Інструкція із застосування PEYONA
Зміст інструкції
Peyona 20 mg/mL solution for infusion and oral solution
caffeine citrate
Read this leaflet carefully before treatment with this medicine as it contains
important information for your newborn.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your child's doctor.
- If your newborn experiences any side effects, including those not listed in this leaflet, ask your child's doctor. See section 4.
Contents of this leaflet
- 1. What Peyona is and what it is used for
- 2. What you need to know before Peyona is given to your child
- 3. How to use Peyona
- 4. Possible side effects
- 5. How to store Peyona
- 6. Contents of the pack and other information
1. What is Peyona and what is it used for
Peyona contains the active ingredient caffeine citrate, which is a stimulant of the central nervous system
that belongs to a group of drugs called methylxanthines.
Peyona is used for the treatment of respiratory cessation in premature infants (primary apnea
of premature infants).
These brief interruptions in the breathing of premature infants are caused by the incomplete development
of the baby's respiratory centers.
This medicine has been shown to reduce the number of episodes of respiratory cessation in
premature infants.
2. What you need to know before Peyona is given to your child
Do not use Peyona
- if your child is allergic to caffeine citrate or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your child's doctor before Peyona is given to your newborn.
Before starting treatment for prematurity apnea with Peyona, your child's doctor must have excluded, or appropriately treated, any other possible cause of apnea.
Peyona must be used with caution. Tell your doctor if:
- your child suffers from convulsions
- your child has any heart problems
- your child has kidney or liver problems
- your child experiences frequent episodes of regurgitation
- your child produces more urine than usual
- your child has a low body weight or insufficient food intake
- if you (mother) have taken caffeine before delivery
Other medicines and Peyona
Tell your child's doctor if your newborn is taking, has recently taken or might take any other medicines.
Tell your child's doctor if your newborn has received previous treatment with theophylline.
Do not use the following medicines during treatment with Peyona without first consulting your child's doctor. The doctor may need to change the dosage or change one of the medicines:
- theophylline (used to treat breathing difficulties)
- doxapram (used to treat breathing difficulties)
- cimetidine (used to treat stomach disorders)
- ketoconazole (used to treat fungal infections)
- phenobarbital (used to treat epilepsy)
- phenytoin (used to treat epilepsy)
This medicine may increase the risk of a serious intestinal disease with blood in the stool (necrotizing enterocolitis) if given at the same time as medicines used to treat a stomach disorder (such as H2 receptor blockers or proton pump inhibitors that reduce stomach acid secretion).
Pregnancy and breastfeeding
If you (mother) are breastfeeding while your child is being treated with Peyona, you should not drink coffee or take other products with high caffeine content because it is excreted in breast milk.
Peyona contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.
3. How to use Peyona
Peyona must be used only in a neonatal intensive care unit equipped with
suitable equipment for monitoring and surveillance of patients. Treatment must be
initiated under the supervision of a physician experienced in neonatal intensive care.
Dosage
Your child's doctor will prescribe the correct dose of Peyona based on weight.
The loading dose is 20 mg per kg of body weight (equivalent to 1 mL per kg of body weight).
The maintenance dose is 5 mg per kg of body weight (equivalent to 0.25 mL per kg of body weight)
every 24 hours.
Route and method of administration
Peyona will be administered by controlled intravenous infusion, through a syringe pump or another
device with measured delivery. This method is also
known as "drip".
Some doses (maintenance doses) may be administered orally.
Your child's doctor may need to periodically check
caffeine levels in your child's blood during therapy to avoid toxic effects.
Duration of treatment
Your child's doctor will decide exactly how long he should continue therapy with
Peyona. If your child has 5 to 7 days without apnea attacks, the doctor will stop the
treatment.
If your child receives more Peyona than he should
Your child may experience fever, rapid breathing (tachypnea), nervousness, muscle tremors,
vomiting, high blood sugar levels (hyperglycemia), low potassium levels (hypokalemia),
high levels of certain chemicals (urea), a high number of certain blood cells
(white blood cells) and convulsions, if he receives too much caffeine citrate.
In such a case, treatment with Peyona must be stopped immediately and your child's
doctor must treat the overdose.
If you have any doubts about the use of this medicine, ask your child's doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
However, it is difficult to distinguish them from some frequent complications that occur in
premature infants and from complications due to the illness.
During treatment with Peyona, your newborn may experience some of the following reactions:
Serious side effects
Side effectswhose frequency cannot be defined on the basis of the available data
- serious intestinal disease with blood in the stool (necrotizing enterocolitis)
Also, the other side effects that follow may be considered serious by your child's doctor in the
context of the overall clinical assessment.
Other side effects
Side effects commonreported (may affect up to 1 in 10 people)
- local inflammatory reactions at the infusion site
- heart disorders such as an accelerated heart rate (tachycardia)
- changes in blood sugar or serum levels (hyperglycemia)
Side effects uncommonreported (may affect up to 1 in 100 people)
- stimulation of the central nervous system such as convulsions
- heart disorders such as an irregular heart rate (arrhythmia)
Side effects rare(may affect up to 1 in 1,000):
- allergic reactions
Side effectswhose frequency cannot be defined on the basis of the available data
- blood infections (sepsis)
- changes in blood sugar or serum levels (hypoglycemia), stunted growth, food intolerance
- stimulation of the central nervous system such as irritability, nervousness and agitation; brain injury
- deafness
- regurgitation, increased gastric aspirate
- increased urine flow, increased levels of some urine components (sodium and calcium)
- changes in blood tests (reduced hemoglobin levels after prolonged treatment and reduced thyroid hormone levels at the beginning of treatment)
Reporting of side effects
If your newborn experiences any side effect, including those not listed in this
leaflet, please inform your child's doctor. You can also report side effects directly
through the national reporting system as reported in Annex V.
