Oxin

PATIENT INFORMATION LEAFLET

Leaflet enclosed with the packaging: information for the user

OXiN, compressed medical gas

Oxygen 21.0 – 22.4% v/v

Please read carefully the contents of the leaflet before using the medicine, as it contains

important information for the patient.

• Please keep this leaflet, you may need to read it again.
• In case of any doubts, please consult a doctor or pharmacist.
• The medicine has been prescribed specifically for one person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is OXiN and what is it 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 packaging and other information

1. What is OXiN and what is it used for

OXiN is a medical gas supplied in compressed gas cylinders under pressure.
The medicinal product belongs to the group "Other medicinal products, medical gases".
Natural ambient air (atmospheric) is replaced with OXiN in certain situations, including:

• to ensure the flow of fresh gas during ventilatory therapy;
• to ensure the flow of fresh gas during anesthesia;
• as a carrier gas for nebulization.

2. Important information before using OXiN

When not to use OXiN:

There are no restrictions on the use of OXiN at normal atmospheric pressure.

Warnings and precautions:

Before starting to use OXiN, please discuss it with your doctor.
Incorrect use and handling of compressed medical gas can cause harmful health effects due to gas pressure.

Children

Warnings and precautions for children and adolescents are the same as for adults.

OXiN and other medicines

Please tell your doctor about all medicines you are 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 or breastfeeding, think you may be pregnant, or plan to have a child, please 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 using machines

OXiN does not affect the patient's ability to drive or operate machinery.

3. How to use OXiN

This medicine should always be used as directed by your doctor. In case of doubts, please consult your doctor or pharmacist. OXiN can be used in children of any age, adults, and elderly patients.
OXiN is an inhaled gas administered via a nasal cannula or face mask. The patient can inhale it on their own (breathing freely) or with the use of a respirator/ventilator. OXiN can 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 by the doctor individually for each patient.

Use in children

OXiN can be used in the same way in children, adolescents, and adults.

Using a higher dose of OXiN than recommended

Using OXiN is not associated with the risk of overdose. Medical air should always be administered according to the recommendations, using a device intended for this purpose.
In case of any questions about the use of the medicinal product, please consult your doctor.
Recommendations for the storage and handling of gas cylinders can be found in section 5.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
No side effects have been reported in connection with the use of OXiN when it is administered using the appropriate device.
If any side effects occur during or after using the medicinal product, please inform your doctor.

Additional side effects in children and adolescents

There are no additional side effects in children and adolescents.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, please inform your doctor.
Side effects can be reported directly to:
Department for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store OXiN

The medicine should be stored 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 month stated.

Special precautions for storage

• In rooms where medical gases are stored or administered, smoking or using open fire is prohibited.
• Gas cylinders should be stored in a designated area for medical gas storage.
• Cylinders should be stored in a sheltered area, away from flammable substances, protected from atmospheric factors and extreme temperatures. Cylinders should be clean and dry.
• In the case of cylinders equipped with integrated valves, prepare for replacement when the indicator is in the yellow field and replace when the indicator reaches the red field.
• Take appropriate precautions to prevent the gas cylinder from being exposed to impacts or falls.
• Cylinders containing different gases should be stored separately.
• Full and empty gas cylinders should be stored separately.
• After delivery of the cylinder from the manufacturer, check if the valve cover made of plastic is intact.
• Gas cylinders should be stored at a temperature between -40 °C and +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 of the medicine is oxygen (chemical symbol O)
• The other ingredient (excipient) is nitrogen (chemical symbol N)

OXiN is administered to patients instead of normal atmospheric air in justified medical situations. OXiN contains oxygen (chemical symbol O) at a concentration of 21.0 – 22.4% v/v and nitrogen (chemical symbol N). Oxygen is a pharmacologically active substance, and nitrogen is an excipient.
OXiN does not contain any other ingredients.

What OXiN looks like and what the packaging contains

Pharmaceutical form: compressed medical gas.
OXiN is a colorless, odorless, and tasteless gas.
OXiN is stored in steel or aluminum cylinders equipped with brass valves.

Colors of cylinder labeling

Upper, spherical part of the cylinder
white stripe
black stripe
RAL number: 9010
RAL number: 9005
Cylindrical part of the cylinder
white
RAL number: 9010

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 authorized in the Member States of the European Economic Area 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

Date of last revision of the leaflet: