Patient leaflet - INOmax
1. What INOmax is and what it is used for
INOmax contains nitric oxide, a gas used for the treatment of
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■ newborn babies with lung failure associated with high blood pressure in the lungs, a condition known as hypoxic respiratory failure. When inhaled, this gas mixture can improve the flow of blood through the lungs, which may help to increase the amount of oxygen that reaches your baby’s blood.
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■ newborn babies, babies, children, teenagers 0–17 years and adults with high blood pressure in the lungs, connected with heart surgery. This gas mixture can improve heart function and increase the flow of blood through the lungs, which may help to increase the amount of oxygen that reaches the blood.
2. What you need to know before you begin a treatment with INOmax
Do not use INOmax
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– If you (as the patient) or your child (as the patient) are allergic (hypersensitive) to nitric oxide or any other ingredients of INOmax. (see section 6 ‘further information’ where the full list of ingredients is provided).
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– If you have been told that you (as the patient) or your child (as the patient) have an abnormal
circulation within the heart.
Warnings and precautions
Inhaled nitric oxide may not always be effective and thus other therapies may be considered necessary for you or your child.
Inhaled nitric oxide may influence the oxygen carrying capacity of the blood. This will be monitored by blood samples and if required the dose of inhaled nitric oxide must be reduced.
Nitric oxide may react with oxygen forming nitrogen dioxide that may cause airway irritation. Your or your child’s doctor will undertake monitoring of nitrogen dioxide and in case of elevated values the INOmax therapy will be adjusted, decreased accordingly.
Inhaled nitric oxide may have a mild but influence on the platelets (components that help the blood to clot) of you or your child and any signs of bleeding and or haematoma should be observed. If you see any signs or symptoms that may be associated to bleeding you should directly inform the doctor.
No effect of inhaled nitric oxide has been documented in newborn babies with a malformation where the diaphragm is not fully complete, so called ‘congenital diaphragmatic hernia’.
In newborn babies with special malformations of the heart, ‘what doctors calls congenital heart defects’ inhaled nitric oxide may cause a worsening of the circulation.
Children
INOmax should not be used in preterm baby < 34 weeks of gestational age.
Other medicines and INOmax
The doctor will decide when to treat you or your child with INOmax and with other medicines, and will carefully supervise the treatment.
Please tell your doctor if you (as the patient) or your child (as the patient) are taking or have recently taken or used any other medicines, including medicines obtained without a prescription.
Some medicines can affect the ability of blood to carry oxygen. These include prilocaine (a local anaesthetic used for pain relief in association to minor painful procedures e.g. suturing, and minor surgical or diagnostic procedures) or glyceryl trinitrate (used to treat chest pain). Your doctor will take care to check that the blood can carry enough oxygen when you are taking these medicines.
Pregnancy and breastfeeding
INOmax is not recommended for use during pregnancy and breastfeeding.
Tell your doctor before treatment with INOmax if you are pregnant, think you could be pregnant or are breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Not relevant.
INOmax contains Nitrogen
3. How to use INOmax
Your doctor will decide the correct dose of INOmax and will administer INOmax to you or your child’s lungs through a system designed for delivering this gas. This delivery system will ensure that the correct amount of nitric oxide is delivered by diluting INOmax with an oxygen/air mixture immediately before giving it to you.
For you or your child’s safety, the delivery systems intended for administration of INOmax are fitted with devices that constantly measure the amount of nitric oxide, oxygen and nitrogen dioxide (a chemical formed when nitric oxide and oxygen are mixed) being delivered to the lungs.
Your doctor will decide how long you or your child should be treated with INOmax.
INOmax is given in dose of 10 to 20 ppm, (maximal dose 20 ppm in children and 40 ppm in adults) part per million of the gas that you or your child inhale. The lowest effective dose will be sought. Therapy is usually required for about 4 days in newborn infants with lung failure associated with high blood pressure in the lungs. In children and adults with high blood pressure in the lungs, connected with heart surgery, INOmax is usually given for 24–48 hours. However, therapy with INOmax may last longer.
