Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Sodium chloride
Water for injections
Hydrochloric acid (for pH adjustment and conversion of midazolam to the hydrochloride salt) Sodium hydroxide (for pH adjustment)

6.2 Incompatibilities

Not applicable
6.3 Shelf life

The expiry date is indicated on the packaging materials

6.4 Special precautions for storage

Store below 25°C.
Keep the oral syringe in the protective plastic tube.
Do not refrigerate or freeze.

6.5 Nature and contents of container
Amber, pre-filled needle-free oral syringe (polypropylene) with plunger (polypropylene) and end cap (high density polyethylene) packed in a protective, capped plastic tube.
Strength              Volume of solution Syringe volume            Age range             Label colour 2.5 mg                0.5 ml                  1 ml                 3 months to < 1       Yellow year
5 mg                  1 ml                    3 ml                 1 year to < 5 years   Blue 7.5 mg                1.5 ml                  3 ml                 5 years to < 10       Purple years
10 mg                 2 ml                    3 ml                 10 years to < 18      Orange years

BUCCOLAM is available in two pack sizes:
- cartons containing 2 pre-filled syringes
- cartons containing 4 pre-filled syringes
Not all pack sizes may be marketed.

6.6 Special precautions for disposal
Administration of BUCCOLAM
BUCCOLAM is not for intravenous use.

Step 1

Hold the plastic tube and pull the cap off.
Take the syringe out of the tube.


Step 2

Pull the red cap off the tip of the syringe and dispose of it safely.



Step 3
Using the finger and thumb gently pinch and pull back the child’s cheek. Put the tip of the syringe into the back of the space between the inside of the cheek and the lower gum.



Step 4

Slowly press the syringe plunger until the plunger stops.
The full amount of solution should be inserted slowly into the space between the gum and the cheek (buccal cavity).

If necessary (for larger volumes and/or smaller patients), approximately half the dose should be given slowly into one side of the mouth, then the other half given slowly into the other side.

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