INOMAX 400 PPM Inhalation gas

Зміст інструкції

1. INOmax 400 ppm mol/mol Compressed medicinal gas
   1. What is INOmax and what is it used for
   2. What you need to know before using INOmax
   3. How INOmax is administered
   4. Possible side effects
   5. How to store INOmax
   6. Contents of the pack and other information
2. INOmax 800 ppm mol/mol Compressed medicinal gas
   1. What is INOmax and what is it used for
   2. What you need to know before using INOmax
   3. How to use INOmax
   4. Possible side effects
   5. How to store INOmax
   6. Contents of the pack and other information

INOmax 400 ppm mol/mol Compressed medicinal gas

Nitric oxide

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• If any side effects occur, including those not listed in this leaflet, tell your doctor. (See section 4)

Contents of this leaflet:

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

1. What is INOmax and what is it used for

INOmax contains nitric oxide, a gas used for the treatment of:

• newborns affected by neonatal pulmonary hypertension associated with high blood pressure in the lungs, a condition called hypoxic respiratory failure. When inhaled, this gaseous mixture improves blood circulation through the lungs, increasing the amount of oxygen reaching the baby's blood.
• newborns, children, adolescents aged from 0 to 17 years and adults with high blood pressure in the lungs, related to cardiac surgery. This gaseous mixture can improve cardiac function and increase blood flow to the lungs, consequently helping to increase the amount of oxygen that reaches the blood.

2. What you need to know before using INOmax

Do not use INOmax:

• If you (as a patient) or the child (as a patient) are allergic (hypersensitive) to nitric oxide or any of the excipients of INOmax. (see section 6 “Further information”, containing the complete list of ingredients).
• If you (as a patient) or the child (as a patient) have abnormal blood circulation within the heart.

Take special care with INOmax
Inhaled nitric oxide may not always be effective and therefore other therapies may be
considered necessary for you or the child.
Inhaled nitric oxide may alter the blood's ability to carry oxygen. This effect will be monitored with blood samples and, if necessary, the dose of inhaled nitric oxide will be reduced.
Nitric oxide can react with oxygen to form nitrogen dioxide, which can cause irritation
of the airways. The doctor or pediatrician will monitor nitrogen dioxide levels and, if
they are high, INOmax therapy will be adjusted and reduced accordingly.
Inhaled nitric oxide may have a weak effect on platelets (components that
contribute to blood clotting) and therefore any symptoms of
bleeding or bruising in you or the child should be monitored. If any signs or symptoms that may
be associated with bleeding are detected, inform the doctor immediately.
No effects of inhaled nitric oxide have been documented in newborns with malformations
due to an incomplete diaphragm, the so-called “congenital diaphragmatic hernias”.
In newborns with particular heart malformations, those that doctors call “congenital heart
defects”, inhaled nitric oxide may worsen circulation.

Children
INOmax should not be administered to premature babies with less than 34 weeks of gestation.

Other medicines and INOmax:
The doctor will decide when to treat you or the child with INOmax and with other medications, under close
supervision of the treatment.
Tell the doctor if you (as a patient) or the child (as a patient) are taking or have recently
taken or used other medicines, including those without a prescription.
Some medications may affect the blood's ability to carry oxygen. These include
prilocaine (a local anesthetic used to relieve pain from minor painful procedures such as
sutures and minor diagnostic or surgical procedures) or glyceryl trinitrate (used for
treating chest pain). The doctor will check that the blood can carry enough oxygen
while taking these medications.

Pregnancy and breastfeeding
The use of INOmax during pregnancy and breastfeeding is not recommended. Before starting treatment
with INOmax, tell the doctor if you are pregnant, or think you may be, or if you are breastfeeding.
Before taking any medication, ask your doctor or pharmacist for advice.

Driving and using machines
Not applicable.

