20 mg/ml solution for infusion, and oral solution
of caffeine citrate
What Peyona is and what it is used for
Peyona contains the active substance caffeine citrate which is an agent that stimulates the central nervous system and it belongs to a group of medicines called methylxanthines.
Peyona is used in the treatment of respiratory arrest in premature infants (primary apnea in premature infants).
The short periods when premature babies stop breathing are because the baby’s breathing center is not fully developed.
This drug has been shown to reduce the number of episodes of respiratory arrest in premature infants.
What you need to know before giving Peyona to your child
Do not use Peyona
- if your newborn baby is allergic to caffeine citrate or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your baby’s doctor before giving your newborn baby Peyona.
Before starting treatment for apnea in premature babies with Peyona, other causes of apnea should be ruled out or treated appropriately by your child’s doctor.
Peyona should be used with caution. Tell your child’s doctor:
- if your newborn is suffering from seizures
- if your newborn baby is suffering from a heart condition
- if your newborn baby has kidney or liver problems
- if your newborn baby has frequent reflux of stomach contents
- if your newborn baby produces more urine than usual
- if your newborn baby has reduced weight gain or food intake
- if you (the mother) consumed caffeine before giving birth
Other drugs and Peyona
Tell your child’s doctor if your newborn baby has been, has recently been given, or is likely to receive any other medicines.
Tell your baby’s doctor if your newborn baby has previously been treated with theophylline.
Do not use the following medicines during treatment with Peyona without talking to your child’s doctor. Your doctor may need to adjust your dose or change one of these medicines to another:
- theophylline (used to treat breathing difficulties)
- doxapram (used to treat breathing difficulties)
- cimetidine (used to treat stomach ulcers)
- ketoconazole (used to treat fungal infections)
- phenobarbital (used to treat epilepsy )
- phenytoin (used to treat epilepsy ).
This medicine may increase the risk of severe bloody bowel disease ( necrotizing enterocolitis) and is given with medicines to treat stomach ulcer disease (such as histamine H2-receptor blockers or proton pump inhibitors, which reduce gastric acid secretion).
Pregnancy and breastfeeding
If you (the mother) are breastfeeding while your baby is being treated with Peyona, do not drink coffee or take any other products with a lot of caffeine as caffeine is excreted in breast milk.
Peyona contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’.
How Peyona is used
Peyona should only be used in a neonatal intensive care unit where adequate patient monitoring and control equipment is available. Treatment should be started under the supervision of a physician experienced in neonatal intensive care.
Dose
Your child’s doctor will prescribe the right amount of Peyona based on your child’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.
Method of administration and method of administration
Peyona is given by controlled intravenous infusion using a syringe infusion pump or other dose-controlled infusion equipment. This method is also called “drip”.
Some doses (maintenance doses) can be given orally.
To avoid toxic effects, your child’s doctor may need to check caffeine levels through blood tests regularly throughout treatment.
Duration of treatment
Your baby’s doctor will determine exactly how long your newborn baby will need to continue treatment with Peyona.
If your child has not had apnea attacks in 5 to 7 days, your doctor will stop treatment.
If your newborn baby has been given too much Peyona
Your newborn baby may have a fever, rapid breathing ( tachypnea ), flushing, muscle tremors, vomiting, high blood sugar (hyperglycemia), low blood potassium ( hypokalaemia ), high levels of certain substances ( urea ) in the blood, increased number white blood cells ( leukocytes ) in the blood and cramps if he/she receives too much caffeine citrate.
Should this occur, Peyona treatment should be stopped immediately and your child’s doctor should treat the overdose.
If you have any further questions on the use of this product, ask your child’s doctor.
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 common complications in premature babies and complications due to the disease.
During treatment with Peyona, your newborn baby may experience the following side effects:
Serious side effects are
Side effects are where the frequency can not be calculated from the available data
- severe intestinal disease with bloody stools ( necrotizing enterocolitis)
Your child’s doctor may also consider the following side effects to be serious if you look at the clinical assessment as a whole.
