PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Gas Cylinder

1. NAME OF THE MEDICINAL PRODUCT

Medicinal Air Synthetic SOL 21.75% v/v medicinal , compressed

Oxygen 21.75% v/v.

2. STATEMENT OF ACTIVE SUBSTANCE(S)

21.75% v/v.

3. LIST OF EXCIPIENTS

Excipient:

4. PHARMACEUTICAL FORM AND CONTENTS

Medicinal gas, compressed at 200 bar.

Each litre of synthetic air at 200 bar and 15°C delivers 196 litres of air at 1 bar and 15 °C.

Content of the cylinders:

5. METHOD AND ROUTE(S) OF ADMINISTRATION

For inhalation use.

Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Reserved for medicinal use only. • Avoid all contact with grease, oil and . • Do not use if visibly damaged or suspected of having been damaged or exposed to extreme temperatures. • Do not use pliers or other tools to open or close cylinder valve • No change to form of cylinder packaging must be made. • No smoking or naked flames near gas cylinder. • The siphoning of gas under pressure is not permitted. • In of leakage, close cylinder valve if safe to do so. If not, leave cylinder to empty itself in a safe place in open air. • Contains gas under pressure; may explode if heated.

[The warning symbols and text are mentioned on a separate ].

8. EXPIRY DATE

Expiry date [The expiry date is mentioned on a separate label].

9. SPECIAL STORAGE CONDITIONS y Store between -20°C and +65°C. y Store in vertical position. For cylinders with rounded base, store horizontally or in . y Protect from falling or shock. y Protect from sunlight. Store in a well ventilated room. y Store cylinders containing different gas or composition separately. y Store full and empty gas cylinders separately. y Store cylinders under cover and protected against effects of weather. y Keep away from combustible materials. y Keep away from sources of heat.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

Return cylinders to supplier when empty.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Marketing Authorisation Holder: SOL SpA Via Borgazzi, 27 20900 Monza Italy

Local representative

12. MARKETING AUTHORISATION NUMBER(S)

Marketing Authorisation Number:

13. BATCH NUMBER

Batch number [The batch number is mentioned on a separate label].

14. GENERAL CLASSIFICATION FOR SUPPLY

Not subject to medical prescription.

15. INSTRUCTIONS ON USE

Medicinal Air Synthetic SOL is used to prevent deficiency where treatment with atmospheric air is indicated.

Use only as instructed with suitable equipment. Medicinal air is administered via a special device (nasal catheter, face mask, with a hood covering the head or by a into windpipe).

BEFORE USE • Remove tamper evident seal • Ensure connecting faces are clean • Check sealing washer condition • Open cylinder valve slowly • Check for leaks

AFTER USE • Close cylinder valve when not in use, even if cylinder is empty • Close valve slowly with moderate force

Keep connections for tubes, valves etc. clean and dry. Clean the equipment according to the supplier’s instructions. Do not use any solvents. Use clean, lint-free cloth only.

Read the package leaflet before use.

16 INFORMATION IN BRAILLE