Peyona (previously Nymusa)

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

Caffeine citrate

Saatavilla:

Chiesi Farmaceutici SpA

ATC-koodi:

N06BC01

INN (Kansainvälinen yleisnimi):

caffeine

Terapeuttinen ryhmä:

Psychoanaleptics,

Terapeuttinen alue:

Apnea

Käyttöaiheet:

Treatment of primary apnoea of premature newborns.

Tuoteyhteenveto:

Revision: 13

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2009-07-02

Pakkausseloste

21
B. PACKAGE LEAFLET
22
PACKAGE LEAFLET: INFORMATION FOR THE USER
PEYONA 20 MG/ML SOLUTION FOR INFUSION AND ORAL SOLUTION
caffeine citrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE TREATMENT WITH THIS MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOUR NEWBORN
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, please ask your baby’s doctor.
-
If your newborn gets any side effects, talk to your baby’s doctor.
This includes any possible
side effects not listed in this leaflet. See section 4.
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
1.
WHAT PEYONA IS AND WHAT IT IS USED FOR
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOUR BABY IS GIVEN PEYONA
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 regurgita

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Peyona 20 mg/mL solution for infusion and oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains 20 mg caffeine citrate (equivalent to 10 mg
caffeine).
Each 1 mL ampoule contains 20 mg_ _caffeine citrate (equivalent to 10
mg caffeine)
Each 3 mL ampoule contains 60 mg caffeine citrate (equivalent to 30 mg
caffeine).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Oral solution.
Clear, colourless, aqueous solution at pH=4.7.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of primary apnoea of premature newborns.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with caffeine citrate should be initiated under the
supervision of a physician experienced in
neonatal intensive care. Treatment should be administered only in a
neonatal intensive care unit in
which adequate facilities are available for patient surveillance and
monitoring.
Posology
The recommended dose regimen in previously untreated infants is a
loading dose of 20 mg caffeine
citrate per kg body weight administered by slow intravenous infusion
over 30 minutes, using a syringe
infusion pump or other metered infusion device. After an interval of
24 hours, maintenance doses of
5 mg per kg body weight may be administered by slow intravenous
infusion over 10 minutes every
24 hours. Alternatively, maintenance doses of 5 mg per kg body weight
may be administered by oral
administration, such as through a nasogastric tube every 24 hours.
The recommended loading dose and maintenance doses of caffeine citrate
are provided in the
following table which clarifies the relationship between injection
volumes and administered doses
expressed as caffeine citrate.
The dose expressed as caffeine base is one-half the dose when
expressed as caffeine citrate (20 mg
caffeine citrate are equivalent to 10 mg caffeine base).
3
Dose of caffeine
citrate (Volume)
Dose of caffeine
citrate (mg/kg body
weight)
Route
Frequency
Lo