INOmax contains nitrogen

3. How INOmax is administered

The doctor will decide the correct dose of INOmax and will administer INOmax to the patient's lungs
through a system designed for this purpose. This system will ensure the administration of the correct
amount of nitric oxide by diluting INOmax with an oxygen/air mixture immediately before
administration.
For your safety and that of the child, the systems provided for the administration of INOmax
have devices that constantly measure the amount of nitric oxide, oxygen and nitrogen dioxide (a
chemical formed by mixing nitric oxide and oxygen) delivered to the lungs.
The doctor will decide the duration of treatment with INOmax.
INOmax is administered in doses of 10 to 20 ppm (maximum dose 20 ppm in children and 40 ppm in
adults), i.e. parts per million to be inhaled. The minimum effective dose will be identified. Therapy is
usually necessary for about 4 days in neonates with respiratory failure associated with
high blood pressure in the lungs. In children and adults with high pulmonary blood pressure,
related to cardiac surgery, INOmax is usually administered for

• 24 – 48 hours. However, therapy with INOmax may last longer.

If you or the child have taken more INOmax than you should
Excessive inhalation of nitric oxide can affect the blood's ability to carry
oxygen. This will be monitored through blood samples and if necessary the dose of INOmax will be
reduced; the administration of medications such as vitamin C
or methylene blue, or possibly a blood transfusion, may be considered in order to improve the ability to
carry oxygen in the blood.

If you stop treatment with INOmax
Treatment with INOmax should not be stopped abruptly. It is known that if you stop the
treatment with INOmax suddenly without first reducing the dose, a decrease occurs
in blood pressure or a return of increased pulmonary pressure.
At the end of treatment, the doctor will slowly lower the amount of INOmax administered to you
or the child so that the circulation in the lungs can adjust to oxygen/air without INOmax.
Therefore, it may take a day or two before you or the child completely stop the
INOmax therapy.
If you have any questions about the use of this medicine, please ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The doctor will carefully examine you or your child to check for the absence of any side effects.
The very commonly observed side effects (more than 1 in 10 patients)in relation to therapy with INOmax include:

• Low platelet count.

The commonly observed side effects (more than 1 in 100 patients)in relation to therapy with
INOmax include:

• Low blood pressure, collapsed or oxygen-deprived lung.

Observable, but uncommon side effects (between 1 in 100 and 1 in

• 1,000)include:
• Increased methemoglobin, with reduced oxygen carrying capacity.

Observable side effects with unknown frequency ( frequency cannot be estimated based on

available data) are:

• Bradycardia (slow heart rate) or too low oxygen levels in the blood (oxygen desaturation/hypoxia) due to sudden interruption of treatment.
• Headache, dizziness, sore throat, or shortness of breath following accidental environmental exposure to nitric oxide (e.g. following a leak from equipment or the cylinder).

Immediately inform staff if a headache is detected when near the
child undergoing therapy with INOmax.
If any side effect gets worse, or if you notice any side effect not listed in this leaflet, even after your or the child’s discharge, inform the doctor.

Reporting of side effects
If you get any side effects, talk to your doctor. You can also report side effects directly through the national reporting system as detailed in Appendix V.
By reporting side effects you can help to provide more information on the safety of
this medicine.

5. How to store INOmax

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label preceded by the abbreviation
EXP. The expiry date refers to the last day of the month indicated.
Therapy with INOmax must be performed and managed exclusively by hospital personnel.

• INOmax cylinders must be stored securely to prevent them from falling and therefore the risk of potential injury.
• INOmax must be used and administered exclusively by personnel specifically trained in the use and handling of INOmax.

Observe all rules pertaining to the handling of pressurized cylinders.
Storage takes place under the supervision of specialists at the hospital. Store the gas cylinders in well-ventilated areas, or in ventilated sheds protected from rain and exposure to direct sunlight.

Protect gas cylinders from impacts, falls, oxidation and flammable materials, humidity,
sources of heat or ignition.

Storage in the pharmacy department
Store gas cylinders in a well-ventilated, clean and locked place, reserved exclusively for the storage of medicinal gases. Within this room, assign a separate area for the storage of nitrous oxide cylinders.

Storage in the medical department
Place the gas cylinder in an equipped site, with appropriate material to keep the cylinder in an upright position.
When the cylinder is empty, do not dispose of it. Empty cylinders are collected by the supplier.

6. Contents of the pack and other information

What INOmax contains
The active ingredient of INOmax is nitric oxide 400 ppm mol/mol. A 2-liter cylinder filled
to a pressure of 155 bar absolute provides 307 liters of gas at a pressure of 1 bar at 15 °C.
A 10-liter cylinder filled to a pressure of 155 bar absolute provides 1535 liters of gas at a
pressure of 1 bar at 15 °C.
The excipient is nitrogen.