Other side effects ar
Commonly reported side effects (may affect up to 1 in 10 people)
- local inflammatory reactions at the infusion site
- heart disorders such as rapid heartbeat ( tachycardia )
- altered blood sugar or serum sugar levels (hyperglycemia)
Uncommon reported side effects (may affect up to 1 in 100 people)
- stimulation of the central nervous system such as seizures
- heart disorders such as irregular heartbeat ( arrhythmia )
Rarely reported side effects (may affect up to 1 in 1,000 people)
- allergic reactions
Side effects are where the frequency can not be calculated from the available data
- infection in the blood ( sepsis )
- altered blood sugar or serum sugar levels (hypoglycemia), impaired growth, food intolerance
- stimulation of the central nervous system such as irritability, nervousness and restlessness, brain damage
- deafness
- regurgitation of stomach contents, increased inhalation of stomach contents
- increased urine production, increased amount of certain substances in the urine ( sodium and calcium )
- changes in blood tests (decreased hemoglobin levels after long-term treatment and decreased levels of thyroid hormone at the beginning of treatment).
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 expiration date is the last day of the specified month.
No special storage instructions.
All ampoules of parenteral solutions must be visually inspected for particulate matter before administration. After opening the ampoules, the medicine should be used immediately.
Contents of the pack and other information
Content declaration
The active substance is caffeine citrate.
Each ml contains 20 mg of caffeine citrate (corresponding to a caffeine base of 10 mg/ml).
Each 1 ml ampoule contains 20 mg of caffeine citrate (equivalent to 10 mg of caffeine base).
Each 3 ml ampoule 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.
What the medicine looks like and the contents of the pack
Peyona is an infusion solution, solution, and oral solution.
Peyona is a clear, colorless solution that is delivered in glass ampoules. Each carton contains 10 ampoules.
Marketing Authorisation Holder
Chiesi Farmaceutici SpA,
Via Palermo 26 / A,
43122 Parma,
Italy
Manufacturer (release batch release)
Alfasigma SpA,
Via Enrico Fermi 1,
Alanna (PE)
Italy
Chiesi Pharmaceuticals GmbH,
Gonzagagasse 16/16,
A-1010 Vienna
Austria
Contact the marketing authorization representative to find out more about this medicine:
| Belgium / Belgique / BelgienChiesi sa / nvTel: + 32 (0) 2 788 42 00 | LithuaniaChiesi Pharmaceuticals GmbHTel: + 43 1 4073919 |
| Bulgaria Chiesi Bulgaria EOODTel .: +359 29201205 | Luxembourg / LuxemburgChiesi sa / nvTel: + 32 (0) 2 788 42 00 |
| Czech RepublicChiesi CZ sroTel: + 420 261221745 | HungaryChiesi Hungary Kft.Tel: +36-1-429 1060 |
| DenmarkChiesi Pharma ABTel: + 46 8 753 35 20 | MaltaChiesi Farmaceutici SpATel: + 39 0521 2791 |
| GermanyChiesi GmbHTel: + 49 40 89724-0 | The NetherlandsChiesi Pharmaceuticals BVTel: +31 88 501 64 00 |
| EestiChiesi Pharmaceuticals GmbHTel: + 43 1 4073919 | NorwayChiesi Pharma ABTel: + 46 8 753 35 20 |
| GreeceChiesi Hellas AEBE:Ηλ: + 30 210 6179763 | AustriaChiesi Pharmaceuticals GmbHTel: + 43 1 4073919 |
| SpainChiesi España, SAUTel: + 34 93 494 8000 | PolandChiesi Poland Sp. ZooTel .: +48 22 620 1421 |
| FranceChiesi SASTel: + 33 1 47688899 | PortugalAngelini Pharmaceuticals, LdaTel: + 351 214 148 300 |
| CroatiaProvidens dooTel .: +385 (1) 48 74 500 | RomaniaChiesi Romania SRLTel: + 40 212023642 |
| IrelandChiesi LtdTel: + 44 (0) 161 488 5555 | SloveniaChiesi Slovenija dooTel: + 386-1-43 00 901 |
| IcelandChiesi Pharma ABPhone: +46 8 753 35 20 | Slovak RepublicChiesi Slovakia sroTel: +421 259300060 |
| ItalyChiesi Italia SpATel: + 39 0521 2791 | Finland / FinlandChiesi Pharma ABPuh / Tel: +46 8 753 35 20 |
| .ΠροςChiesi Farmaceutici SpATηλ: + 39 0521 2791 | SwedenChiesi Pharma ABTel: +46 8 753 35 20 |
| LatviaChiesi Pharmaceuticals GmbHTel: + 43 1 4073919 | United KingdomChiesi Ltd Tel: + 44 (0) 161 488 5555 |