Coregas Pty Ltd medical oxygen 100% v/v gas in gas cylinder

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

oxygen, Quantity: 100 % v/v

Available from:

Coregas Pty Ltd

INN (International Name):

Oxygen

Pharmaceutical form:

Gas, medicinal

Composition:

Excipient Ingredients:

Administration route:

Inhalation

Units in package:

B 1.4L, E 23L, 12 pack 600L = 12 x 50 L G, C 2.8L, 6 pack 300L = 6 x 50 L G, G 50L, D 9.5L

Class:

Medicine Registered

Prescription type:

Not Scheduled after consideration by Committee, Not scheduled. Not considered by committee

Therapeutic indications:

? Hypoxia of any cause. ? As diluent for gaseous and volatile anaesthetic agents.

Product summary:

Visual Identification: Gas; Container Type: Gas Cylinder; Container Material: Steel

Authorization status:

Licence status A

Authorization date:

1992-01-02

Patient Information leaflet

COREGAS PTY LTD MEDICAL OXYGEN
1
COREGAS PTY LTD MEDICAL OXYGEN 100% V/V GAS IN
GAS CYLINDER MEDICINAL GAS
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, dentist,
nurse or pharmacist.
1.
WHY AM I HAVING COREGAS PTY LTD MEDICAL OXYGEN?
Coregas Pty Ltd Medical Oxygen contains the active ingredient Oxygen.
Medical Oxygen is used to help breathing when your
lungs are not getting enough oxygen, and it is also used for mixing
with anaesthetic gases. For more information, see Section 1.
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I HAVE COREGAS PTY LTD MEDICAL OXYGEN?
•
Do not use this if you smoke and plan to keep smoking
•
Only use this if your doctor or dentist has said it is OK for you to
use it
TALK TO YOUR DOCTOR OR DENTIST IF YOU HAVE ANY OTHER MEDICAL
CONDITIONS, OR ARE PREGNANT OR PLANNING TO BECOME PREGNANT OR
ARE BREASTFEEDING OR PLANNING TO BREASTFEED.
For more information, see Section 2. in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Tell your doctor or dentist if you are taking any other medicines,
especially bleomycin or amiodarone.
See Section 3. in the full CMI.
4.
HOW DO I HAVE COREGAS PTY LTD MEDICAL OXYGEN?
You will receive Medical Oxygen via a mask or nasal prongs (tubes).
Your doctor or dentist will decide how much you can have.
More instructions can be found in Section 4. in the full CMI.
5.
WHAT SHOULD I KNOW WHILE HAVING COREGAS PTY LTD MEDICAL OXYGEN?
THINGS YOU SHOULD DO
•
Remind any doctor, dentist, nurse or pharmacist treating you that you
are using this
•
Tell them if you feel that you are not receiving enough oxygen, or if
you hear a hissing
sound coming from the cylinder
•
Make sure the cylinder is secured so that it does not fall over.
THINGS YOU MUST NOT DO
•
Nev

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – COREGAS PTY LTD
MEDICAL OXYGEN 100% V/V GAS IN GAS CYLINDER
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 6.4
SPECIAL
PRECAUTIONS FOR STORAGE.
1
NAME OF THE MEDICINE
Oxygen.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Oxygen 100%.
3
PHARMACEUTICAL FORM
Medical gas.
Colourless, odourless gas.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
•
Hypoxia of any cause.
•
As diluent for gaseous and volatile anaesthetic agents.
4.2
D
OSE AND METHOD OF ADMINISTRATION
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 ventilation, arterial oxygen saturation, and the clinical
effect of the treatment.
The dose (Fi0
2
) must be adjusted according to each patient's individual needs,
taking into
account the risk of oxygen toxicity.
The general recommendation is to use the lowest dose necessary to
achieve the desired result
of treatment. _ _
In patients with chronic respiratory disorders with hypercapnia, there
is a risk of reduced
respiratory drive with high oxygen concentrations.
Oxygen treatment must be continuously evaluated.
Coregas Pty Ltd medical oxygen 100% should not be used for hyperbaric
oxygen treatment.
2
USE IN ADULTS AND CHILDREN
For respiratory use at concentrations of greater than 21%.
USE IN NEONATES
Treatment of neonates with oxygen may be required but must be strictly
monitored, so that
the oxygen concentration may be reduced when the patient's condition
allows. For neonates
(full-term
and
preterm)
the
appropriate
institutional
protocols,
based
on
full
clinical