Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Inert gases
6.2. Incompatibilities
Carbon dioxide should not be given when adrenaline is used.
6.3. Shelf life
The expiry date of the product is indicated on the packaging materials 6.4 Special precautions for storage


Store below 52 º C in a well ventilated place
Carbon Dioxide cylinders should be:
• stored under cover, preferably inside, kept dry and clean, and not subjected to extremes of heat or cold and away from stocks of combustible material.
• stored separately from industrial and other non-medical cylinders.
• stored to maintain separation between full and empty cylinders.
• used in strict rotation so that cylinders with the earliest filling date are used first.
• stored separately from other medical cylinders within the store 
6.5 Nature and contents of container
A summary of Medical Carbon Dioxide cylinders, their size and construction, type of valve fitted is detailed below:


Cylinders
Content           Structure                                Valve
Cylinder size                                           Valve type quantity           material                               material 0.5-50 liter     0.5-32 kg          Aluminum/       pin , 4496UNI            brass Steel        ,CO2 index
DIN6/UNI11144


Cylinders Bundles
Cylinders Bundles size                               Structure                            Valve Content quantity                       Valve type material                            material
Steel          UNI/ 4496           brass
24m3-480m3                  162-700 kg                       DIN 6/UNI11144



All cylinders used for the storage of Carbon Dioxide are manufactured from high tensile steel with a designed working pressure of at least 137 bar g. All cylinders require an appropriate regulator to be fitted prior to use.

The colour coding of the cylinder body according Israeli standard ISO 712 . Cylinders also carry the carbon dioxide name on the body of the cylinder.

Cylinder Valves
Medical Carbon Dioxide cylinders are supplied with two main types of cylinder valves.
Medical Carbon Dioxide small cylinders are fitted with valves with outlet connections pin index/Din 6
Big size cylinders are fitted with outlet connections W21.7X1/14" (DIN6) and are filled with liquid to a specified weight.
6.6 Special precautions for disposal (and other handling)
All personnel handling Carbon Dioxide cylinders should have adequate knowledge of:
• properties of the gas 
• correct operating procedures for the cylinder

• precautions and actions to be taken in the event of an emergency 
Preparation for Use
To prepare the cylinder for use:
• remove the temper evident seal the valve outlet protection cap. Ensure cap where fitted, is retained so that it can be refitted after use.
• do not remove and discard any batch labels fitted to the cylinder.
• ensure that an appropriate regulator is selected for connection to the cylinder.
• ensure the connecting face on the regulator is clean and the sealing washer fitted is in good condition.
• connect the regulator, using moderate force only and connect the tubing to the regulator / flowmeter outlet. Only the appropriate regulator should be used for the particular gas concerned.
• ensure that the cylinder valves and any associated equipment is not lubricated and kept free from oil and grease

• open the cylinder valve slowly and check for any leaks.

Leaks
Having connected the regulator or manifold yoke to the cylinder check the connections for leaks using the following procedure:
• Should leaks occur this will usually be evident by a hissing noise.
• Should a leak occur between the valve outlet and the regulator or manifold yoke, depressurise and remove the fitting and fit an approved sealing washer.
Reconnect the fitting to the valve with moderate force only, fitting a replacement regulator or manifold tailpipe as required.
• Sealing or jointing compounds must never be used to cure a leak.
• If leak persists, label cylinder and return to Maxima Company Use of Cylinders
When Medical Carbon Dioxide cylinders are in use ensure that they are:
• only used for medicinal purposes.
• turned off, when not in use, using only moderate force to close the valve
• only moved with the appropriate size and type of trolley or handling device.
• handled with care and not knocked violently or allowed to fall.
• firmly secured to a suitable cylinder support when in use.
• not allowed to have any markings, labels or batch labels obscured or removed 
• not used in the vicinity of persons smoking or near naked lights.
After use
When the Medical Carbon Dioxide cylinders are empty ensure that the:
• cylinder valves is closed using moderate force only and the pressure in the regulator or tailpipe released.
• valve outlet cap, where fitted, is replaced
• empty cylinders are immediately returned to an empty cylinder storage area for return to Maxima.
ADMINISTRATIVE DATA