Imigran

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Sumatriptan succinate 16.8 mg/mL;  

Available from:

GlaxoSmithKline NZ Limited

INN (International Name):

Sumatriptan succinate 16.8 mg/mL

Dosage:

6 mg/0.5mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Sumatriptan succinate 16.8 mg/mL  

Units in package:

Syringe, 0.5ml sample pack, 2 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Divi's Laboratories Limited

Therapeutic indications:

IMIGRAN Injection is indicated for the acute relief of migraine attacks with or without aura, and for the acute treatment of cluster headache.

Product summary:

Package - Contents - Shelf Life: Syringe, 0.5ml sample pack - 2 dose units - 24 months from date of manufacture stored at or below 30°C - Syringe, 0.5ml refill pack - 2 dose units - 24 months from date of manufacture stored at or below 30°C

Authorization date:

1991-04-11

Patient Information leaflet

1
IMIGRAN INJECTION
SUMATRIPTAN SUCCINATE INJECTION 6 MG/0.5 ML
Consumer Medicine Information
WHAT IS IN THIS
LEAFLET?
Please read this leaflet
carefully before you start using
IMIGRAN_ _injection.
This leaflet answers some
common questions about
IMIGRAN_ _injection. It does not
contain all of the available
information.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
IMIGRAN_ _injection against the
benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to
read it again.
WHAT IMIGRAN_ _
INJECTION IS USED FOR
IMIGRAN_ _injection contains the
active ingredient sumatriptan
succinate. This medicine
belongs to a group of drugs
called serotonin agonists.
IMIGRAN_ _injection is used to
relieve headache and other
symptoms of a migraine attack.
It should not be used to
prevent migraine attacks from
occurring. IMIGRAN_ _injection
may be used for migraine
headaches with or without what
is known as 'aura'. There is no
information on the use of
IMIGRAN_ _injection in special
kinds of migraine known as
'basilar migraine',
‘ophthalmoplegic migraine’ or
'hemiplegic migraine'.
It is thought that migraine
headache is due to widening of
certain blood vessels in the
head. IMIGRAN_ _injection works
by making those vessels
normal again and easing the
symptoms of migraine.
IMIGRAN injection is also used
for treatment of cluster
headache.
BEFORE YOU USE YOUR
IMIGRAN INJECTION
_WHEN YOU MUST NOT USE _
_IT _

Do not use IMIGRAN_ _
injection if you have ever
had an allergic reaction to
sumatriptan succinate or
any of the ingredients
listed at the end of this
leaflet.
Symptoms of an allergic
reaction may be mild or
severe. They usually
include some or all of the
following: wheezing,
swelling of the lips/mouth,
difficulty in breathing,
hayfever, lumpy rash
("hives") or fainting.

Do not take IMIGRAN

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
IMIGRAN injection 6 mg/0.5 mL solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 6 mg of sumatriptan base, as the
succinate salt, in
0.5 mL.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Subcutaneous solution for injection.
Pre-filled syringe containing a colourless to pale yellow, isotonic
solution. The pre-filled
syringe can only be used in conjunction with an autoinjector.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
IMIGRAN injection is indicated for the acute relief of migraine
attacks with or without
aura, and for the acute treatment of cluster headache in adults aged
18 years and
over.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dose
IMIGRAN injection should not be used prophylactically. The recommended
dose of
sumatriptan 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. 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.
ADULTS (18 YEARS AND OVER)
Migraine
_ _
The recommended adult dose of IMIGRAN injection is a 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 one
hour between the two doses.
2
The maximum dose in 24 hours is two 6 mg injections (12 mg).
_Cluster Headache_
The recommended adult 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 one hour betw