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SPC: PEYONA Solution (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

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) Each 3 ml ampoule contains 60 mg caffeine citrate ...

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 listed in section 6.1.

Special warnings and precautions for use

Apnoea 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 newborn infants. These active substances should not be used concurrently. Cytochrome P450 1A2 (CYP1A2) is the major enzyme involved ...

Fertility, pregnancy and lactation

Pregnancy 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 ...

Effects on ability to drive and use machines

Not relevant.

Undesirable effects

Summary of the safety profile The known pharmacology and toxicology of caffeine and other methylxanthines predict the likely adverse reactions to caffeine citrate. Effects described include central nervous ...

Overdose

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

Pharmacodynamic properties

Pharmacotherapeutic group: Psychoanaleptics, xanthine derivatives ATC code: N06BC01 Mechanism of action Caffeine is structurally related to the methylxanthines theophylline and theobromine. Most of its ...

Pharmacokinetic properties

Absorption The onset of action of caffeine from caffeine citrate is within minutes of commencement of infusion. After oral administration of 10 mg caffeine base/kg body weight to preterm newborn infants, ...

Preclinical safety data

Non-clinical 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

Shelf life: 3 years. After opening the ampoule, the medicinal product should be used immediately. Chemical and physical compatibility of the diluted solution has been demonstrated for 24 hours at 25°C ...

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. Type I clear glass 3 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. Peyona should be inspected visually for particulate matter and discoloration prior ...

Marketing authorization holder

CHIESI FARMACEUTICI SpA, Via Palermo 26/A, 43122, Parma, ITALY

Marketing authorization number(s)

EU/1/09/528/002 1ml ampoules EU/1/09/528/001 3ml ampoules

Date of first authorization / renewal of the authorization

Date of first authorisation: 02/07/2009 Date of latest renewal: 03/03/2014

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