Description of the appearance of INOmax and contents of the pack
Compressed medicinal gas
A 2-liter aluminum gas cylinder (identification with an aquamarine-colored ogive and a white body), filled to a pressure of 155 bar and equipped with a positive (residual) pressure valve
made of stainless steel with a specific outlet connection and a standard valve knob.
A 2-liter aluminum gas cylinder (identification with an aquamarine-colored ogive and a white body), filled to a pressure of 155 bar and equipped with a positive (residual) pressure valve
made of stainless steel with a specific outlet connection and a valve knob equipped with an
INOmeter device.
A 10-liter aluminum gas cylinder (identification with an aquamarine-colored ogive and a white body), filled to a pressure of 155 bar and equipped with a positive (residual) pressure valve
made of stainless steel with a specific outlet connection and a standard valve knob.
A 10-liter aluminum gas cylinder (identification with an aquamarine-colored ogive and a white body), filled to a pressure of 155 bar and equipped with a positive (residual) pressure valve
made of stainless steel with a specific outlet connection and a valve knob equipped with a
INOmeter device.
INOmax is available in 2-liter and 10-liter aluminum cylinders.

Marketing authorization holder and manufacturer

Marketing authorization holder
Linde Healthcare AB
Rättarvägen 3
169 68 Solna
Sweden

Manufacturer
Linde France
Z.I. Limay-Porcheville
3 avenue Ozanne
78440 Porcheville
France
For further information on this medicinal product, contact the local representative of the marketing
authorization holder:

België/Belgique/Belgien
Linde Gas Belgium N.V.
Westvaartdijk 85
1850 Grimbergen
Tél/Tel.: +32 70 233 826
[email protected]

Lietuva
Linde Gas UAB
Didlaukio g. 69
08300, Vilnius
Tel.: +370 2787787
[email protected]

България
Linde Healthcare AB
Rättarvägen 3
169 68 Solna
Sweden
Tel: +46 8 7311000

Luxembourg/Luxemburg
Linde Gas Belgium N.V.
Westvaartdijk 85
1850 Grimbergen
Tél/Tel.: +32 70 233 826
[email protected]

Česká republika
Linde Gas a.s.
U Technoplynu 1324
198 00 Praha 9
Tel: +420 800 121 121
[email protected]

Magyarország
Linde Gáz Magyarország Zrt.
Illatos út 11/A.
1097 Budapest
Tel.: +36 30 349 2237
[email protected]

Danmark
Linde Gas A/S
Lautruphøj 2-6
2730 Ballerup
Tlf: + 45 70 104 103
[email protected]

Malta
Linde Healthcare AB
Rättarvägen 3
169 68 Solna
Sweden
Tel: +46 8 7311000

Deutschland
Linde GmbH
Dr.-Carl-von-Linde-Straße 6-14
82049 Pullach
Tel: +49 89 7446 0
[email protected]

Nederland
Linde Gas Therapeutics Benelux B.V.
De Keten 7
5651 GJ Eindhoven
Tel: +31 40 282 58 25
[email protected]

Eesti
AS Linde Gas
Valukoja 8
11415 Tallinn
Tel: +372 650 4500
[email protected]

Norge
Linde Gas AS
Postboks 13 Nydalen
0409 Oslo
Tlf. +47 81559095
[email protected]

Ελλάδα
ΛΙΝΤΕ ΕΛΛΑΣ ΜΟΝ ΕΠΕ
Θέση Τρύπιο Λιθάρι
19600 Μάνδρα Αττικής
Τηλ: +30 211-1045500-510
[email protected]

Österreich
Linde Healthcare
Linde Gas GmbH
Modecenterstr.17/ Objekt 1/3.OG
1110 Wien
Tel: +43(0)50.4273-2200
[email protected]

España
Linde Gas España, S.A.U.
Camino de Liria, s/n
46530 Puzol (Valencia)
Tel: +34 900 941 857 / +34 902 426 462
[email protected]

Polska
Linde Gaz Polska Sp. z o.o.
ul. prof. Michała Życzkowskiego 17
31-864 Krakow
Tel.: 0 801 142 748 / +48 (12) 643 92 00
[email protected]

