Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - peyona

Document Subject

Generated Narrative: MedicinalProductDefinition mp8e38350ad4085562476adf145c0f9fae

identifier: http://ema.europa.eu/identifier/EU/1/09/528/002 1 mL ampoules

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Peyona 20 mg/mL solution for infusion and oral solution

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-8e38350ad4085562476adf145c0f9fae

identifier: http://ema.europa.eu/identifier/EU/1/09/528/002 1 mL ampoules

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - peyona

Attesters

What is in this leaflet

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

Peyona contains the active substance caffeine citrate, which is a stimulant of the central nervous system, belonging to a group of medicines called methylxanthines. Peyona is used in the treatment of interrupted breathing in premature babies (primary apnoea of premature newborns). These short periods when premature babies stop breathing are due to the baby s breathing centres not being fully developed. This medicine has been shown to reduce the number of episodes of interrupted breathing in premature newborns.

Do not use Peyona

If your newborn is allergic to caffeine citrate or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your baby s doctor before your newborn is given Peyona. Prior to starting treatment for apnoea of prematurity with Peyona other causes of apnoea should have been excluded or properly treated by your baby s doctor. Peyona should be used with caution. Please inform your baby s doctor:

If your newborn suffers from seizures

If your newborn suffers from any heart disease

If your newborn has kidney or liver problems

If your newborn has frequent regurgitation

If your newborn produces more urine than usual

If your newborn has a reduced weight gain or food intake

If you (the mother) consumed caffeine prior to delivery Other medicines and Peyona Tell your baby s doctor if your newborn is taking, have recently taken or might take any other medicines. Please inform your baby s doctor if your newborn has been previously treated with theophylline. Do not use the following medicines during the treatment with Peyona without talking to your baby s doctor. The doctor may need to adjust the dose or change one of the medicines to something else:

theophylline (used to treat breathing difficulties)

doxapram (used to treat breathing difficulties)

cimetidine (used to treat gastric disease)

ketoconazole (used to treat fungine infections)

phenobarbital (used to treat epilepsy)

phenytoin (used to treat epilepsy) This medicine may increase the risk for serious intestinal disease with bloody stools (necrotising enterocolitis) when administered with medicines used to treat gastric disease (such as antihistamine H2 receptor blockers or proton-pump inhibitors that reduces gastric acid secretion). Pregnancy and breast-feeding If you (the mother) are breast-feeding while your infant is treated with Peyona, you should not drink coffee or take any other high caffeine product as caffeine passes into breast milk. Peyona contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium- free .

Peyona should only be used in a neonatal intensive care unit in which adequate facilities are available for patient surveillance and monitoring. Treatment should be initiated under supervision of a physician experienced in neonatal intensive care. Dose Your baby s doctor will prescribe the right amount of Peyona based on your baby s weight. The starting dose is 20 mg per kg body weight (equivalent to 1 mL per kg body weight). The maintenance dose is 5 mg per kg body weight (equivalent to 0.25 mL per kg body weight) every 24 hours. Route and method of administration Peyona will be infused by controlled intravenous infusion, using a syringe infusion pump or other metered infusion device. This method is also known as a drip . Some of the doses (maintenance doses) may be given by mouth. It may be needed that your baby s doctor decides to check the levels of caffeine in a blood test periodically throughout treatment to avoid toxicity. Duration of treatment Your baby s doctor will decide exactly how long your newborn must continue therapy with Peyona. If your baby has 5 to 7 days without apnoea attacks, the doctor will stop the treatment. If your newborn receives more Peyona than he/she should Your newborn may experience fever, rapid breathing (tachypnoea), jitteriness, muscular tremor vomiting, high blood levels of sugar (hyperglycemia), low blood levels of potassium (hypokalaemia), high blood levels of certain chemicals (urea), elevated number of certain cells (leukocyte) in blood and seizures if he/she receives more caffeine citrate than he/she should. In the event of this happening treatment with Peyona should be stopped immediately and your baby s doctor should treat the overdose. If you have any further questions on the use of this medicinal product, ask your baby s doctor.

