Medicinal air synthetic SOL 21.75% v/v medicinal gas, compressed

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Oxygen

Available from:

SOL S.p.A.

ATC code:

V03AN; V03AN01

INN (International Name):

Oxygen

Dosage:

21.75 percent volume/volume

Pharmaceutical form:

Medicinal gas, compressed

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Medical gases; oxygen

Authorization status:

Authorised

Authorization date:

2016-05-20

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
MEDICINAL AIR SYNTHETIC SOL 21.75% V/V MEDICINAL GAS, COMPRESSED
Oxygen
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Medicinal air synthetic SOL is and what it is used for
2.
What you need to know before you use Medicinal air synthetic SOL
3.
How to use Medicinal air synthetic SOL
4.
Possible side effects
5.
How to store Medicinal air synthetic SOL
6.
Contents of the pack and other information
1.
WHAT MEDICINAL AIR SYNTHETIC SOL
IS AND WHAT IT IS USED FOR
Medicinal air synthetic SOL is an inhalation gas and belongs to the
group of medicinal gases.
This medicine is used to prevent oxygen deficiency where treatment
with atmospheric air is
indicated.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MEDICINAL AIR SYNTHETIC SOL
DO NOT USE MEDICINAL AIR SYNTHETIC SOL
There are no known situations in which this medicine cannot be used.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using this medicine.

Before treatment with medicinal air, ensure that it is administered at
atmospheric pressure.

The administration of pressurised medicinal air may cause
decompression sickness and
oxygen toxicity. Decompression sickness is a disease that occurs
during the transition from
high pressure to normal pressure and causes headache, nausea, and
confusion, and
sometimes paralysis and un-consciousness (and even death).

If medicinal air is mixed with other inhalational gases, there should
be sufficient oxygen (at
least 21% v/v) in this gas mixture.

Summary of Product characteristics

Health Products Regulatory Authority
20 November 2019
CRN008PP9
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Medicinal air synthetic SOL 21.75% v/v medicinal gas, compressed
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Oxygen 21.75% v/v.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Medicinal gas, compressed
Medicinal Air Synthetic is a colourless, odourless and tasteless gas.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prevention of hypoxia where treatment with atmospheric air is
indicated.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The flow rate and duration of administration should be determined
based on the cause of the hypoxia.
Method of administration
A physician, experienced in intensive care or pneumology, should see
to the administration of medicinal air as inlet gas for
respirators used in respiratory support.
For long-term administration, humidification is advised.
Medicinal air is administered via inhaled air, preferably by means of
dedicated equipment (for example, a nasal cannula, facial
mask, facial tent, an oxygen tent over a crib, or flow to
tracheotomy). Such devices must be used according to the instructions
of the manufacturer. Through this equipment, medicinal air is
administered along with inhaled air. Upon exhaling, the exhaled
gas leaves the patient together with any surplus air and mixes with
the ambient air (“non-rebreathing” system).
If the patient is not able to breathe independently, artificial
breathing support can be provided.
General
Connections for tubes, valves, etc., must be clean and dry. If needed,
clean them according to the instructions of the supplier.
Do not use solvents.
Do not use oil or grease on the cylinder valve or the related
equipment.
4.3 CONTRAINDICATIONS
There are no absolute contraindications.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Medicinal air may only be administered to patients under atmospheric
pressure or at pressure levels that are slightly positive,
when ventilators are u