Portugal
Linde Portugal, Lda.
Av. Infante D. Henrique Lotes 21-24
1800-217 Lisboa
Tel: + 351 218 310 420
linde.portugal@ linde.com

Hrvatska
GTG plin d.o.o.
Kalinovac 2/a
47000 Karlovac
Tel. +385 47 609 200

France
Linde France - Activité médicale - Linde
Healthcare
3 avenue Ozanne
Z.I. Limay-Porcheville
78440 Porcheville
Tél:+33 810 421 000
[email protected]

România
Linde Gaz România SRL
str. Avram Imbroane nr. 9
Timisoara 300136 - RO
Tel: +40 256 300 700
[email protected] [email protected]

Ireland
INO Therapeutics UK
185 Carver Drive
Kent Science Park
Sittingbourne
Kent ME9 8NP
Tel: +44 1795 411552
[email protected]

Slovenija
GTG plin d.o.o.
Bukovžlak 65/b
3000 CELJE
Tel: + 386 (0)3 42 60 746
[email protected]

Ísland
Linde Gas ehf
Breiðhöfða 11
110 Reykjavik
Sími: + 354 577 3030
[email protected]

Slovenská republika
Linde Gas s.r.o.
Tuhovská 3
831 06 Bratislava
Tel: +421 2 49 10 25 16
[email protected]

Italia
LINDE MEDICALE S.r.L
Via Guido Rossa 3
20010 Arluno (MI)
Tel : +39 02 903731 / 800 600 633

Suomi/Finland
Oy Linde Gas Ab
Itsehallintokuja 6
02600 Espoo
Puh/Tel: + 358 10 2421
[email protected]

Κύπρος
Linde Hadjikyriakos Gas Ltd
Λεωφόρος Λεμεσού 260, 2029 Στρόβολος
Λευκωσία, Κύπρος.
Τηλ. +357-22482330
[email protected]

Sverige
Linde Gas AB
Rättarvägen 3
169 68 Solna
Tel: + 46 8 7311800
[email protected]

Latvija
Linde Gas SIA,
Katrīnas iela 5
Rīga, 1045
Tel: +371 80005005
[email protected]

United Kingdom
INO Therapeutics UK
185 Carver Drive
Kent Science Park
Sittingbourne
Kent ME9 8NP
Tel: +44 1795 411552
[email protected]

This leaflet was updated on MM/YYYY.
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu/.

INOmax 800 ppm mol/mol Compressed medicinal gas

Nitric oxide

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• If any side effects occur, including those not listed in this leaflet, tell your doctor. (See section 4)

Contents of this leaflet:

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

1. What is INOmax and what is it used for

INOmax contains nitric oxide, a gas used for the treatment of:

• newborns affected by neonatal pulmonary hypertension associated with high blood pressure in the lungs, a condition called hypoxic respiratory failure. When inhaled, this gaseous mixture improves blood circulation through the lungs, increasing the amount of oxygen reaching the baby's blood.
• newborns, children, adolescents aged from 0 to 17 years and adults with high blood pressure in the lungs, related to cardiac surgery. This gaseous mixture can improve cardiac function and increase blood flow to the lungs, thereby contributing to increase the amount of oxygen that reaches the blood.

2. What you need to know before using INOmax

Do not use INOmax:

• If you (as a patient) or the child (as a patient) are allergic (hypersensitive) to nitric oxide or any of the excipients of INOmax. (see section 6 “Further information”, containing the complete list of ingredients).
• If you (as a patient) or the child (as a patient) have abnormal blood circulation within the heart.

Take special care with INOmax
Inhaled nitric oxide may not always be effective and therefore other therapies may be
considered necessary for you or the child.
Inhaled nitric oxide can alter the blood's ability to carry oxygen. This effect will be monitored with blood samples and, if necessary, the dose of inhaled nitric oxide will be reduced.
Nitric oxide can react with oxygen to form nitrogen dioxide, which can cause irritation
of the airways. The doctor or pediatrician will monitor nitrogen dioxide and, if
values are high, INOmax therapy will be adjusted and reduced accordingly.
Inhaled nitric oxide may have a weak effect on platelets (components that
contribute to blood clotting) and therefore any symptom of
bleeding or bruising in you or the child must be monitored. If signs or symptoms that may
be associated with bleeding are detected, inform the doctor immediately.
No effects of inhaled nitric oxide have been documented in newborns with malformations
due to an incomplete diaphragm, the so-called “congenital diaphragmatic hernias”.
In newborns with particular heart malformations, those that doctors call “congenital
heart defects”, inhaled nitric oxide can cause a worsening of circulation.

