Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION
**Dosage and Administration** IMIGRAN should not be used prophylactically. The recommended dose of IMIGRAN should not be exceeded. It is advisable that IMIGRAN be given as early as possible after the onset of a migraine headache or associated symptoms such as nausea, vomiting or photophobia. It is equally effective at whatever stage of the attack it is administered. The efficacy of IMIGRAN is independent of the duration of the attack when starting treatment. Administration during a migraine aura prior to other symptoms occurring may not prevent the development of a headache. IMIGRAN injection should be injected subcutaneously using an auto-injector. Patients should be advised to observe strictly the instruction leaflet for the IMIGRAN auto-injector, especially regarding the safe disposal of syringes and needles. **Populations** - **Adults** **Migraine** The recommended dose of IMIGRAN injection is a single 6 mg subcutaneous injection. If a patient does not respond to the first dose of IMIGRAN, a second dose should not be taken for the same attack. IMIGRAN injection may be taken for subsequent attacks. If the patient has responded to the first dose, but the symptoms recur, a second dose may be given in the next 24 hours, provided that there is a minimum interval of 1 hour between the two doses. The maximum dose in 24 hours is two 6 mg injections (12 mg). **Cluster headache** The recommended dose of IMIGRAN injection is a single 6 mg subcutaneous injection for each cluster attack. The maximum dose in 24 hours is two 6 mg injections (12 mg) with a minimum interval of 1 hour between the two doses. - **Children and Adolescents (under 18 years of age)** IMIGRAN injection has not been studied in adolescents or children. - **Elderly (over 65 years of age)** Experience of the use of sumatriptan in patients aged over 65 years is limited. The pharmacokinetics do not differ significantly from a younger population, but until further clinical data are available, the use of IMIGRAN in patients aged over 65 years is not recommended.
SUBCUTANEOUS
Medical Information
**Indications** IMIGRAN injection is indicated for the acute relief of migraine attacks with or without aura, including the acute treatment of migraine attacks associated with the menstrual period in women. IMIGRAN injection is also indicated for the acute treatment of cluster headache.
**Contraindications** - Hypersensitivity to any component of the preparation. - IMIGRAN should not be given to patients who have had myocardial infarction or have ischaemic heart disease (IHD), Prinzmetal's angina/coronary vasospasm, peripheral vascular disease or patients who have symptoms or signs consistent with IHD. - IMIGRAN should not be administered to patients with a history of previous cerebrovascular accident (CVA) or transient ischaemic attack (TIA). - The use of IMIGRAN in patients with uncontrolled hypertension is contraindicated. - IMIGRAN should not be administered to patients with severe hepatic impairment. - The concomitant use of ergotamine or derivatives of ergotamine (including methysergide) is contraindicated ( _see Interactions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - Concurrent administration of monoamine oxidase inhibitors (MAOIs) and IMIGRAN is contraindicated. IMIGRAN must not be used within two weeks of discontinuation of therapy with MAOIs.
N02CC01
sumatriptan
Manufacturer Information
GLAXOSMITHKLINE PTE LTD
GLAXO OPERATIONS UK LTD (TRADING AS GLAXO WELLCOME OPERATIONS)
Active Ingredients
Documents
Package Inserts
IMIGRAN inj_PI.pdf
Approved: February 12, 2018