Peyona 20mgml solution for infusion ampoules

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Caffeine citrate

Disponibil de la:

Chiesi Ltd

INN (nume internaţional):

Caffeine citrate

Dozare:

20mg/1ml

Forma farmaceutică:

Solution for infusion

Calea de administrare:

Oral; Intravenous

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: ; GTIN: 5028613002834

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE USER
PEYONA 20 MG/ML SOLUTION FOR INFUSION AND ORAL SOLUTION
CAFFEINE CITRATE
42001785
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 regurgitation
•
If you

Caracteristicilor produsului

OBJECT 1
PEYONA (CAFFEINE CITRATE) 20 MG/ML SOLUTION FOR
INFUSION AND ORAL SOLUTION
Summary of Product Characteristics Updated 20-Oct-2017 | Chiesi
Limited
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