CLUSTRAN sumatriptan (as succinate) 6 mg/0.5 mL injection syringe with autoinjector
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
02-09-2022
Summary of Product characteristics
(SPC)
02-09-2022
Public Assessment Report
(PAR)
20-10-2017
Active ingredient:
sumatriptan, Quantity: 12 mg/mL
Available from:
Sun Pharma ANZ Pty Ltd
INN (International Name):
Sumatriptan
Pharmaceutical form:
Injection, solution
Composition:
Excipient Ingredients: sodium chloride; water for injections
Administration route:
Subcutaneous
Units in package:
2, 1
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
CLUSTRAN injection is indicated for the acute relief of migraine attacks with or without aura., CLUSTRAN injection is also indicated for the acute treatment of cluster headaches.,There is no information available on the use of sumatriptan in the treatment of basilar or hemiplegic migraine.
Product summary:
Visual Identification: A Clear colorless to pale yellow solution filled in 1 ml prefilled syringe, in an autoinjector drug delivery device; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Registered
Authorization date:
2014-06-25
Patient Information leaflet
1
Clustran CMI V8
CLUSTRAN
SOLUTION FOR INJECTION IN PRE-FILLED PEN
_(Sumatriptan succinate)_
________________________________________________________________________________________________________
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you start using Clustran.
This leaflet answers some common
questions about Clustran. 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
Clustran against the risks this
medicine could have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT IS CLUSTRAN USED
FOR?
Clustran contains the active
ingredient sumatriptan succinate.
This medicine belongs to a group of
drugs called serotonin agonists.
Clustran is used to relieve a
migraine attack or cluster headache.
It should not be used to prevent
migraine attacks or cluster
headaches from occurring. Clustran
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. Clustran works by making
those vessels normal again and eases
the symptoms of migraine and cluster
headaches.
Your Clustran does not work in other
types of headache which are not a
migraine or a cluster headache.
Clustran is not addictive.
BEFORE YOU USE
CLUSTRAN
_DO NOT USE IF:_
You must not use Clustran 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 disease
(pain in the back of the
legs) or are prone to cold,
tingling or numb h
Read the complete document
Summary of Product characteristics
1
CLUSTRAN PI V18
AUSTRALIAN PRODUCT INFORMATION CLUSTRAN
sumatriptan (as succinate) solution for injection with autoinjector
1.
NAME OF THE MEDICINE
Sumatriptan (as succinate)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sumatriptan succinate is the therapeutically active ingredient in
CLUSTRAN.
CLUSTRAN 6 mg/0.5 mL injection syringe with autoinjector: Each
pre-filled pen contains
sumatriptan (as succinate) 6 mg in 0.5 mL solution.
For the full list of excipients, see section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
CLUSTRAN sumatriptan (as succinate) 6 mg/0.5 mL is a clear colorless
to pale yellow
solution in prefilled syringe, in an autoinjector drug delivery
device.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
CLUSTRAN is indicated for the acute relief of migraine attacks with or
without aura.
CLUSTRAN is also indicated for the acute treatment of cluster
headaches.
There is no information available on the use of sumatriptan in the
treatment of basilar or
hemiplegic migraine.
4.2 DOSE AND METHOD OF ADMINISTRATION
Product is for single use in one patient only. Discard any residue.
CLUSTRAN is indicated for the acute intermittent relief of both
migraine and cluster
headache. It should not be used prophylactically.
Ergotamine
or
ergotamine
derivatives
and
CLUSTRAN should
not
be
administered
concurrently (see Section 4.3 CONTRAINDICATIONS).
2
CLUSTRAN PI V18
CLUSTRAN should be injected subcutaneously. Patients should be advised
to observe
strictly the instruction leaflet for the CLUSTRAN, especially
regarding the safe disposal of
the pen device (autoinjector).
THE FIRST DOSE OF CLUSTRAN SHOULD BE GIVEN BY, OR UNDER THE DIRECT
SUPERVISION OF,
A PHYSICIAN. As with the administration of the first dose of any
injectable therapeutic
product, appropriate resuscitative equipment should be available.
Appropriate advice on
the future use of CLUSTRAN by the patient should also be given at this
time. The
physician should ensure that the patient is familiar with and
understands the Consumer
Medicine Information.
M
Read the complete document