Children
INOmax should not be administered to premature babies with less than 34 weeks of gestation.

Other medicines and INOmax
The doctor will decide when to treat you or the child with INOmax and with other medicines, under close
supervision of the treatment.
Tell the doctor if you (as a patient) or the child (as a patient) are taking or have recently
taken or used other medicines, including those without a prescription.
Some medicines can affect the blood's ability to carry oxygen. These include
prilocaine (a local anesthetic used to relieve pain from minor painful procedures such as
sutures and minor diagnostic or surgical procedures) or glyceryl trinitrate (used for
treating chest pain). The doctor will check that the blood can carry enough oxygen
while taking these medicines.

Pregnancy and breastfeeding
The use of INOmax during pregnancy and breastfeeding is not recommended. Before starting treatment
with INOmax, tell the doctor if you are pregnant, or think you may be, or if you are breastfeeding.
Before taking any medicine, ask your doctor or pharmacist for advice.

Driving and using machines
Not applicable.

INOmax contains nitrogen.

3. How to use INOmax

The doctor will decide the correct dose of INOmax and will administer INOmax to the patient's lungs
through a system designed for this purpose. This system will ensure the administration of the correct
amount of nitric oxide by diluting INOmax with an oxygen/air mixture immediately before
administration.
For your safety and that of the child, the systems provided for the administration of INOmax
are equipped with devices that constantly measure the amount of nitric oxide, oxygen and
nitrogen dioxide (a chemical substance formed by mixing nitric oxide and oxygen)
delivered to the lungs.
The doctor will decide the duration of treatment with INOmax.
INOmax is administered in doses of 10 to 20 ppm (maximum dose of 20 ppm in children and 40 ppm in
adults), i.e. parts per million to be inhaled. The minimum effective dose will be identified. Therapy is
usually necessary for about 4 days in neonates with respiratory failure associated with
high blood pressure in the lungs. In children and adults with high pulmonary blood pressure, related to
cardiac surgery, INOmax is usually administered for

• 24 – 48 hours. However, therapy with INOmax may last longer.

If you or the child have taken more INOmax than you should
Excessive inhalation of nitric oxide can affect the blood's ability to carry
oxygen. This will be monitored through blood samples and, if necessary, the dose of INOmax will be
reduced; the administration of medications such as vitamin C
or methylene blue, or possibly a blood transfusion, may be considered in order to improve the ability to
carry oxygen in the blood.

If you stop the treatment with INOmax
Treatment with INOmax should not be stopped abruptly. It is known that if you stop the
treatment with INOmax suddenly without first reducing the dose, a decrease occurs
in blood pressure or a return of increased pulmonary pressure.
At the end of treatment, the doctor will slowly lower the amount of INOmax administered to you
or the child so that the circulation in the lungs can adjust to oxygen/air without INOmax.
Therefore, it may take a day or two before you or the child completely stop INOmax therapy.
If you have any doubts about the use of this medicine, please consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The doctor will carefully examine you or your child to check for the absence of any side effects.
The side effects observed very commonly (more than 1 in 10 patients) in relation to therapy with INOmax include:

• Low platelet count.

The side effects observed commonly (more than 1 in 100 patients)in relation to therapy with
INOmax include:

• Low blood pressure, collapsed or oxygen-deprived lung.

Side effects that can be observed, but are not common (between 1 in 100 and 1 in

• 1000)include:
• Increased levels of methemoglobin, with reduced oxygen carrying capacity.

Side effects that can be observed but with unknown frequency ( frequency cannot be estimated on the

basis of available data) are:

• Bradycardia (slow heart rate) or too low oxygen levels in the blood (oxygen desaturation/hypoxia) due to abrupt discontinuation of treatment.
• Headache, dizziness, dry throat or shortness of breath following accidental environmental exposure to nitric oxide (e.g. following a leak from the equipment or cylinder).

