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 Φάρμακα Α - Ζ  Συγχορήγηση  Μητρότητα

PHENYLEPHRINE Injection (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Phenylephrine 10 mg/ml Injection.

Qualitative and quantitative composition

Each 1 ml ampoule contains 10 mg of the active ingredient phenylephrine hydrochloride. Excipients with known effect: Sodium hydroxide solution (q.s.- quantity per ml) For the full list of excipients, see ...

Pharmaceutical form

A clear, colourless liquid, free from extraneous visible particles.

Therapeutic indications

Phenylephrine Injection is indicated in adults and children for the treatment of hypotensive states e.g. circulatory failure, during spinal anaesthesia or drug induced hypotension.

Posology and method of administration

Posology Adults Phenylephrine Injection may be administered subcutaneously or intramuscularly in a dosage of 2 to 5 mg with further doses of 1 to 10 mg if necessary according to response, or in a dose ...

Contraindications

Hypersensitivity to phenylephrine or to any of the excipients listed in section 6.1. Patients taking monoamine oxidase inhibitors, or within 14 days of ceasing such treatment. Severe hypertension and hyperthyroidism. ...

Special warnings and precautions for use

Great care should be exercised in administering Phenylephrine Injection to patients with pre-existing cardiovascular disease such as ischaemic heart disease, arrhythmias, occlusive vascular disease including ...

Interaction with other medicinal products and other forms of interaction

Phenylephrine may interact with cyclopropane and halothane and other halogenated inhalational anaesthetics, to induce ventricular fibrillation. An increased risk of arrhythmias may also occur if phenylephrine ...

Pregnancy and lactation

Pregnancy The safety of phenylephrine during pregnancy has not been established. Due to the vasoconstrictive properties of phenylephrine, the product should be used with caution in patients with a history ...

Effects on ability to drive and use machines

No adverse effects known.

Undesirable effects

A tabulated list of undesirable effects is outlined below: The undesirable effects are listed according to organ systems and following frequency: Not known (cannot be estimated from the available data). ...

Overdose

Symptoms Symptoms of overdosage include headache, vomiting, hypertension and reflex bradycardia and other cardiac arrhythmias. In severe cases confusion, hallucinations and seizures may occur. Management ...

Pharmacodynamic properties

Pharmacotherapeutic group: adrenergic and dopaminergic agent ATC code: C01CA Phenylephrine hydrochloride is a sympathomimetic agent with mainly direct effects on adrenergic receptors. It has predominantly ...

Pharmacokinetic properties

Absorption When injected subcutaneously or intramuscularly, phenylephrine takes 10 to 15 minutes to act. Subcutaneous and intramuscular injections are effective for up to about one and up to about two ...

Preclinical safety data

Phenylephrine has been used to induce cardiac myocyte hypertrophy in cultures of rat neonatal mycocytes at doses of 100 µM and 10 µM. To the best of our knowledge there have been no human studies associating ...

List of excipients

Sodium hydroxide solution 1N Hydrochloric acid 36% 1N Water for injections Nitrogen, liquefied

Incompatibilities

Phenylephrine Injection has been stated to be incompatible with alkalies, ferric salts, phenytoin sodium and oxidising agents.

Shelf life

Shelf life: 2 years.

Special precautions for storage

Store at 2-25°C. Protect from light.

Nature and contents of container

1 ml neutral glass ampoule with red imprint break ring. Pack size: 6 1ml and 10 1ml ampoules. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Amdipharm UK Limited, Capital House, 85 King William Street, London EC4N 7BL, UK

Marketing authorization number(s)

PL 20072/0226

Date of first authorization / renewal of the authorization

Date of first authorisation: 17 November 1999 Date of latest renewal: 18 November 2005

Date of revision of the text

20/11/2018

Πηγαίο έγγραφο

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