AIR SYNTHETIC MEDICINAL

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

OXYGEN

Available from:

MAXIMA AIR SEPARATION LTD, ISRAEL

ATC code:

V03AN01

Pharmaceutical form:

GAS - MEDICINAL, COMPRESSED

Composition:

OXYGEN 21.0 - 22.5 %V/V

Administration route:

INHALATION

Prescription type:

Required

Manufactured by:

MAXIMA AIR SEPARATION CENTER LTD, ISRAEL

Therapeutic area:

OXYGEN

Therapeutic indications:

Gas for inhalation

Authorization date:

2018-12-18

Summary of Product characteristics

_This leaflet format has been determined by the Ministry of Health and
the content has been _
_checked and approved in December 2018_
_ _
Physician Prescribing Information
Air, Synthetic Medicinal
Summary of Product Characteristics (SPC)
1. NAME OF THE MEDICINAL PRODUCT
Air, Synthetic Medicinal
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Medical air specification.
oxygen content: 21.0%- 22.5% v/v
The medical air cylinder specification complies with the European
Pharmacopoeia
monograph (1684).
3. PHARMACEUTICAL FORM
Medicinal gas, compressed.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Gas for Inhalation
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For breathing purposes medical air is administered by various means,
commonly by
self contained or compressed air line breathing apparatus. In
anaesthesia, medical
air is administered via a cylinder and valve assembly through a face
mask or
endotracheal tube.
4.3 CONTRAINDICATIONS
Medical air is contraindicated where oxygen or other gaseous
combinations would
be indicated (airways obstruction, pneumonia, and a myriad of
cardio-respiratory
conditions).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Medical air should never be administered to a patient if, when it is
mixed with other
gases, the oxygen content is less than 21%.
Care is needed in the handling and use of medical air cylinders.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None applicable.
4.6 PREGNANCY AND LACTATION
Medical air does not adversely affect pregnancy and lactation.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
The use of medical air does not affect the ability to drive or use
machinery.
4.8 UNDESIRABLE EFFECTS
None applicable.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the
medicinal product is
important. It allows continued monitoring of the benefit/risk balance
of the medicinal
product. Any suspected adverse events should be reported to the
Ministry of Health
according to the National Regulation by u