IMIGRAN Nasal spray, solution (2021)
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Περιεχόμενα
Name of the medicinal product
Imigran 10 mg Nasal Spray.
Qualitative and quantitative composition
<u>Imigran 10 mg Nasal Spray:</u> Unit dose spray device for intranasal administration. The device delivers 10 mg of sumatriptan in 0.1 mL of an aqueous buffered solution. For the full list of excipients, ...
Pharmaceutical form
Nasal Spray, solution. Clear pale yellow to dark yellow liquid, in glass vials in a single dose nasal spray device.
Therapeutic indications
Imigran Nasal Spray is indicated for the acute treatment of migraine attacks with or without aura.
Posology and method of administration
Imigran Nasal Spray should not be used prophylactically. The recommended dose of Imigran should not be exceeded. Imigran is recommended as monotherapy for the acute treatment of a migraine attack and should ...
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
Imigran Nasal Spray should only be used where there is a clear diagnosis of migraine. Sumatriptan is not indicated for use in the management of hemiplegic, basilar or ophthalmoplegic migraine. Before treating ...
Interaction with other medicinal products and other forms of interaction
There is no evidence of interactions with propranolol, flunarizine, pizotifen or alcohol. There are limited data on an interaction with preparations containing ergotamine or another triptan/5-HT<sub>1 ...
Pregnancy and lactation
Pregnancy Post-marketing data on the use of sumatriptan during the first trimester of pregnancy in over 1,000 women are available. Although these data contain insufficient information to draw definitive ...
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 (≥1/10,000 to <1/1000) ...
Overdose
Single doses of sumatriptan up to 40 mg intranasally, in excess of 16 mg subcutaneously and 400 mg orally have not been associated with side effects other than those mentioned. In clinical studies volunteers ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Selective 5-HT<sub>1</sub> receptor agonists <b>ATC code:</b> N02CC01 Sumatriptan is a selective vascular 5-hydroxytryptamine-1-(5-HT<sub>1d</sub>) receptor agonist with ...
Pharmacokinetic properties
After intranasal administration, sumatriptan is rapidly absorbed, median times to maximum plasma concentrations being 1.5 (range: 0.25-3) hours in adults and 2 (range: 0.5-3) hours in adolescents. After ...
Preclinical safety data
In non-clinical studies carried out to test for local and ocular irritancy, following administration of sumatriptan nasal spray, there was no nasal irritancy seen in laboratory animals and no ocular irritancy ...
List of excipients
Potassium dihydrogen phosphate Dibasic sodium phosphate anhydrous Sulphuric acid Sodium hydroxide Purified water
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Do not store above 30°C. Do not freeze. Imigran Nasal Spray should be kept in the sealed blister, preferably in the box, to protect from light.
Nature and contents of container
The container consists of a type I Ph.Eur. glass vial with rubber stopper and applicator. <u>Imigran 10 mg Nasal Spray:</u> unit dose spray device containing 0.1mL solution. Pack contains 1, 2, 4, 6, 12, ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Glaxo Wellcome UK Ltd Trading as GlaxoSmithKline UK, 980 Great West Road, Brentford, Middlesex, TW8 9GS
Marketing authorization number(s)
Imigran 10mg Nasal Spray: PL 10949/0260
Date of first authorization / renewal of the authorization
Date of first authorisation: 29/05/1996 Date of last renewal: 29/03/2006
Date of revision of the text
01 October 2021
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