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IMIGRAN Solution for injection (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Imigran Injection. Imigran Subject.

Qualitative and quantitative composition

Each pre-filled syringe contains 6 mg of sumatriptan base, as the succinate salt, in an isotonic solution of 0.5 ml. For a full list of excipients, see section 6.1.

Pharmaceutical form

Pre-filled syringes for use in conjunction with an auto injector for subcutaneous injection.

Therapeutic indications

Subcutaneous Injection is indicated for the acute relief of migraine attacks, with or without aura, and for the acute treatment of cluster headache. Imigran should only be used where there is a clear diagnosis ...

Posology and method of administration

Imigran should not be used prophylactically. The recommended dose of Imigran should not be exceeded. It is recommended to start the treatment at the first sign of a migraine headache or associated symptoms ...

Contraindications

Hypersensitivity to sumatriptan or to any of the excipients listed in section 6.1. Sumatriptan should not be given to patients who have had myocardial infarction or have ischaemic heart disease, coronary ...

Special warnings and precautions for use

Warnings Imigran should only be used where there is a clear diagnosis of migraine or cluster headache. Sumatriptan is not indicated for use in the management of hemiplegic, basilar or opthalmoplegic migraine. ...

Interaction with other medicinal products and other forms of interaction

Studies in healthy subjects show that Imigran does not interact with propranolol, flunarizine, pizotifen or alcohol. There are limited data on an interaction with preparations containing ergotamine or ...

Pregnancy and lactation

Pregnancy Post-marketing data from the use of sumatriptan during the first trimester in over 1,000 women are available. Although these data contain insufficient information to draw definitive conclusions, ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. Drowsiness may occur as a result of migraine or treatment with sumatriptan. This may influence the ability to drive ...

Undesirable effects

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), ...

Overdose

There have been some reports of overdose with Imigran Injection. Patients have received single injections of up to 12 mg subcutaneously without significant adverse effects. Doses in excess of 16 mg subcutaneously ...

Pharmacodynamic properties

<b>Pharmacotherapeutic group:</b> Analgesics: Selective 5-HT<sub>1</sub> receptor agonists <b>ATC Code:</b> N02CC01 Sumatriptan has been demonstrated to be a specific and selective 5-hydroxytryptamine ...

Pharmacokinetic properties

Following subcutaneous injection, sumatriptan has a high mean bioavailability (96%) with peak serum concentrations occurring in 25 minutes. Average peak serum concentration after a 6 mg subcutaneous dose ...

Preclinical safety data

Sumatriptan was devoid of genotoxic and carcinogenic activity in <em>in-vitro</em> systems and animal studies. In a rat fertility study oral doses of sumatriptan resulting in plasma levels approximately ...

List of excipients

Sodium chloride Water for injection

Incompatibilities

None Reported.

Shelf life

Two years when stored below 30°C and protected from light.

Special precautions for storage

Imigran Injection should be stored below 30°C and protected from light.

Nature and contents of container

<u>Treatment pack:</u> 2 pre-filled syringes (in cases) plus an auto-injector, in a plastic tray within a carton. <u>Refill pack:</u> 2 pre-filled syringes (in cases) in a carton or 6 pre-filled syringes ...

Special precautions for disposal and other handling

Patients should be advised to pay strict attention to the instruction leaflet for Imigran Injection, especially regarding the safe disposal of needles and syringes Needles and syringes may be hazardous ...

Marketing authorization holder

Glaxo Wellcome UK Limited Trading as GlaxoSmithKline UK, 980 Great West Road, Brentford, Middlesex, TW8 9GS

Marketing authorization number(s)

PL 10949/0113

Date of first authorization / renewal of the authorization

Date of first authorisation: 31 December 1993 Date of latest renewal: 11 July 2007

Date of revision of the text

22 September 2020

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