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NEOPHYR 1000 PPM MOL/MOL COMPRESSED MEDICAL GAS

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About the medicine

How to use NEOPHYR 1000 PPM MOL/MOL COMPRESSED MEDICAL GAS

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the User

Neophyr 225 ppm mol/mol, medicinal compressed gas

Neophyr 450 ppm mol/mol, medicinal compressed gas

Neophyr 1000 ppm mol/mol, medicinal compressed gas

Nitric oxide

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Neophyr and what is it used for

Neophyr is a gas mixture for inhalation use.

Neophyr is a medicinal compressed gas consisting of a gas mixture containing 225 ppm, 450 ppm or 1000 ppm mol/mol of nitric oxide.

What is it used for?

Neophyr should be administered exclusively by healthcare professionals and is intended for strictly hospital use.

Neophyr is indicated in the following cases:

  • Newborn babies with pulmonary insufficiency associated with high blood pressure in the lungs, a health problem known as hypoxic respiratory failure. By inhaling it, the gas mixture can improve blood flow within the lungs, which can contribute to increasing the amount of oxygen that reaches the baby's blood.
  • Newborn babies, babies, children, and adolescents from 0 to 17 years and adults with high blood pressure in the lungs related to heart surgery. This gas mixture can improve heart function and increase blood flow within the lungs.
Doctor consultation

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Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you use Neophyr

Do not use Neophyr:

  • If you are allergic to nitric oxide or any of the other components of this medicine (listed in section 6).
  • If you have been told that you (as a patient) or your child (as a patient) have abnormal circulation in the heart.
  • If you (as a patient) or your child (as a patient) have a congenital or acquired deficiency of methemoglobin reductase (MetHb reductase) or glucose-6-phosphate dehydrogenase (G6PD).

Warnings and precautions

Consult your doctor before starting to use Neophyr.

Inhaled nitric oxide may not be effective in all cases, so other therapies may be considered necessary for you or your child.

Inhaled nitric oxide can affect the blood's ability to transport oxygen. This function will be monitored through blood sampling, 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 respiratory tract. The doctor treating you or your child will monitor the nitrogen dioxide levels and, if high values are detected, will adjust the Neophyr therapy or reduce it as necessary.

Inhaled nitric oxide can mildly affect the platelets (components that contribute to blood clotting) in your body or that of your child, so the appearance of any signs of bleeding and/or bruising should be supervised. If you notice any signs or symptoms that may be associated with bleeding, you should inform your doctor directly.

No effects of inhaled nitric oxide have been documented in newborn babies with a malformation that means the diaphragm is not fully present (also called "congenital diaphragmatic hernia").

In newborn babies with special heart malformations, what doctors call "congenital heart disease", inhaled nitric oxide can cause a worsening of circulation.

Cases of fluid retention in the lungs have been reported with the use of nitric oxide in patients with disease caused by a blocked or narrow vein in the lungs. If you (as a patient) or your child (as a patient) develop shortness of breath or difficulty breathing, contact your doctor immediately.

Children

Neophyr should not be used in premature babies with a gestational age of less than 34 weeks.

Using Neophyr with other medicines

Your doctor will decide when to treat you or your child with Neophyr and other medicines, as well as carefully monitor the treatment.

Tell your doctor if you (as a patient) or your child (as a patient) are taking, have recently taken, or may need to take any other medicine.

Some medicines can affect the blood's ability to transport oxygen. These include prilocaine (a local anesthetic used to relieve pain in minor painful procedures, such as suturing and minor surgical or diagnostic procedures) or glyceryl trinitrate (used to treat chest pain). Your doctor will check that the blood can transport enough oxygen while you are using these medicines.

Pregnancy, breastfeeding, and fertility

Neophyr should not be used during pregnancy unless clearly necessary, such as in situations where life-support equipment is required.

Exposure to nitric oxide should be avoided in humans during breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

3. How to use Neophyr

Your doctor will decide on the correct dose of Neophyr and administer Neophyr to you or your child in the lungs through a system designed for the administration of this gas. This system will ensure the administration of the correct amount of nitric oxide by diluting Neophyr with an oxygen/air mixture immediately before administering it to the patient.