Like all medicines, this medicine can cause side effects, although not everybody gets them. However, it is difficult to distinguish them from frequent complications occurring in premature babies and complications due to the disease. While under treatment with Peyona, your newborn may experience some of the following reactions: Serious side effects Side effects where the frequency cannot be estimated from the available data

serious intestinal disease with bloody stools (necrotising enterocolitis) The following other side effects may also be considered serious by your baby s doctor in the context of the global clinical evaluation. Other side effects Common reported side effects (may affect up to 1 in 10 people)

local inflammatory reactions at the infusion site

cardiac disorders such as fast heart beat (tachycardia)

changes of sugar in blood or serum (hyperglycaemia) Uncommon reported side effects (may affect up to 1 in 100 people)

stimulation of central nervous system such as convulsion

cardiac disorders such as irregular heart beat (arrhythmia) Rare reported side effects (may affect up to 1 in 1,000 people)

allergic reactions Side effects where the frequency cannot be estimated from the available data

bloodstream infection (sepsis)

changes of sugar in blood or serum (hypoglycaemia ), failure to grow, feeding intolerance

stimulation of central nervous system such as irritability, nervousness and restlessness; brain injury

deafness

regurgitation, increase in stomach aspirate

increase of urine flow, increase of certain urine components (sodium and calcium)

changes in blood tests (reduced levels of haemoglobin after prolonged treatment and reduced thyroid hormone at the start of treatment) Reporting of side effects If your newborn gets any side effects, talk to your baby s doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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. The medicinal product does not require any special storage conditions. Ampoules of all parenteral solutions must be inspected visually for particulate matter prior to administration. After opening the ampoules, the medicinal product should be used immediately.

What Peyona contains The active substance is caffeine citrate. Each mL contains 20 mg caffeine citrate (equivalent to 10 mg/mL of caffeine base). Each 1 mL ampoule contains 20 mg caffeine citrate (equivalent to 10 mg of caffeine base). Each 3 mL ampoule contains 60 mg caffeine citrate (equivalent to 30 mg of caffeine base). The other ingredients are citric acid, sodium citrate and water for injections. What Peyona looks like and content of the pack Peyona is a solution for infusion and oral solution. Peyona is a clear, colourless solution, supplied in glass ampoules. Each carton contains 10 ampoules. 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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Chiesi sa/nv T l/Tel: + 32 (0)2 788 42 Lietuva Chiesi Pharmaceuticals GmbH Tel: + 43 1 4073
Chiesi Bulgaria EOOD .: +359 29201Luxembourg/Luxemburg Chiesi sa/nv T l/Tel: + 32 (0)2 788 42 esk republika Chiesi CZ s.r.o. Tel: + 420 261221Magyarorsz g Chiesi Hungary Kft. Tel.: +36-1-429 1Danmark Chiesi Pharma AB Tlf: + 46 8 753 35 Malta Chiesi Farmaceutici S.p.A Tel: + 39 0521 2Deutschland Chiesi GmbH Tel: + 49 40 89724-0 Nederland Chiesi Pharmaceuticals B.V. Tel: +31 88 501 64 Eesti Chiesi Pharmaceuticals GmbH Tel: + 43 1 4073Norge Chiesi Pharma AB Tlf: + 46 8 753 35
Chiesi Hellas AEBE : + 30 210 6179 sterreich Chiesi Pharmaceuticals GmbH Tel: + 43 1 4073Espa a Chiesi Espa a, S.A.U. Tel: + 34 93 494 8Polska Chiesi Poland Sp. z.o.o. Tel.: +48 22 620 1France Chiesi S.A.S T l: + 33 1 47688Portugal Angelini Farmac utica, Lda Tel: + 351 214 148 Hrvatska Providens d.o.o. Tel.: +385 (1) 48 74 Rom nia Chiesi Romania S.R.L. Tel: + 40 212023Ireland Chiesi Farmaceutici S.p.A. Tel: + 39 0521 2Slovenija Chiesi Slovenija d.o.o. Tel: +386-1-43 00 sland Chiesi Pharma AB S mi: +46 8 753 35 Slovensk republika Chiesi Slovakia s.r.o. Tel: +421 259300Italia Chiesi Italia S.p.A. Tel: + 39 0521 2Suomi/Finland Chiesi Pharma AB Puh/Tel: +46 8 753 35
Sverige Chiesi Farmaceutici S.p.A. T : + 39 0521 2Chiesi Pharma AB Tel: +46 8 753 35 Latvija Chiesi Pharmaceuticals GmbH Tel: + 43 1 4073United Kingdom (Northern Ireland) Chiesi Farmaceutici S.p.A. Tel: + 39 0521 2This leaflet was last revised in. Detailed information on this medicine is available on the website of the European Medicines Agency