If you or your child receive more INOmax than you should
Too much of inhaled nitric oxide may influence the oxygen carrying capacity of the blood. This will be monitored by blood samples and if required the INOmax dose will be decreased and the administration of medicines such as vitamin C, methylene blue, or eventually blood transfusion, in order to improve the oxygen carrying capacity, may be considered.
If you stop using INOmax
Treatment with INOmax should not be stopped suddenly. Low blood pressure or a rebound increase in pressure in the lungs has been known to occur if treatment with INOmax is stopped suddenly without first lowering the dose.
At the end of treatment, the doctor will slowly lower the amount of INOmax being given to you or your child, so that the circulation in the lungs is able to adjust to oxygen/air without INOmax. Thus it may take a day or two before you or your child is off INOmax therapy.
If you have any other questions on the use of this medicine, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The doctor will examine you or your child closely for all side effects.
Side effects that are very commonly seen (affects more than 1 user in 10) in association with INOmax therapy include:
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■ Low platelet count.
Side effects that are commonly seen (affects more than 1 user in 100) in association with INOmax therapy include:
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■ low blood pressure, airless or collapsed lung.
Side effects that may be seen, but uncommonly (affects between 1 user in 100 and 1 user in 1000) are: ■ increase in methaemoglobin, thus reduced oxygen carrying capacity.
Side effects that may be seen but the frequency is not known (frequency cannot be estimated from the available data) are:
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■ Bradycardia (low cardiac frequency) or too low amount of oxygen in the blood (oxygen
desaturation/hypoxemia) due to sudden withdrawal of the treatment,
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■ Headache, dizziness, dry throat or shortness of breath following accidental ambient air exposure
to nitric oxide (e.g. leakage from equipment or cylinder).
You should directly inform the personnel if you experience headache while being in close proximity to your child receiving INOmax.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, even after you or your child leave the hospital, please tell your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed inBy 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 after EXP. The expiry date refers to the last day of that month.
INOmax therapy should only be used and handled by hospital personnel.
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■ INOmax cylinders should be stored secured in order to avoid falling and thus potentially causing harm.
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■ INOmax should be used and administered only by personnel specially trained in the use and handling of INOmax.
6. Contents of the pack and other information
What INOmax contains
The active substance in INOmax is nitric oxide 400 ppm mol/mol. A 2 litre gas cylinder filled at 155 bar absolute brings 307 litres of gas under pressure of 1 bar at 15oC. A 10 litre gas cylinder filled at 155 bar absolute brings 1535 litres of gas under pressure of 1 bar at 15oC.
The other ingredient is nitrogen.
What INOmax looks like and contents of the pack
Medicinal gas, compressed
A 2 litre aluminium gas cylinder (identification with aquamarine shoulder and white body) filled under a pressure of 155 bar, equipped with a stainless steel positive pressure (residual) valve with a specific outlet connection and a standard valve hand-wheel.
A 2 litre aluminium gas cylinder (identification with aquamarine shoulder and white body) filled under a pressure of 155 bar, equipped with a stainless steel positive pressure (residual) valve with a specific outlet connection and a INOmeter device equipped valve hand-wheel.
A 10 litre aluminium gas cylinder (identification with aquamarine shoulder and white body) filled under a pressure of 155 bar, equipped with a stainless steel positive pressure (residual) valve with a specific outlet connection and a standard valve hand-wheel.
A 10 litre aluminium gas cylinder (identification with aquamarine shoulder and white body) filled under a pressure of 155 bar, equipped with a stainless steel positive pressure (residual) valve with a specific outlet connection and a INOmeter device equipped valve hand-wheel.
