Zomig Nasal Spray

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

Zolmitriptan 5mg

Beschikbaar vanaf:

AstraZeneca Limited

INN (Algemene Internationale Benaming):

Zolmitriptan 5 mg

Dosering:

5 mg

farmaceutische vorm:

Nasal spray solution

Samenstelling:

Active: Zolmitriptan 5mg Excipient: Citric acid Dibasic sodium phosphate dihydrate Purified water

Eenheden in pakket:

Vial, glass, single dose, 5mg, + spray device, Physician sample pack, 2 dose units

klasse:

Restricted

Prescription-type:

Restricted

Geproduceerd door:

Dottikon Exclusive Synthesis AG

Product samenvatting:

Package - Contents - Shelf Life: Vial, glass, single dose, 5mg, + spray device, Physician sample pack - 2 dose units - 24 months from date of manufacture stored at or below 25°C - Vial, glass, single dose, 5mg, + spray device - 2 dose units - 24 months from date of manufacture stored at or below 25°C

Autorisatie datum:

2010-09-03

Bijsluiter

 
Zomig Nasal Spray  
Copyright 
1(5) 
140710 
ZOMIG NASAL SPRAY
® 
ZOLMITRIPTAN 5 MG NASAL SPRAY SOLUTION. 

CONSUMER MEDICINE INFORMATION 
WHAT IS IN THIS LEAFLET 
This leaflet answers some of the common questions people ask about 
ZOMIG NASAL SPRAY.  It does 
not contain all the information that is known about 
ZOMIG NASAL SPRAY.   
It does not take the place of talking to your
doctor or pharmacist. 
Your  pharmacist  or  doctor  has  weighed  the  risks  of  you  taking 
ZOMIG  NASAL  SPRAY  against  the 
benefits they expect it will have for you. 
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE,
ASK YOUR PHARMACIST OR DOCTOR. 
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it
again. 
WHAT ZOMIG NASAL SPRAY IS USED FOR 
ZOMIG  NASAL  SPRAY  contains  the  active  ingredient  zolmitriptan.  It  belongs  to  a  group  of medicines 
called serotonin agonists (triptans).   
ZOMIG NASAL SPRAY is used for the acute relief of migraine attacks, with or without what is known as 
‘aura’ or a forewarning of an attack.  This may include visual disturbances such as brilliant flickering 
lights or blurring of vision; or
sensory disturbances such as numbness or weakness of the limbs. 
ZOMIG  NASAL  SPRAY  is  only  suitable  in  patients  who  have  a  stable,  well-established  pattern  of 
symptoms. It should not be used to prevent migraine attacks from
occurring. 
Migraine attacks are thought to be caused by the swelling of blood vessels in the brain. 
ZOMIG NASAL 
SPRAY helps to relieve
the symptoms of a migraine attack by reducing the size of the
blood 
vessels back to normal.   
ZOMIG NASAL SPRAY helps to relieve other symptoms that occur together with a migraine headache, 
such  as  feeling  sick  and  sensi

Productkenmerken

Zomig Nasal Spray Data Sheet 030414
1
NEW ZEALAND DATA SHEET
NAME OF MEDICINE
Z
OMIG
N
ASAL
S
PRAY
Zolmitriptan 5 mg
PRESENTATION
Z
OMIG
N
ASAL
S
PRAY
is an aqueous solution containing 50 mg/mL zolmitriptan, buffered to
pH
5.0. The device delivers a unit dose of 5 mg and is intended for a
single use only.
INDICATIONS
Z
OMIG
N
ASAL
S
PRAY
is indicated for the acute treatment of migraine with or without aura.
Z
OMIG
N
ASAL
S
PRAY
should only be used where there is a clear diagnosis of migraine.
DOSAGE AND ADMINISTRATION
ADULTS (18-65 YEARS OF AGE)
For correct administration of Z
OMIG
N
ASAL
S
PRAY
, see package insert for instructions.
The
recommended
dose
of
Z
OMIG
N
ASAL
S
PRAY
to
treat
a
migraine
attack
is
5
mg
administered as a single dose into one nostril.
Z
OMIG
N
ASAL
S
PRAY
provides a particularly rapid onset of relief of migraine with
significant
efficacy apparent within 15 minutes of dosing.
If there is no response to the first dose, a second dose should not be
taken for the same
attack.
The effect of Z
OMIG
N
ASAL
S
PRAY
is unaffected by co-administered nasal sympathomimetic
decongestants.
USE IN CHILDREN AND ADOLESCENTS (UNDER 18 YEARS OF AGE)
Not to be used in children or adolescents under 18 years of age.
Efficacy has not been
established in children.
USE IN THE ELDERLY (OVER 65 YEARS OF AGE)
Not to be used in those over 65 years of age.
CONTRAINDICATIONS

Z
OMIG
N
ASAL
S
PRAY
must not be used prophylactically

Known hypersensitivity to any component of the product or to
sulphonamides
Zomig Nasal Spray Data Sheet 030414
2

Known hypertension

Previous myocardial infarction

Ischaemic heart disease eg angina

Peripheral vascular disease

Coronary vasospasm/Prinzmetal’s angina

Cardiac arrhythmias (including Wolff-Parkinson-White syndrome)

Hepatic or renal impairment

Epilepsy or history of seizures

Atypical migraine (including hemiplegic, basilar or opthalmoplegic
migraine)

A history of cerebrovascular accident or transient ischaemic attack

Concomitant
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