For your safety (or that of your child), the systems designed for Neophyr administration are equipped with devices that constantly measure the amount of nitric oxide, oxygen, and nitrogen dioxide (a chemical substance that forms when nitric oxide is mixed with oxygen) administered to the lungs.

Your doctor will decide how long the treatment with Neophyr should last for you or your child.

The recommended dose of Neophyr is 10 to 20 ppm (with a maximum dose for children of 20 ppm and for adults of 40 ppm) parts per million of the gas that you or your child inhale. The lowest effective dose will be used.

Therapy is usually required for about 4 days in newborn babies with pulmonary insufficiency associated with high blood pressure in the lungs. In children and adults with high blood pressure in the lungs associated with heart surgery, Neophyr is usually administered for 24-48 hours. However, Neophyr therapy may last longer.

If you use more Neophyr than you should

Excessive inhalation of nitric oxide can affect the blood's ability to transport oxygen. This function will be monitored through blood sampling, and if necessary, the dose of Neophyr will be reduced, and the administration of medicines such as vitamin C, methylene blue, or, if necessary, a blood transfusion, will be considered to improve the blood's oxygen transport capacity.

If you stop using Neophyr

Treatment with Neophyr should not be stopped suddenly. It has been observed that low blood pressure or a rebound effect of increased pressure in the lungs occurs if Neophyr treatment is stopped suddenly without first reducing the dose.

At the end of treatment, your doctor will gradually reduce the amount of Neophyr prescribed for you or your child, so that lung circulation can adjust to the amount of oxygen/air without Neophyr. Consequently, this may take one or two days before you or your child finish treatment with Neophyr.

Follow your doctor's instructions for administering this medicine exactly. If you are in doubt, ask your doctor, pharmacist, or nurse.

Medicine questions

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Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Your doctor will closely monitor and supervise any type of side effect. It is unlikely that you will suffer from these side effects.

The side effects that occur very frequently (affect more than 1 in 10 patients) associated with Neophyr therapy include:

  • Low platelet count, abnormally low potassium concentration in the blood (hypokalemia), low blood pressure, shortness of breath or lung collapse, abnormally high levels of bilirubin in the blood.

The side effects that may occur, but whose frequency is not known (cannot be estimated from the available data) are:

  • Rebound effect of high blood pressure in the lungs (increase in pulmonary arterial pressure) and low oxygen levels in the blood (oxygen desaturation/hypoxemia) due to sudden withdrawal of treatment; increased methemoglobin and, therefore, decreased oxygen transport capacity.
  • Accidental exposure of nitric oxide to the ambient air, e.g., due to equipment or cylinder leakage, may cause headache.

You should inform the staff directly if you experience a headache while you are near your child when Neophyr is being administered.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, tell your doctor.

If you have any further questions on the use of this product, ask your doctor or other healthcare professionals.

Reporting side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) online system: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Neophyr

Keep this medicine out of the sight and reach of children.

Neophyr therapy should only be used and handled by hospital personnel.

  • Neophyr cylinders should be stored in a way that they are secured so that they cannot fall or cause potential damage.
  • Neophyr should be used and administered exclusively by personnel specially trained in the use and handling of this product.

All regulations regarding the handling of pressure cylinders must be respected.

Storage will be supervised by specialists in the hospital. Gas cylinders should be stored in well-ventilated rooms or sheds where they are protected from rain and direct sunlight.

Cylinders should be stored at a temperature between -10 and +50 °C.

Protect the cylinders from shocks, falls, oxidizing or flammable materials, moisture, and heat or ignition sources.

Storage in the pharmacy department

Gas cylinders should be kept in a designated area exclusively for the storage of medicinal gases that is well-ventilated, clean, and locked. This area should have a special separate installation for the storage of nitric oxide gas cylinders.

