Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1    List of excipients
Sodium chloride, Chlorbutanol hemihydrate, HCl, Purified water.

6.2    Incompatibilities
Not applicable

6.3    Shelf Life
The expiry date of each product is indicated on the packaging materials.
After first opening Minirin solution can be stored 2 months.
6.4    Storage Conditions
Store in a refrigerator at a temperature of 20C to 80C.
6.5    Nature and contents of container
Amber, Type I (Ph.Eur.) glass vial fitted with a dropper closure and containing 2.5ml (nominal volume) of a clear aqueous solution accompanied with a calibrated plastic tube (rhinyle) for administration. The rhinyle tube has 5 dosing marks: 0.025 ml, 0.050 ml, 0.100 ml, 0.150 ml and 0.200 ml.
6.6    Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product Instructions for use of DDAVP/Desmopressin Nasal drops, solution:

1.   Pull plastic tag on neck of bottle.

2.   Break security seal and remove plastic cap.
3.   Twist off the small knurled seal from the dropper. Use the same seal reversed to prevent subsequent leakage, especially if the bottle is not stored upright.

4.   Take the calibrated part of the plastic tube (rhinyle) in one hand and place the fingers of the other hand around the cylindrical part of the dropper. Insert the top of the dropper in a downward position into the end of the rhinyle marked with an arrow and squeeze the dropper until the solution has reached the desired mark. If difficulty is experienced in filling the rhinyle, a diabetic or tuberculin syringe may be used to draw up the dose and load the rhinyle.

5.   Hold the rhinyle with the fingers approximately ¾ inch from the end and insert it into the nostril until the tips of the fingers reach the nostril.

6.   Put the other end of the rhinyle into the mouth. Hold the breath, tilt back the head and then blow with a short strong puff through the rhinyle so that the solution reaches the right place in the nasal cavity. Through this procedure, medication is limited to the nasal cavity and the preparation does not pass down into the back of the throat.

7.   If this product is for a child, the dose should be given or supervised by an adult.

8.   After use, close the bottle with the plastic cap, wash the rhinyle in water and shake thoroughly, until no more water is left. The rhinyle can then be used for the next application.