IMIGRAN Solution for injection Ref.[7804] Active ingredients: Sumatriptan

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 such as nausea, vomiting or photophobia. It is equally effective at whatever stage of the attack it is administered.

The efficacy of sumatriptan 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.

Migraine

Adult

The recommended adult dose of Imigran is a single 6 mg subcutaneous injection.

If a patient does not respond to the first dose of sumatriptan, a second dose should not be taken for the same attack. In these cases the attack can be treated with paracetamol, acetylsalicylic acid, or non-steroidal anti-inflammatory drugs. Sumatriptan 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).

Imigran is recommended as monotherapy for the acute treatment of migraine and should not be given concomitantly with ergotamine or derivatives of ergotamine (including methysergide) (see section 4.3).

Cluster headache

Adult

The recommended adult dose is a single 6mg subcutaneous injection for each cluster attack. The maximum dose in 24 hours is two 6 mg injections (12 mg) with a minimum interval of one hour between the two doses.

Children and Adolescents (under 18 years of age)

Sumatriptan Injection is not recommended for use in children and adolescents due to insufficient data on safety and efficacy.

Older people (over 65)

Experience of the use of Imigran 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 Sumatriptan in patients aged over 65 years is not recommended.

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 were not associated with side effects other than those mentioned.

If overdose with Imigran occurs, the patient should be monitored for at least ten hours and standard supportive treatment applied as required.

It is unknown what effect haemodialysis or peritoneal dialysis has on the plasma concentrations of Imigran.

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

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

Treatment pack: 2 pre-filled syringes (in cases) plus an auto-injector, in a plastic tray within a carton.

Refill pack: 2 pre-filled syringes (in cases) in a carton or 6 pre-filled syringes (ie three cases each containing 2 pre-filled syringes).

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 and should be disposed of safely and hygienically.