INOmax is available in 2 litre and 10 litre aluminium gas cylinder.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Linde Healthcare AB
Rättarvägen 3
169 68 Solna
Sweden
Manufacturer
Linde France
Z.I. Limay Porcheville
3 avenue Ozanne
78440 Porcheville
France
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
| België/Belgique/Belgien Linde Gas Belgium N.V. Westvaartdijk 85 1850 Grimbergen Tél/Tel.: +32 70 233 826 | Lietuva Linde Gas UAB Didlaukio g. 69 08300, Vilnius Tel.: +370 2787787 |
| Efc^rapufl Linde Healthcare AB Râttarvâgen 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 |
| Česká republika Linde Gas a.s. U Technoplynu 1324 198 00 Praha 9 Tel: +420 800 121 121 | Magyarország Linde Gáz Magyarország Zrt. Illatos út 11/A. 1097 Budapest Tel.: +36 30 349 2237 |
| Danmark Linde Gas A/S | Malta Linde Healthcare AB |
Lautruph0j 2–6
2730 Ballerup
Tlf: + 45 70 104 103
Deutschland
Linde GmbH
Dr.-Carl-von-Linde-Straße 6–14 82049 Pullach
Tel: +49 89 7446 0
Eesti
AS Linde Gas
Valukoja 8 11415 Tallinn
Tel: +372 650 4500
EZZäöa
AINTE EAAAZ MON EnE
©son Tpi'inio Ai0api 19600 MavSpa Attik^ Tql: +30 211–1045500–510
España
Linde Gas España, S.A.U.
Camino de Liria, s/n
46530 Puzol (Valencia)
Tel: +34 900 941 857 / +34 902 426 462
France
Linde France – Activité médicale – Linde Healthcare
3 avenue Ozanne
Z.I. Limay-Porcheville
78440 Porcheville
Tél:+33 810 421 000
Hrvatska
GTG plin d.o.o.
Kalinovac 2/a
47000 Karlovac
Tel. +385 47 609 200
Ireland
INO Therapeutics UK
185 Carver Drive
Kent Science Park
Sittingbourne
Kent ME9 8NP
Tel: +44 1795 411552
Rättarvägen 3
169 68 Solna
Sweden
Tel: +46 8 7311000
Nederland
Linde Gas Therapeutics Benelux B.V.
De Keten 7
5651 GJ Eindhoven
Tel: +31 40 282 58 25
Norge
Linde Gas AS
Postboks 13 Nydalen
0409 Oslo
Tlf. +47 81559095
Österreich
Linde Healthcare
Linde Gas GmbH
Modecenterstr.17/ Objekt 1/3.OG
1110 Wien
Tel: +43(0)50.4273–2200
Polska
Linde Gaz Polska Sp. z o.o.
ul. prof. Michala Zyczkowskiego 17
31–864 Krakow
Tel.: 0 801 142 748 / +48 (12) 643 92 00
Portugal
Linde Portugal, Lda.
Av. Infante D. Henrique Lotes 21–24
1800–217 Lisboa
Tel: + 351 218 310 420
linde.portugal@ linde.com
Romania
Linde Gaz Romania SRL str. Avram Imbroane nr. 9 Timisoara 300136 – RO Tel: +40 256 300 700
Slovenija
GTG plin d.o.o.
Bukovzlak 65/b 3000 CELJE
Tel: + 386 (0)3 42 60 746
| Island Linde Gas ehf Breidhofda 11 110 Reykjavik Simi: + 354 577 3030 | Slovenská republika Linde Gas s.r.o. Tuhovská 3 831 06 Bratislava Tel: +421 2 49 10 25 16 |
| 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 |
| Knnpog Linde Hadjikyriakos Gas Ltd Asopopog Asp.soou 260, 2029 ETpoPoXog AsuKOJoia, Kunpog. Tip.. +357–22482330 | Sverige Linde Gas AB Rattarvagen 3 169 68 Solna Tel: + 46 8 7311800 |
| Latvija Linde Gas SIA, Katrinas iela 5 Riga, 1045 Tel: +371 80005005 | United Kingdom INO Therapeutics UK 185 Carver Drive Kent Science Park Sittingbourne Kent ME9 8NP Tel: +44 1795 411552 |
This leaflet was last revised in MM/YYYY.
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site:.