IMIGRAN Mk II 6mg/0.5mL Injection Syringe

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

sumatriptan succinate, Quantity: 16.8 mg/mL (Equivalent: sumatriptan, Qty 12 mg/mL)

Disponível em:

Aspen Pharmacare Australia Pty Ltd

DCI (Denominação Comum Internacional):

sumatriptan succinate

Forma farmacêutica:

Injection, solution

Composição:

Excipient Ingredients: sodium chloride; water for injections

Via de administração:

Subcutaneous

Unidades em pacote:

2 x 0.5mL

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

Sumatriptan (Imigran) tablets, injection and nasal spray are indicated for the acute relief of migraine attacks with or without aura. Sumatriptan (Imigran) injection is also indicated for the acute treatment of cluster headaches. There is no information available on the use of Imigran injection in the treatment of basilar or hemiplegic migraine.

Resumo do produto:

Visual Identification: Clear colourless to pale yellow liquid practicallyfree from particles; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Status de autorização:

Registered

Data de autorização:

1993-07-13

Folheto informativo - Bula

1
IMIGRAN

MK II INJECTION
_(Sumatriptan succinate) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet
carefully before you start using
_Imigran _Mk II injection.
This leaflet answers some
common questions about
_Imigran _Mk II 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 expected benefits
of you using _Imigran _Mk II
injection against the risks this
medicine could 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 IS _IMIGRAN _MK II
INJECTION USED FOR?
_Imigran_ Mk II injection contains
the active ingredient
sumatriptan succinate. This
medicine belongs to a group of
drugs called serotonin
agonists.
_Imigran_ Mk II injection is used
to relieve a migraine attack or
cluster headache. It should not
be used to prevent migraine
attacks or cluster headaches
from occurring. _Imigran_ Mk II
injection may be used for
migraine headaches with or
without what is known as
'aura'.
It is thought that migraine
headaches and cluster
headaches are due to
widening of certain blood
vessels in the head. _Imigran_
Mk II injection works by making
those vessels normal again
and eases the symptoms of
migraine and cluster
headaches.
Your _Imigran_ Mk II injection
does not work in other types of
headache which are not a
migraine or a cluster
headache.
_Imigran_ Mk II injection is not
addictive.
BEFORE YOU USE
_IMIGRAN _MK II INJECTION
_ _
_DO NOT USE IF: _
You must not use _Imigran_ Mk II
injection if:
•
YOU HAVE EVER HAD AN
ALLERGIC REACTION TO
SUMATRIPTAN SUCCINATE
(SEE “SIDE-EFFECTS”) OR
ANY OF THE INGREDIENTS
LISTED TOWARD THE END OF
THIS LEAFLET. (SEE
“INGREDIENTS”).
•
YOU HAVE OR HAVE HAD:
-
heart disease or heart
attack.
-
shortness of breath,
pain or tightness in the
chest, jaw or upper
arm.
-
peripheral vascular
dis

Características técnicas

1
AUSTRALIAN PRODUCT INFORMATION
IMIGRAN (SUMATRIPTAN) TABLETS, INJECTION AND NASAL SPRAY
1
NAME OF THE MEDICINE
Sumatriptan
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sumatriptan is the therapeutically active ingredient in Imigran nasal
spray and sumatriptan
succinate is the therapeutically active ingredient in Imigran tablets
and injection.
Excipients with known effect: Imigran 50mg and 100mg tablets contain
sugars (as lactose)
IMIGRAN TABLETS 50 MG
Each tablet contains 50 mg sumatriptan base as the succinate salt.
The
tablets
also
contain:
lactose,
lactose
monohydrate,
microcrystalline
cellulose,
croscarmellose sodium, magnesium stearate, Opadry YS-1-1441-G.
IMIGRAN TABLETS 100 MG
Each tablet contains 100 mg sumatriptan base as the succinate salt.
The tablets also contain: lactose monohydrate, microcrystalline
cellulose, croscarmellose
sodium, magnesium stearate, Opadry white OY-S-7393.
IMIGRAN FDT 50 MG
Each tablet contains 50 mg sumatriptan base as the succinate salt.
Imigran
FDT
also
contains:
calcium
hydrogen
phosphate
anhydrous,
microcrystalline
cellulose, sodium bicarbonate, croscarmellose sodium, magnesium
stearate and Opadry YS-
1-1441-G.
IMIGRAN FDT 100 MG
Each tablet contains 100 mg sumatriptan base as the succinate salt.
Imigran
FDT
also
contains:
calcium
hydrogen
phosphate
anhydrous,
microcrystalline
cellulose, sodium bicarbonate, croscarmellose sodium, magnesium
stearate and Opadry
white OY-S-7322.
INJECTION
Imigran MK II injection is available in pre-filled syringes containing
6 mg of sumatriptan base
as the succinate salt, in an isotonic solution containing sodium
chloride and water for
injections (total volume 0.5 mL).
2
IMIGRAN NASAL SPRAY
Each nasal spray is a single dose unit of sumatriptan base in 0.1 mL
aqueous solution
containing sulfuric acid, monobasic potassium phosphate, dibasic
anhydrous sodium
phosphate, sodium hydroxide and purified water. The pH of the nasal
spray solution is 5.5.
3
PHARMACEUTICAL FORM
TABLETS
Sumatriptan tablets are presented in two formulations: Imigran tablets