Pharmaceutical particulars : מידע רוקחי

6.      PHARMACEUTICAL PARTICULARS
6.1     List of excipients

None.

6.2 Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.


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

Reconstituted solution:
The reconstituted solution has to be diluted for solution for infusion immediately 

Ready –for-use-solution:
Chemical and physical in-use stability of the solution for infusion has been demonstrated for 16 hours at 25°C protected from light (using light protection Perfusor syringe). From a microbiological point of view, the solution for infusion 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 to 8 °C, unless reconstitution / dilution has taken place in controlled and validated conditions.


6.4 Special precautions for storage
Store below 30°C. Keep out of the sight and reach of children.
Keep the ampoules in the outer carton in order to protect from light.
Protect the solution for infusion from light by using coloured syringes and tubes.

6.5   Nature and contents of the container
 packs containing 5 ampoules with lyophilized powder for solution for infusion.

6.6   Special precautions for disposal and other handling

Preparation of the solution for infusion
The powder for solution for infusion (the content of the brown ampoule is equivalent to 60 mg of sodium nitroprusside dihydrate) is dissolved in water for injections or in a 5% glucose solution. This concentrated solution has a reddish- brownish colour and must never be injected directly. Only 5% glucose solution may be used for the further dilution. The solution for infusion containing the sodium nitroprusside must be prepared immediately prior to the administration.


In order to avoid injection of particles of more than 5 µm in size, it is recommended to filter the reconstituted solution using a filter with a maximum pore size of 5 micrometres or alternatively to filter the solution for infusion with an inline filter with a maximum pore size of 5 micrometres prior to use.


The ampoule is already serrated below the white dot. It is thus not necessary to saw the ampoule. Break open the ampoule as usual.


Perfusor® (see also dosing table in section 4.2)
When using a Perfusor, 50 mL of a 5% glucose solution are first drawn into a 50 mL Perfusor syringe. The Nipruss ampoule is opened and filled up to around three quarters of the volume with glucose solution from the Perfusor syringe.
Once the powder is dissolved, the thus concentrated solution is drawn into the 

Perfusor syringe. To prevent overdoses, the content of the syringe must be homogeneously mixed by shaking.


Infusomat®
When using an Infusomat, the content of one ampoule, after dissolution in water for injections or in 5% glucose solution, is injected into 250 or 500 mL of a 5% glucose solution. For controlled intraoperative hypotension, dilution in 250 mL is recommended. The conversion of the dosing is detailed in the dosage table. The infusion rates indicated in the dosage table in mL per hour are multiplied by a factor of 5 when diluting in 250 mL of glucose, and with a factor of 10 when diluting in 500 mL. To prevent a high fluid load, the Perfusor is the preferred method for prolonged infusions.