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SPC, UK: Caffeine Citrate 10mg/ml Inj. Sol. (2013)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Viridian Pharma Ltd.
Διεύθυνση :
Yew Tree House, Hendrew Lane, Llandevaud, Newport,Gwent, NP18 2AB, UK
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Name of the medicinal product

Caffeine Citrate 10mg/ml Solution for Injection.

Qualitative and quantitative composition

Caffeine Citrate 10mg/ml. Each 1ml of solution contains, 10mg Caffeine citrate, equivalent to 5mg of Caffeine. Each 2ml of solution contains, 20mg Caffeine citrate, equivalent to 10mg of Caffeine. For ...

Pharmaceutical form

Solution for Injection Appearance: clear and colourless.

Therapeutic indications

Treatment of apnoea of prematurity.

Posology and method of administration

The recommended doses of Caffeine Citrate 10mg/ml Solution for Injection are expressed below. Please note: (a) the dose expressed as caffeine citrate is twice the dose expressed as caffeine base. (b) given ...

Contraindications

Caffeine Citrate 10mg/ml Solution for Injection is contraindicated in patients who have demonstrated hypersensitivity to any of its components.

Special warnings and precautions for use

Care should be taken to exclude other causes of apnoea before initiation of treatment. It is advisable to monitor plasma levels of caffeine periodically. However, at the recommended doses, frequent (more ...

Interaction with other medicinal products and other forms of interaction

No clinically significant interactions between caffeine and other medications have been reported in premature infants. Nevertheless, certain clinical situations have a theoretical potential for interaction. ...

Pregnancy and lactation

Not applicable.

Effects on ability to drive and use machines

Not applicable.

Undesirable effects

Caffeine has been reported to cause a number of adverse effects in premature neonates. Effects described include CNS stimulation such as irritability, restlessness and jitteriness and cardiac effects such ...

Overdose

Caffeine overdose has been reported in a few cases in newborns and premature infants. There should normally be no concern with blood levels below 50micrograms/ml; based on limited data, toxicity seems ...

Pharmacodynamic properties

The pharmacological actions of caffeine result from its effect as a nonspecific adenosine receptor antagonist. The desired respirogenic activity of caffeine is an expression of its central nervous system ...

Pharmacokinetic properties

In neonates, orally administered caffeine has been shown to be rapidly and completely absorbed. Peak plasma levels and extent of absorption are comparable for oral administration and intravenous infusion. ...

Preclinical safety data

There is no preclinical data of relevance to the prescriber.

List of excipients

Water for injections Sodium hydroxide Dilute hydrochloric acid Sodium chloride Citric acid

Incompatibilities

This medical product must not be mixed with other medicinal products except those mentioned in section 6.6.

Shelf life

Shelf life: 3 years.

Special precautions for storage

No special precautions for storage.

Nature and contents of container

Type I clear glass ampoule containing 1ml or 2ml in packs of 10 ampoules.

Special precautions for disposal and other handling

Only clear solution without particulate matter should be used. For single use only. Any unused solution should be discarded. There was no detectable degradation of the solution when diluted 50/50 with ...

Marketing authorization holder

Viridian Pharma Ltd. Yew Tree House Hendrew Lane Llandevaud Newport Gwent NP18 2AB UK

Marketing authorization number(s)

PL 20346/0002

Date of first authorization / renewal of the authorization

08/02/2008

Date of revision of the text

21/06/2013