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SPC, UK: Peyona (caffeine citrate) 20 mg/ml solution for infusion and oral solution (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Chiesi Limited
Διεύθυνση :
Chiesi Limited, Cheadle Royal Business Park, Highfield, Cheadle, SK8 3GY
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Δωρεάν εγγραφή

Name of the medicinal product

Peyona 20 mg/ml solution for infusion and oral solution.

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. ...

Pharmaceutical form

Solution for infusion. Oral solution. Clear, colourless, aqueous solution at pH=4.7.

Therapeutic indications

Treatment of primary apnoea of premature newborns.

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 ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Special warnings and precautions for use

Apnoea of prematurity is a diagnosis of exclusion. Other causes of apnoea (e.g., central nervous system disorders, primary lung disease, anaemia, sepsis, metabolic disturbances, cardiovascular abnormalities, ...

Interaction with other medicinal products and other forms of interaction

Inter-conversion between caffeine and theophylline occurs in preterm neonates. These active substances should not be used concurrently. Cytochrome P450 1A2 (CYP1A2) is the major enzyme involved in the ...

Pregnancy and lactation

Caffeine in animal studies, at high doses, was shown to be embryotoxic and teratogenic. These effects are not relevant with regard to short term administration in the preterm infant population (see section ...

Effects on ability to drive and use machines

Not relevant.

Undesirable effects

The known pharmacology and toxicology of caffeine and other methylxanthines predict the likely adverse reactions to caffeine citrate. Effects described include central nervous system (CNS) stimulation ...

Overdose

Following overdose, published plasma caffeine levels have ranged from approximately 50 mg/l to 350 mg/l. Signs and symptoms reported in the literature after caffeine overdose in preterm infants include ...

Pharmacodynamic properties

Pharmacotherapeutic group: Xanthine derivatives ATC code: N06BC01 Caffeine is structurally related to the methylxanthines theophylline and theobromine. Most of its effects have been attributed to antagonism ...

Pharmacokinetic properties

Caffeine citrate readily dissociates in aqueous solution. The citrate moiety is rapidly metabolized on infusion or ingestion. Absorption: The onset of action of caffeine from caffeine citrate is within ...

Preclinical safety data

Preclinical data revealed no major hazard for humans based on studies of repeated dose toxicity of caffeine. However, at high doses convulsions in rodents were induced. At therapeutic doses some behavioural ...

List of excipients

Citric acid monohydrate Sodium citrate Water for injections

Incompatibilities

This medicinal product must not be mixed or concomitantly administered in the same intravenous line with other medicinal products except those mentioned in section 6.6.

Shelf life

3 years. After opening the ampoule, the product should be used immediately. From a microbiological point of view, when administered with solutions for infusion the product should be used immediately after ...

Special precautions for storage

This medicinal product does not require any special storage condition. For storage conditions of the diluted medicinal product see section 6.3.

Nature and contents of container

Type I clear glass 1 ml ampoule. Pack size of 10 ampoules.

Special precautions for disposal and other handling

Aseptic technique must be strictly observed throughout handling of the medicinal product since no preservative is present. Caffeine citrate should be inspected visually for particulate matter and discoloration ...

Marketing authorization holder

CHIESI FARMACEUTICI SpA Via Palermo 26/A I-43100 Parma ITALY

Marketing authorization number(s)

EU/1/09/528/002

Date of first authorization / renewal of the authorization

02/07/2009

Date of revision of the text

01/2012