Peyona (caffeine citrate) 20 mg/ml solution for infusion and oral solution
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipient(s)
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
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).
For a 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.
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).
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Dose of caffeine citrate (Volume)
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Dose of caffeine citrate (mg/kg body weight)
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Route
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Frequency
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Loading dose
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1.0 ml/kg body weight
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20 mg/kg body weight
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Intravenous infusion
(over 30 minutes)
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Once
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