Storage in the medical department

The gas cylinder should be placed in an area where there are suitable equipment to ensure that the cylinder remains in a vertical position.

When the cylinder is empty, it should not be disposed of with other waste: the supplier will collect the empty cylinders.

Do not use this medicine after the expiry date which is stated on the gas cylinder label, after EXP. The expiry date is the last day of the month shown.

6. Contents of the pack and other information

Composition of Neophyr

  • The active substance is nitric oxide 225 ppm mol/mol, 450 ppm mol/mol, or 1000 ppm mol/mol.
  • The other component is nitrogen.

Appearance and pack contents

Gas cylinders with a capacity of 2 l (Neophyr 1000 ppm mol/mol).

A 2-liter gas cylinder filled to 150 bar contains approximately 0.35 kg of gas.

or

Gas cylinders with a capacity of 10 l (Neophyr 225 ppm mol/mol, Neophyr 450 ppm mol/mol, Neophyr 1000 ppm mol/mol).

A 10-liter gas cylinder filled to 150 bar contains approximately 1.77 kg of gas.

The cylinders made of an aluminum alloy have a white-painted body and a turquoise-painted tip.

They are equipped with a stainless steel residual pressure valve with a specific ISO 5145 (2004) type outlet connector.

Marketing authorization holder and manufacturer

Marketing authorization holder

SOL FRANCE SUCURSAL EN ESPAÑA

Calle Yeso, num. 2

28500 Arganda del Rey - (Madrid) Spain

Manufacturer

SOL S.p.A.

Via Libertà 247

20900 Monza

Italy

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Neophyr

Austria: Neophyr

Belgium: Neophyr

Bulgaria: Neophyr

Cyprus: Neophyr

Croatia: Neophyr

Slovenia: Neophyr

Spain: Neophyr

Greece: Neophyr

Ireland: Neophyr

Italy: Neophyr

Luxembourg: Neophyr

Netherlands: Neophyr

Romania: Neophyr

United Kingdom: Neophyr

Czech Republic: Iasophyr

Hungary: Noxphyr

Slovakia: Neophyr

Date of last revision of this leaflet: May 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS): http://www.aemps.gob.es//

The following information is intended exclusively for healthcare professionals.

[The complete summary of product characteristics will be included below].

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Discuss questions about NEOPHYR 1000 PPM MOL/MOL COMPRESSED MEDICAL GAS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Tarek Agami

General medicine 11 years exp.

Dr. Tarek Agami is a general practitioner registered in both Portugal and Israel, with broad experience in family and preventive medicine. He offers online consultations for adults and children, providing personalised support for primary care needs, chronic disease management, and everyday health concerns.

Dr. Agami received clinical training and worked in leading medical institutions in Israel (Kaplan Medical Center, Barzilai Medical Center, Wolfson Medical Center) and Portugal (European Healthcare City, Viscura Internacional, Hospital Dr. José Maria Grande, Hospital Vila Franca de Xira). His approach combines international medical standards with individualised attention to each patient.

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  • Medical support during travel or after relocation
  • Treatment adjustments and lifestyle recommendations based on your personal history
Dr. Agami provides medical support for patients using GLP-1 medications (such as Ozempic or Mounjaro) as part of a weight loss strategy. He offers individualised treatment planning, regular follow-up, dose adjustment, and advice on combining medication with sustainable lifestyle changes. Consultations follow the medical standards accepted in Portugal and Israel.

Dr. Agami is committed to evidence-based, patient-centred care, ensuring that each person receives trusted medical support tailored to their health goals.

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Nuno Tavares Lopes

Family medicine 18 years exp.

Dr. Nuno Tavares Lopes is a licensed physician in Portugal with 17 years of experience in emergency medicine, family and general practice, and public health. He is the Director of Medical and Public Health Services at an international healthcare network and serves as an external consultant for the WHO and ECDC.

