Imigran Subject 6mg/0.5ml solution for injection pre-filled syringes with device

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Sumatriptan succinate

Disponible depuis:

GlaxoSmithKline UK Ltd

Code ATC:

N02CC01

DCI (Dénomination commune internationale):

Sumatriptan succinate

Dosage:

12mg/1ml

forme pharmaceutique:

Solution for injection

Mode d'administration:

Subcutaneous

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 04070401; GTIN: 5000123106264

Notice patient

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
IMIGRAN SUBJECT
SUMATRIPTAN SOLUTION FOR INJECTION IN PRE-FILLED CARTRIDGES
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others - it may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1
WHAT IMIGRAN SUBJECT IS AND WHAT IT IS USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU USE IMIGRAN SUBJECT
3
HOW TO USE IMIGRAN SUBJECT
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE IMIGRAN SUBJECT
6
CONTENTS OF THE PACK AND OTHER INFORMATION
7
STEP-BY-STEP GUIDE TO USING IMIGRAN SUBJECT
1
WHAT IMIGRAN SUBJECT IS AND WHAT IT IS USED FOR
EACH IMIGRAN SUBJECT PRE-FILLED CARTRIDGE SYRINGE CONTAINS A SINGLE
DOSE
of sumatriptan, which
belongs to a group of medicines called triptans
_(also known as 5-HT_
_1_
_ receptor agonists). _
IMIGRAN SUBJECT IS USED TO TREAT MIGRAINE HEADACHE
AND A RARE CONDITION CALLED CLUSTER HEADACHE.
Migraine
and cluster headache symptoms may be caused by the temporary widening
of blood vessels
in the head. Imigran Subject
is believed to reduce the widening of these blood vessels. This in
turn
helps to take away the headache and relieve other symptoms such as
feeling or being sick (nausea or
vomiting) and sensitivity to light and sound.
_ _
2
WHAT YOU NEED TO KNOW BEFORE YOU USE IMIGRAN SUBJECT
DON’T USE IMIGRAN SUBJECT:
•
IF YOU’RE ALLERGIC
to sumatriptan, or any of the other ingredients of this medicine
(listed in section
6)
•
IF YOU HAVE A HEART PROBLEM
such as narrowing of the arteries
_(ischaemic heart disease)_
or chest
pains
_(angina)_
, or have already had a heart attack
•
IF YOU HAVE CIRCULATION PRO

Résumé des caractéristiques du produit

OBJECT 1
IMIGRAN INJECTION, SUBJECT
Summary of Product Characteristics Updated 04-May-2018 |
GlaxoSmithKline UK
1. Name of the medicinal product
Imigran Injection
Imigran Subject
2. 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
3. Pharmaceutical form
Pre-filled syringes for use in conjunction with an auto injector for
subcutaneous injection.
4. Clinical particulars
4.1 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 of
migraine or cluster headache.
4.2 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
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 responde