoules with one point cut.
Ampoules are packed in liner. Liners are packed into outer carton.

Pack size:
10 ampoules
Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling
For intramuscular use, a 50% solution is used undiluted or diluted to 25%. For intravenous use, the 50% solution must be diluted before use., with a suitable diluent, such as 5% Glucose or 0.9%sodium chloride solution.
For single use only. Discard any unused contents.
This medicinal product should be used immediately after opening the ampoule (section 6.3).
This medicine should not be used if there are any visible signs of deterioration (e.g. particles).
Instruction of ampoule opening:
1) Turn the ampoule with coloured point up. If there is any solution in the upper part of the ampoule, gently tap with your finger to get all the solution to the lower part of the ampoule.
2) Use both hands to open; while holding the lower part of the ampoule in one hand, use the other hand to break off the upper part of the ampoule in the direction away from the coloured point (see the pictures below).



Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7.Marketing Authorization Holder and Importer:
A.L.Medi-Market Ltd., 3 Hakatif street, Emek Hefer Industrial Park, 3877701