Oxin

Patient Information Leaflet: Information for the User

OXiN, compressed medical gas
Oxygen 21.0 – 22.4% v/v
Please read all of this leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Table of Contents

1. What OXiN is and what it is used for
2. Important information before using OXiN
3. How to use OXiN
4. Possible side effects
5. How to store OXiN
6. Contents of the pack and other information

1. What OXiN is and what it is used for

OXiN is a medical gas supplied in pressurized gas cylinders.
The medicinal product belongs to the group "Other therapeutic agents, medical gases".
Ambient (atmospheric) air is replaced by OXiN in specific situations, including:

• to provide a flow of fresh gas during ventilatory therapy;
• to provide a flow of fresh gas during anaesthesia;
• as a carrier gas for nebulization.

2. Important information before using OXiN

When not to use OXiN:
There are no restrictions regarding the use of OXiN under normal atmospheric pressure.
Warnings and precautions:
Before starting to use OXiN, consult your doctor.
Improper use and handling of compressed medical air gas may cause harmful health effects due to gas pressure.
Children
Warnings and precautions in children and adolescents are the same as in adults.
OXiN and other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
OXiN with food, drink and alcohol
Food, drink and alcohol do not affect the use of OXiN.
Pregnancy, breastfeeding and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine. The product may be used by women of childbearing age. OXiN may be used during pregnancy and breastfeeding.
Driving and operating machinery
OXiN does not affect patients' ability to drive or operate machinery.

3. How to use OXiN

This medicine should always be used as directed by the physician. In case of doubt, consult
your doctor or pharmacist. OXiN may be used in children of any age, adults,
and elderly patients.
OXiN is a gas administered by inhalation using a nasal cannula or face mask. The patient
can inhale it spontaneously (by normal breathing) or with the aid of a
ventilator/respirator. OXiN may also be used in inhalation therapy (nebulization).
OXiN can be mixed with medical oxygen if a higher oxygen concentration is required.
There is no established recommended dose. The dose is determined individually by the physician for each patient.
Use in children
OXiN can be used in the same manner in children, adolescents, and adults.
Use of a higher than recommended dose of OXiN
Use of OXiN does not carry a risk of overdose. Medical air should always
be administered according to recommendations, using equipment intended for this purpose.
If you have any questions regarding the use of the medicinal product, consult your
doctor.
Instructions for storage and handling of gas cylinders are provided in section 5.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
No adverse reactions related to the use of OXiN have been reported when the product is administered using the appropriate device.
If any adverse reactions occur during or after administration of the medicinal product, they should be reported to a doctor.

Additional adverse reactions in children and adolescents
No additional adverse reactions have been reported in children and adolescents.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor.
Adverse reactions can be reported directly to:
Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions enables better assessment of the safety profile of the medicine.

5. How to store the OXiN medicine

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the gas cylinder after the abbreviation
"Exp". The expiry date refers to the last day of the specified month.
Special precautions during storage

• Smoking and the use of open flames are prohibited in rooms where medical gases are stored or administered.
• Gas cylinders must be stored in a location designated for the storage of medical gases.
• Cylinders should be stored in a sheltered place, away from flammable substances, protected from weather conditions and exposure to extreme temperatures. Cylinders must be clean and dry.
• For cylinders equipped with integrated valves, prepare for replacement when the indicator enters the yellow zone and replace when the indicator reaches the red zone.
• Appropriate precautions should be taken to prevent the gas cylinder from being subjected to impact or falling.
• Cylinders containing different gases must be stored separately.
• Full and empty gas cylinders must be stored separately.
• After delivery of the cylinder from the manufacturer, check whether the plastic valve guard is intact.
• Gas cylinders must be stored at temperatures ranging from -40 °C to +65 °C.

After the expiry date, return the cylinder to the supplier.

6. Contents of the packaging and other information

What OXiN contains

• The active substance in the medicine is oxygen (chemical symbol O)
• The remaining component (excipient) is nitrogen (chemical symbol N)

OXiN is administered to patients instead of normal atmospheric air in justified
medical circumstances. OXiN contains oxygen (chemical symbol O) at a concentration of 21.0–22.4%
v/v, as well as nitrogen (chemical symbol N). Oxygen is the pharmacologically active substance, and nitrogen is
an excipient.
OXiN does not contain any other ingredients.
What OXiN looks like and contents of the packaging
Pharmaceutical form: compressed medical gas.
OXiN is a colourless, tasteless and odourless gas.
OXiN is stored in steel or aluminium cylinders fitted with valves made of brass.
Cylinder colour markings
Upper, spherical part of the cylinder: white stripe RAL number: 9010
black stripe RAL number: 9005
Cylindrical part of the cylinder: white RAL number: 9010

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Linde gas a. s.
U Technoplynu 1324
19800 Prague 9
Czech Republic
Manufacturer
Linde gas a. s.
U Technoplynu 1324
19800 Prague 9
Czech Republic
Linde Gas Hungary
CoCLtd.
Budai Nagy Antal út 7
Dunaújváros, 2400
Hungary
Linde Hellas Single Person LLC. (Mandra Attiki)
Thesi Tripio Lithari,
19600 Mandra Attiki,
Greece
This medicinal product is authorised for marketing in the European Economic Area countries under the following names:
Czech Republic Vzduch medicinální syntetický Linde
Croatia Medicinski sintetični zrak Linde, medicinski plin, stlačeni
Hungary Szintetikus levegő Linde túlnyomásos orvosi gáz
Poland OXiN
Slovakia Vzduch medicinálny syntetický Linde
Slovenia Sintetični medicinski zrak Linde Gas 21,0-22,4 % medicinski plin, stisnjeni
Greece Φαρμακευτικός Συνθετικός Αέρας/Linde