Інструкція із застосування NEOPYR
Зміст інструкції
Neophyr 225 ppm mol/mol medicinal gas, compressed, 450 ppm mol/mol medicinal gas, compressed, 1000 ppm mol/mol medicinal gas, compressed
Nitrous oxide 225 ppm, 450 ppm, 1000 ppm mol/mol
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.
- This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor. See section 4.
Contents of this leaflet:
- 1. What Neophyr is and what it is used for
- 2. What you need to know before using Neophyr
- 3. How to use Neophyr
- 4. Possible side effects
- 5. How to store 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 gas, compressed, consisting of a gas mixture containing 225 ppm,
450 ppm or 1000 ppm mol/mol of nitrous oxide.
What are its uses?
Neophyr must be administered exclusively by healthcare professionals and is strictly for
hospital use.
Neophyr is indicated in the following conditions:
- newborns affected by pulmonary insufficiency associated with high blood pressure in the lungs, a condition known as hypoxic respiratory failure. When inhaled, this gas mixture can improve blood flow through the lungs, increasing the amount of oxygen that reaches the baby's blood.
- newborns, infants, children, adolescents aged between 0 and 17 years and adults with high blood pressure in the lungs, related to cardiac surgery. This gas mixture can improve cardiac function and increase blood flow to the lungs.
2. WHAT YOU NEED TO KNOW BEFORE USING NEOPHYR
Do not use Neophyr:
- If you (as a patient) or the child (as a patient) are allergic (hypersensitive) to nitrous oxide or any of the other ingredients of this medicine (listed in section 6).
- If you (as a patient) or the child (as a patient) have been diagnosed with abnormal blood flow within the heart.
- If you (as a patient) or the 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 using Neophyr.
Nitrous oxide inhalation may not always be effective and therefore other therapies may
be necessary for you or the child.
Nitrous oxide inhalation can alter the blood's ability to transport oxygen. This
effect will be monitored with blood samples and, if necessary, the dose of nitrous oxide for
inhalation will need to be reduced.
Nitrous 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, therapy with Neophyr will be adjusted and reduced accordingly.
Nitrous oxide inhalation 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 should be monitored. If signs or symptoms are detected that
may be associated with bleeding, you should immediately inform the doctor.
No effect of nitrous oxide inhalation has been documented in neonates with
malformations due to an incomplete diaphragm, the so-called “congenital diaphragmatic hernias”.
In neonates with particular heart malformations, those that doctors call “congenital heart
defects”, nitrous oxide inhalation can cause a worsening of circulation.
Children
Neophyr should not be administered to premature babies with less than 34 weeks of
gestation.
Other medicines and Neophyr
The doctor will decide when to treat you or the child with Neophyr and with other medicines, under close
supervision of the treatment.
Tell your doctor if you (as a patient) or the child (as a patient) are taking, have
recently taken or might take any other medicines.
Some medicines can affect the blood's ability to carry oxygen. These
include prilocaine (a local anesthetic used to relieve pain from minor procedures,
such as sutures, and minor diagnostic or surgical procedures) or glyceryl trinitrate (used
to treat chest pain). The doctor will check that the blood can carry enough oxygen
during the intake of these drugs.
Pregnancy, breastfeeding and fertility
Neophyr should not be used during pregnancy unless clearly necessary, such as in
life-support situations.
Exposure to nitrous oxide should be avoided in breastfeeding women.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor for advice before taking this medicine.
3. HOW TO USE NEOPHYR
The doctor will decide the correct dose of Neophyr and will administer Neophyr into your lungs or those
of your child through a system designed to release this gas. This system will ensure the
administration of the correct amount of nitric oxide by diluting Neophyr with a mixture of
oxygen/air immediately before administration.
For your safety or that of the child, the systems designed for the administration of Neophyr
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 Neophyr.
Neophyr 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 of gas that you or your child will inhale. The
minimum effective dose will be identified.
Therapy is usually necessary for about 4 days in newborns with respiratory failure
associated with high blood pressure in the lungs. In children and adults with high
pulmonary blood pressure, related to cardiac surgery, Neophyr is usually
administered for 24 – 48 hours. However, therapy with Neophyr may last longer.
If you receive more Neophyr than you should
Excessive inhalation of nitric oxide can affect the blood's ability to carry
oxygen. This will be monitored via blood samples and if necessary the dose of Neophyr 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 Neophyr
Treatment with Neophyr should not be stopped abruptly. It is known that if you stop
treatment with Neophyr suddenly without first reducing the dose, a
decrease in blood pressure or an increase in reboundpulmonary pressure occurs.
At the end of treatment, the doctor will slowly lower the amount of Neophyr administered to
you or the child so that the circulation in the lungs can get used to oxygen/air without
Neophyr. Therefore, it may take a day or two before you or the child stop
therapy with Neophyr completely.
If you have any questions about the use of this medicine, ask your doctor or other healthcare
professional.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everyone gets them.
The doctor will carefully detect and examine any side effect. It is unlikely that these
side effects will occur.
