AERIS MEDICAL MEDICAL E.P. GRADE COMPRESSED OXYGEN oxygen 100% v/v gas medicinal (gas cylinder)

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Osta kohe

Infovoldik Infovoldik (PIL)
15-10-2020
Toote omadused Toote omadused (SPC)
07-12-2020
Avaliku hindamisaruande Avaliku hindamisaruande (PAR)
30-11-2017

Toimeaine:

oxygen, Quantity: 100 % v/v

Saadav alates:

Supagas Pty Ltd

INN (Rahvusvaheline Nimetus):

Oxygen

Ravimvorm:

Gas, medicinal

Koostis:

Excipient Ingredients:

Manustamisviis:

Inhalation

Ühikuid pakis:

10300 Litres (Size G), 4000 Litres (Size ER), 4000 Litres (Size E), 1800 Litres (Size DF), 1700 Litres (Size DR), 1700 Litres (Size D), 410 Litres (Size CR), 620 Litres (Size CXR), 61800 Litres (Size G), 123600 Litres (Size G), 760 Litres (Size CL), 275 Litres (Size B), 275 Litres (Size BR), 470 Litres (Size C)

Retsepti tüüp:

Not scheduled. Not considered by committee

Näidustused:

Oxygen for medical use. To increase supply of oxygen to the lungs. For respiratory support where there is a requirement for medical oxygen to treat or prevent hypoxemia.

Toote kokkuvõte:

Visual Identification: Colourless gas; Container Type: Gas Cylinder; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius

Volitamisolek:

Registered

Loa andmise kuupäev:

2008-01-07

Infovoldik

                                Aeris Medical Medical Oxygen
2
AERIS MEDICAL MEDICAL E.P. GRADE COMPRESSED
OXYGEN
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
WARNING: Oxygen strongly supports combustion (including some materials
which do not normally burn in
air). Do not smoke, avoid open flames and contact with oils, greases
and tarry substances.
The full CMI on the next page has more details. If you are worried
about using Medical Oxygen, speak to
your doctor, nurse or pharmacist.
1.
WHY AM I USING AERIS MEDICAL MEDICAL OXYGEN?
Aeris Medical Medical Oxygen contains the active ingredient Oxygen.
Medical Oxygen is used to supply
oxygen to the lungs and to help breathing when not enough oxygen is
getting to the lungs.
For more information, see Section 1. in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE AERIS MEDICAL MEDICAL OXYGEN?
If you are planning to use Medical Oxygen at home:
- Do not use if you smoke and intend to continue smoking
- Do not use if you have trouble breathing but it is not due to a lack
of oxygen in the lungs
- Only use if your doctor has said it is OK for you to use
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE
PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
When some medicines are taken when oxygen is used there may be serious
side effects.
A list of these medicines is in Section 3. in the full CMI.
4.
HOW DO I USE AERIS MEDICAL MEDICAL OXYGEN?
•
You will receive Medical Oxygen via a mask or nasal prongs (tubes).
Your doctor will decide how much
you can have
•
You can use nasal sprays containing saline, or a water-based lubricant
to help prevent getting a stuffy,
bleeding or dry nose
More instructions can be found in Section 4. in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING AERIS MEDICAL MEDICAL OXYGEN?
THINGS YOU SHOULD DO
•
Remind any doctor or pharmacist you visit that you are using this.
•
Make sure the cylinder is secured so that it does not fall over.

                                
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Toote omadused

                                1
AUSTRALIAN PRODUCT INFORMATION- AERIS MEDICAL
MEDICAL E.P. GRADE COMPRESSED OXYGEN (OXYGEN)
MEDICINAL GAS
WARNING: OXYGEN AIDS AND INCREASES COMBUSTION
.
Oxygen strongly supports combustion (including some materials which do
not
normally burn in air). Smoking is prohibited when Medical Oxygen is in
use, and no
naked flame is allowed
There is a high risk of spontaneous combustion if oxygen comes into
contact with
oils, greases and tarry substances.
See sections 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE and 4.2 DOSE
AND METHOD OF
ADMINISTRATION: HANDLING AND INSTRUCTIONS FOR USE.
1
NAME OF THE MEDICINE
Oxygen.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gas cylinder contains oxygen 100% v/v.
3
PHARMACEUTICAL FORM
Medicinal gas.
Odourless, colourless gas.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oxygen for medical use.
−
To increase supply of oxygen to the lungs.
−
For respiratory support where there is a requirement for medical
oxygen to treat or
prevent hypoxemia.
4.2
DOSE AND METHOD OF ADMINISTRATION
Oxygen is administered by inhalation through the lungs. The major
exception is when a
metered supply is fed into the oxygenator of an extracorporeal
circulation of a cardio-
pulmonary by-pass system.
DOSAGE
Inhaled medical oxygen must be administered using an appropriate
pressure reduction device
and equipment such as mask or nasal prongs to deliver the required
inspired concentration of
oxygen,
between
21%
and
100%,
as
determined
by
the
prescriber
after
full
clinical
assessment. Most delivery systems for adults result in an inspired
oxygen concentration of
60% or less.
Inhaled oxygen may require humidification when treatment duration is
longer than an hour.
Nasal symptoms, such as nasal stuffiness, dryness or bleeding may be
alleviated by the use
of nasal saline sprays or water-based lubricant.
2
Standard texts and clinical protocols should be consulted for the
oxygen requirements specific
to the underlying condition and the clinical status of the individual
patient. It is essential to
monitor
                                
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