  • Emergency care: infections, fever, chest/abdominal pain, minor injuries, paediatric emergencies
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Dr. Nuno Tavares Lopes provides medical support for patients using GLP-1 medications (Mounjaro, Wegovy, Ozempic, Rybelsus) as part of a weight loss strategy. He offers individualised treatment planning, regular follow-up, dose adjustment, and advice on combining medication with sustainable lifestyle changes. Consultations follow the medical standards accepted in Europe.

Dr. Lopes also provides interpretation of medical tests, follow-up care for complex patients, and multilingual support. Whether for urgent concerns or long-term care, he helps patients act with clarity and confidence.

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Anastasiia Shalko

Family medicine 13 years exp.

Dr. Anastasiia Shalko is a general practitioner with a background in both paediatrics and general medicine. She graduated from Bogomolets National Medical University in Kyiv and completed her paediatric internship at the P.L. Shupyk National Medical Academy of Postgraduate Education. After working as a paediatrician in Kyiv, she relocated to Spain, where she has been practising general medicine since 2015, providing care for both adults and children.

Her work focuses on urgent, short-term medical concerns – situations where patients need quick guidance, symptom assessment and clear next steps. She helps people understand whether their symptoms require in-person evaluation, home management or a change in treatment. Common reasons for booking an online consultation include:

  • acute respiratory symptoms (cough, sore throat, runny nose, fever)
  • viral illnesses such as colds and seasonal infections
  • gastrointestinal complaints (nausea, diarrhoea, abdominal pain, gastroenteritis)
  • sudden changes in how a child or adult feels
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Dr. Shalko works specifically with urgent and short-term problems, providing practical recommendations and helping patients determine the safest next step. She explains symptoms clearly, guides patients through decision-making and offers straightforward medical advice for everyday acute issues.

She does not provide long-term management of chronic conditions, ongoing follow-up or comprehensive care plans for complex long-term illnesses. Her consultations are designed for acute symptoms, sudden concerns and situations where timely medical input is important.

With clinical experience in both paediatrics and general medicine, Dr. Shalko confidently supports adults and children. Her communication style is clear, simple and reassuring, helping patients feel informed and supported throughout the consultation.

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Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques.

For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance.

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In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions.

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Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.
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Daniel Cichi

Family medicine 24 years exp.

Dr Daniel Cichi is a family medicine doctor with over 20 years of clinical experience. He provides online consultations for adults, supporting patients with acute symptoms, chronic conditions, and everyday health concerns that require timely medical guidance.

His background includes work in emergency care, ambulance services, and family medicine, which allows him to assess symptoms quickly, identify warning signs, and help patients choose the safest next steps – whether that means home care, treatment adjustment, or in-person evaluation.

Patients commonly consult Dr Daniel Cichi for:

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Frequently Asked Questions

Is a prescription required for NEOPHYR 1000 PPM MOL/MOL COMPRESSED MEDICAL GAS?
NEOPHYR 1000 PPM MOL/MOL COMPRESSED MEDICAL GAS requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in NEOPHYR 1000 PPM MOL/MOL COMPRESSED MEDICAL GAS?
The active ingredient in NEOPHYR 1000 PPM MOL/MOL COMPRESSED MEDICAL GAS is nitric oxide. This information helps identify medicines with the same composition but different brand names.
Who manufactures NEOPHYR 1000 PPM MOL/MOL COMPRESSED MEDICAL GAS?
NEOPHYR 1000 PPM MOL/MOL COMPRESSED MEDICAL GAS is manufactured by Sol France Sucursal En Espana. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of NEOPHYR 1000 PPM MOL/MOL COMPRESSED MEDICAL GAS online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether NEOPHYR 1000 PPM MOL/MOL COMPRESSED MEDICAL GAS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to NEOPHYR 1000 PPM MOL/MOL COMPRESSED MEDICAL GAS?
Other medicines with the same active substance (nitric oxide) include INOMAX 400 PPM MOL, COMPRESSED MEDICAL GAS, INOMAX 400 PPM MOL, COMPRESSED MEDICAL GAS, INOMAX 800 PPM MOL/MOL, COMPRESSED MEDICAL GAS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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