Immediately inform staff if a headache is detected when near the child undergoing INOmax therapy.
If any side effect gets worse, or if you notice any side effect not listed in this leaflet, even after your or the child’s discharge, inform the doctor.

Reporting of side effects
If you get any side effect, talk to your doctor. You can also report side effects directly through the national reporting system detailed in Appendix V.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store INOmax

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label preceded by the abbreviation
EXP. The expiry date refers to the last day of the month indicated.
Therapy with INOmax must be performed and managed exclusively by hospital personnel.

• INOmax cylinders must be stored securely to prevent them from falling and therefore the risk of potential injury.
• INOmax must be used and administered exclusively by personnel specifically trained in the use and handling of INOmax.

Observe all rules pertaining to the handling of pressurized cylinders.
Storage takes place under the supervision of specialists at the hospital. Store the gas cylinders in well-ventilated areas, or in ventilated sheds protected from rain and exposure to direct sunlight.

Protect gas cylinders from impacts, falls, oxidation and flammable materials, humidity, heat or ignition sources.

Storage in the pharmacy department
Store gas cylinders in a well-ventilated, clean and locked place, reserved exclusively for the storage of medicinal gases. Within this room, assign a separate area for the storage of nitrous oxide cylinders.

Storage in the medical department
Place the gas cylinder in an equipped site, with appropriate material to keep the cylinder in a vertical position.
When the cylinder is empty, do not dispose of it. Empty cylinders are collected by the supplier.

6. Contents of the pack and other information

What INOmax contains
The active ingredient of INOmax is nitric oxide 800 ppm mol/mol. A 2-liter cylinder filled
to a pressure of 155 bar absolute provides 307 liters of gas at a pressure of 1 bar at 15 °C.
A 10-liter cylinder filled to a pressure of 155 bar absolute provides 1535 liters of gas at a
pressure of 1 bar at 15 °C.
The excipient is nitrogen.

Description of the appearance of INOmax and contents of the pack
Compressed medicinal gas
A 2-liter aluminum gas cylinder (identification with an aquamarine-colored ogive and a white body), filled to a pressure of 155 bar and equipped with a positive (residual) pressure valve
made of stainless steel with a specific outlet connection and a standard valve knob.
A 2-liter aluminum gas cylinder (identification with an aquamarine-colored ogive and a white body), filled to a pressure of 155 bar and equipped with a positive (residual) pressure valve
made of stainless steel with a specific outlet connection and a valve knob equipped with an
INOmeter device.
A 10-liter aluminum gas cylinder (identification with an aquamarine-colored ogive and a white body), filled to a pressure of 155 bar and equipped with a positive (residual) pressure valve
made of stainless steel with a specific outlet connection and a standard valve knob.
A 10-liter aluminum gas cylinder (identification with an aquamarine-colored ogive and a white body), filled to a pressure of 155 bar and equipped with a positive (residual) pressure valve
made of stainless steel with a specific outlet connection and a valve knob equipped with an
INOmeter device.
INOmax is available in 2-liter and 10-liter aluminum cylinders.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Linde Healthcare AB
Rättarvägen 3
169 68 Solna
Sweden

Manufacturer
Linde France
Z.I. Limay-Porcheville
3 avenue Ozanne
78440 Porcheville
France
For further information on this medicine, contact the local representative of the marketing
authorization holder:

België/Belgique/Belgien
Linde Gas Belgium N.V.
Westvaartdijk 85
1850 Grimbergen
Tél/Tel.: +32 70 233 826
[email protected]

Lietuva
Linde Gas UAB
Didlaukio g. 69
08300, Vilnius
Tel.: +370 2787787
[email protected]

България
Linde Healthcare AB
Rättarvägen 3
169 68 Solna
Sweden
Tel: +46 8 7311000

Luxembourg/Luxemburg
Linde Gas Belgium N.V.
Westvaartdijk 85
1850 Grimbergen
Tél/Tel.: +32 70 233 826
[email protected]

Česká republika
Linde Gas a.s.
U Technoplynu 1324
198 00 Praha 9
Tel: +420 800 121 121
[email protected]