By reporting side effects you can help provide more information on the safety of
this medicine.
5. How to store Peyona
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. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Before administration, the vials of all solutions for parenteral use must be visually inspected
to exclude the presence of any suspended particles.
After opening the vial, the medicine must be used immediately.
6. Contents of the pack and other information
What Peyona contains
The active ingredient is caffeine citrate.
Each mL contains 20 mg of caffeine citrate (equivalent to 10 mg/mL of caffeine base).
Each vial of 1 mL contains 20 mg of caffeine citrate (equivalent to 10 mg of caffeine base).
Each vial of 3 mL contains 60 mg of caffeine citrate (equivalent to 30 mg of caffeine base).
The other ingredients are citric acid, sodium citrate and water for injections.
Description of Peyona and contents of the pack
Peyona is a solution for infusion and an oral solution.
Peyona is a transparent, colourless solution presented in glass vials. Each pack contains
10 vials.
Marketing Authorisation Holder
Chiesi Farmaceutici S.p.A,
Via Palermo 26/A,
43122 Parma,
Italy
Manufacturer (Batch Release)
Alfasigma S.p.A.,
Via Enrico Fermi 1,
Alanno (PE)
Italy
Chiesi Pharmaceuticals GmbH,
Gonzagagasse 16/16,
A-1010 Wien
Austria
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:
België/Belgique/Belgien
Chiesi sa/nv
Tél/Tel: + 32 (0)2 788 42 00
Lietuva
Chiesi Pharmaceuticals GmbH
Tel: + 43 1 4073919
България
Chiesi Bulgaria EOOD
Тел.: +359 29201205
Luxembourg/Luxemburg
Chiesi sa/nv
Tél/Tel: + 32 (0)2 788 42 00
Česká republika
Chiesi CZ s.r.o.
Tel: + 420 261221745
Magyarország
Chiesi Hungary Kft.
Tel.: + 36-1-429 1060
Danmark
Chiesi Pharma AB
Tlf: + 46 8 753 35 20
Malta
Chiesi Farmaceutici S.p.A
Tel: + 39 0521 2791
Deutschland
Chiesi GmbH
Tel: + 49 40 89724-0
Nederland
Chiesi Pharmaceuticals B.V.
Tel: +31 88 501 64 00
Eesti
Chiesi Pharmaceuticals GmbH
Tel: + 43 1 4073919
Norge
Chiesi Pharma AB
Tlf: + 46 8 753 35 20
Ελλάδα
Chiesi Hellas AEBE
Τηλ: + 30 210 6179763
Österreich
Chiesi Pharmaceuticals GmbH
Tel: + 43 1 4073919
España
Chiesi España, S.A.U.
Tel: + 34 93 494 8000
Polska
Chiesi Poland Sp. z.o.o.
Tel.: +48 22 620 1421
France
Chiesi S.A.S
Tél: + 33 1 47688899
Portugal
Chiesi Farmaceutici S.p.A.
Tel: + 39 0521 2791
Hrvatska
Providens d.o.o.
Tel.: +385 (1) 48 74 500
România
Chiesi Romania S.R.L.
Tel: + 40 212023642
Ireland
Chiesi Farmaceutici S.p.A.
Tel: + 39 0521 2791
Slovenija
Chiesi Slovenija d.o.o.
Tel: +386-1-43 00 901
Ísland
Chiesi Pharma AB
Sími: +46 8 753 35 20
Slovenská republika
Chiesi Slovakia s.r.o.
Tel: +421 259300060
Italia
Chiesi Italia S.p.A.
Tel: + 39 0521 2791
Suomi/Finland
Chiesi Pharma AB
Puh/Tel: +46 8 753 35 20
Κύπρος
Chiesi Farmaceutici S.p.A.
T : + 39 0521 2791
Sverige
Chiesi Pharma AB
Tel: +46 8 753 35 20
Latvija
Chiesi Pharmaceuticals GmbH
Tel: + 43 1 4073919
United Kingdom (Northern Ireland)
Chiesi Farmaceutici S.p.A.
Tel: + 39 0521 2791
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu .
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The following information is intended exclusively for doctors and healthcare professionals:
For detailed information, please refer to the enclosed Summary of Product Characteristics for PEYONA

- Країна реєстрації
- Лікарська формаInfusion solution, 20MG/ML
- Код АТХN06BC01
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до PEYONAЛікарська форма: Infusion solution, 10 MG / MLДіюча речовина: КофеинВиробник: GENNISIUM PHARMAПотрібен рецептЛікарська форма: Coated tablet, 5 MGДіюча речовина: dexamfetamineВиробник: MEDICE ARZNEIMITTEL PUETTER GMBH & CO.KGПотрібен рецептЛікарська форма: Injectable solution, 250 MGДіюча речовина: цитиколинВиробник: S.F. GROUP S.R.L.Потрібен рецепт
Аналоги PEYONA в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог PEYONA у Польща
Аналог PEYONA у Україна
Аналог PEYONA у Іспанія
Лікарі онлайн щодо PEYONA
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на PEYONA 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
PEYONA потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у PEYONA — Кофеин. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
PEYONA виробляється компанією CHIESI FARMACEUTICI 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 PEYONA 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 PEYONA 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 (Кофеин) включають JENKEBOK, AMFEXA, KIDILIN. 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.
