Very common side effects (affecting more than 1 in 10 patients)in
relation to therapy with Neophyr include:
- low number of platelets, unusual lowering of potassium concentration in the blood (hypokalaemia), low blood pressure, hypoxic or collapsed lung, unusually high amount of bile pigment (bilirubin) in the blood.
Side effects that have been observed but with unknown frequency (frequency cannot be defined
based on available data) are:
- rebound increase in pulmonary pressure (increased pressure in the pulmonary artery) and too low oxygen levels in the blood (oxygen desaturation/hypoxia) due to sudden discontinuation of treatment, increased methemoglobin and therefore reduced oxygen carrying capacity.
- Accidental exposure to environmental nitrogen oxide, for example following a leak from equipment or the cylinder, can cause headache.
You should immediately inform staff if you experience headache when near the child undergoing therapy with Neophyr.
If any of these side effects get worse or if you notice any side effect
If you have any doubts about using this medicine, ask your doctor or other
healthcare professional.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor. You can also report side effects directly through the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the
safety of this medicine.
5. HOW TO STORE NEOPHYR
Keep this medicine out of the sight and reach of children.
Therapy with Neophyr must be carried out and managed only by hospital personnel.
- Neophyr cylinders must be stored securely to prevent them from falling and therefore the potential risk of injury.
- Neophyr must be used and administered exclusively by personnel specifically trained in the use and handling of Neophyr.
All rules pertaining to the handling of pressurized cylinders must be observed.
Storage at the hospital is supervised by specialists. The cylinders must be
stored in well-ventilated indoor environments, or outdoors, in ventilated sheds protected from
rain and exposure to direct sunlight.
Cylinders must be stored at a temperature between -10 and +50°C.
Protect cylinders from impacts, falls, oxidizing and flammable materials, humidity, sources of
heat or ignition.
Storage in the pharmacy department
Cylinders must be stored in a well-ventilated, clean and locked place,
reserved exclusively for the storage of medicinal gases. Within this room, a separate area must be
assigned for the storage of nitrous oxide cylinders.
Storage in the medical department
The cylinder must be stored in a specially equipped place to keep the cylinder
upright.
Do not dispose of empty cylinders. Empty cylinders will be collected by the supplier.
Do not use this medicine after the expiry date indicated on the cylinder label. The expiry date refers to the last day of that month.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What Neophyr contains
- The active ingredient is nitric oxide 225 ppm mol/mol, 450 ppm mol/mol or 1000 ppm mol/mol
- The other component is nitrogen
Description of the appearance of Neophyr and contents of the pack
Cylinders with a capacity of 2 l (Neophyr 1000 ppm mol/mol).
One 2-liter cylinder filled to 150 bar contains approximately 0.35 kg of gas.
Cylinders with a capacity of 10 l (Neophyr 225 ppm mol/mol, Neophyr 450 ppm mol/mol, Neophyr
1000 ppm mol/mol ).
One 10-liter cylinder filled to 150 bar contains approximately 1.77 kg of gas.
The aluminum alloy cylinders have a white body and a turquoise-colored cap.
They are equipped with a residual pressure valve in stainless steel with a specific outlet connector of
ISO 5145 (2004) type.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
SOL S.p.A.
Via Borgazzi 27
20900 Monza
Italy
Manufacturer
SOL S.p.A:
Via Libertà 247
20900 Monza
Italy
This medicinal product is authorised in the Member States of the European Economic Area with the
following names:
Austria: Neophyr
Belgium: Neophyr
Bulgaria: Neophyr
Croatia: Neophyr
Cyprus: Neophyr
Germany: Neophyr
Greece: Neophyr
Ireland: Neophyr
Italy: Neophyr
Luxembourg: Neophyr
Netherlands: Neophyr
Romania: Neophyr
Slovenia: Neophyr
Spain: Neophyr
United Kingdom: Neophyr
The following information is intended only for healthcare professionals.
SUMMARY OF PRODUCT CHARACTERISTICS
- Країна реєстрації
- Лікарська формаInhalation gas, 225 PPM
- Код АТХR07AX01
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до NEOPYRЛікарська форма: Compressed medical gas, 400 PPMДіюча речовина: Оксид азота (II)Потрібен рецептЛікарська форма: Inhalation gas, 400 PPMДіюча речовина: Оксид азота (II)Виробник: LINDE HEALTHCARE ABПотрібен рецептЛікарська форма: Inhalation gas, 200 PPMДіюча речовина: Оксид азота (II)Потрібен рецепт
Аналоги NEOPYR в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог NEOPYR у Іспанія
Аналог NEOPYR у Польща
Аналог NEOPYR у Україна
Лікарі онлайн щодо NEOPYR
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на NEOPYR онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
Оберіть спеціаліста або ми підберемо найближчого доступного лікаря.
Лікар розглядає ваш випадок
Зазвичай протягом 30 хвилин. Може ставити уточнювальні запитання в чаті.
Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
NEOPYR потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у NEOPYR — Оксид азота (II). Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
NEOPYR виробляється компанією SOL S.P.A.. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування NEOPYR з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати NEOPYR у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (Оксид азота (II)) включають INALOSSIN, INOMAX, NOXAP. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
