Magyarország
Linde Gáz Magyarország Zrt.
Illatos út 11/A.
1097 Budapest
Tel.: +36 30 349 2237
[email protected]

Danmark
Linde Gas A/S
Lautruphøj 2-6
2730 Ballerup
Tlf: + 45 70 104 103
[email protected]

Malta
Linde Healthcare AB
Rättarvägen 3
169 68 Solna
Sweden
Tel: +46 8 7311000

Deutschland
Linde GmbH
Dr.-Carl-von-Linde-Straße 6-14
82049 Pullach
Tel: +49 89 7446 0
[email protected]

Nederland
Linde Gas Therapeutics Benelux B.V.
De Keten 7
5651 GJ Eindhoven
Tel: +31 40 282 58 25
[email protected]

Eesti
AS Linde Gas
Valukoja 8
11415 Tallinn
Tel: +372 650 4500
[email protected]

Norge
Linde Gas AS
Postboks 13 Nydalen
0409 Oslo
Tlf. +47 81559095
[email protected]

Ελλάδα
ΛΙΝΤΕ ΕΛΛΑΣ ΜΟΝ ΕΠΕ
Θέση Τρύπιο Λιθάρι
19600 Μάνδρα Αττικής
Τηλ: +30 211-1045500-510
[email protected]

Österreich
Linde Healthcare
Linde Gas GmbH
Modecenterstr.17/ Objekt 1/3.OG
1110 Wien
Tel: +43(0)50.4273-2200
[email protected]

España
Linde Gas España, S.A.U.
Camino de Liria, s/n
46530 Puzol (Valencia)
Tel: +34 900 941 857 / +34 902 426 462
[email protected]

Polska
Linde Gaz Polska Sp. z o.o.
ul. prof. Michała Życzkowskiego 17
31-864 Krakow
Tel.: 0 801 142 748 / +48 (12) 643 92 00
[email protected]

Portugal
Linde Portugal, Lda.
Av. Infante D. Henrique Lotes 21-24
1800-217 Lisboa
Tel: + 351 218 310 420
linde.portugal@ linde.com

Hrvatska
GTG plin d.o.o.
Kalinovac 2/a
47000 Karlovac
Tel. +385 47 609 200

France
Linde France - Activité médicale - Linde
Healthcare
3 avenue Ozanne
Z.I. Limay-Porcheville
78440 Porcheville
Tél:+33 810 421 000
[email protected]

România
Linde Gaz România SRL
str. Avram Imbroane nr. 9
Timisoara 300136 - RO
Tel: +40 256 300 700
[email protected] [email protected]

Ireland
INO Therapeutics UK
185 Carver Drive
Kent Science Park
Sittingbourne
Kent ME9 8NP
Tel: +44 1795 411552
[email protected]

Slovenija
GTG plin d.o.o.
Bukovžlak 65/b
3000 CELJE
Tel: + 386 (0)3 42 60 746
[email protected]

Ísland
Linde Gas ehf
Breiðhöfða 11
110 Reykjavik
Sími: + 354 577 3030
[email protected]

Slovenská republika
Linde Gas s.r.o.
Tuhovská 3
831 06 Bratislava
Tel: +421 2 49 10 25 16
[email protected]

Suomi/Finland
Oy Linde Gas Ab
Itsehallintokuja 6
02600 Espoo
Puh/Tel: + 358 10 2421
[email protected]

Κύπρος
Linde Hadjikyriakos Gas Ltd
Λεωφόρος Λεμεσού 260, 2029 Στρόβολος
Λευκωσία, Κύπρος.
Τηλ. +357-22482330
[email protected]

Italia
LINDE MEDICALE S.r.L
Via Guido Rossa 3
20010 Arluno (MI)
Tel : +39 02 903731 / 800 600 633

Sverige
Linde Gas AB
Rättarvägen 3
169 68 Solna
Tel: + 46 8 7311800
[email protected]

Latvija
Linde Gas SIA,
Katrīnas iela 5
Rīga, 1045
Tel: +371 80005005
[email protected]

United Kingdom
INO Therapeutics UK
185 Carver Drive
Kent Science Park
Sittingbourne
Kent ME9 8NP
Tel: +44 1795 411552
[email protected]

This leaflet was updated on MM/YYYY.
Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.