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PHENERGAN Solution for injection (2016)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Phenergan 25mg/ml Solution for Injection.

Qualitative and quantitative composition

Each ampoule contains 25mg/ml of the active substance Promethazine hydrochloride. Also contains 0.5mg of sodium sulphite anhydrous (E221) and 0.7mg of sodium metabisulphite (E223). For a full list of excipients, ...

Pharmaceutical form

Solution for injection. Phenergan Injection is a clean, bright, colourless or almost colourless solution.

Therapeutic indications

As symptomatic treatment for allergic conditions of the upper respiratory tract and skin including allergic rhinitis, urticaria and anaphylactic reactions to drugs and foreign proteins. Sedation and treatment ...

Posology and method of administration

Route of administration Intramuscular or intravenous (after dilution) The usual dose is 25-50 mg by deep intramuscular injection, or, in emergency, by slow intravenous injection after dilution of the 2.5% ...

Contraindications

Phenergan should not be used in patients in coma or suffering from CNS depression of any cause. Phenergan should not be given to patients with a known hypersensitivity to promethazine or to any of the ...

Special warnings and precautions for use

Phenergan may thicken or dry lung secretions and impair expectoration. It should therefore be used with caution in patients with asthma, bronchitis or bronchiectasis. Use with care in patients with severe ...

Interaction with other medicinal products and other forms of interaction

Phenergan will enhance the action of any anticholinergic agent, tricyclic antidepressant, sedative or hypnotic. Alcohol should be avoided during treatment. Phenergan may cause hypotension, and dosage adjustment ...

Pregnancy and lactation

Phenergan Injection should not be used in pregnancy unless the physician considers it essential. The use of Phenergan is not recommended in the 2 weeks prior to delivery in view of the risk of irritability ...

Effects on ability to drive and use machines

Ambulant patients receiving Phenergan for the first time should not be in control of vehicles or machinery for the first few days until it is established that they are not hypersensitive to the central ...

Undesirable effects

The following CIOMS frequency rating is used: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to ≥1/1000); very rare (<1/10 000), not known (cannot be estimated ...

Overdose

Symptoms of severe overdosage are variable. They are characterised in children by various combinations of excitation, ataxia, incoordination, athetosis and hallucinations, while adults may become drowsy ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antihistamines for systemic use; Phenothiazine derivatives ATC code: R06AD02 Potent, long acting, antihistamine with additional anti-emetic central sedative and anti-cholinergic ...

Pharmacokinetic properties

Promethazine is slowly excreted via urine and bile. It is distributed widely in the body. It enters the brain and crosses the placenta. Phenothiazines pass into the milk at low concentrations.

Preclinical safety data

No additional data of relevance to the prescriber.

List of excipients

Sodium sulphite anhydrous (E221) Sodium metabisulphite (E223) Water for injections

Incompatibilities

Not applicable.

Shelf life

3 years.

Special precautions for storage

Store in the original carton in order to protect from light.

Nature and contents of container

Cardboard carton containing either 10 1 ml ampoules or 10 2 ml ampoules. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Discoloured solutions should not be used.

Marketing authorization holder

Aventis Pharma Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, UK or trading as: Sanofi-aventis or Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Marketing authorization number(s)

PL 04425/0648

Date of first authorization / renewal of the authorization

Date of first authorisation: 16 March 1973 Date of latest renewal: 29 July 2002

Date of revision of the text

17 August 2016

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