Maxalt Melt

البلد: نيوزيلاندا

اللغة: الإنجليزية

المصدر: Medsafe (Medicines Safety Authority)

العنصر النشط:

Rizatriptan benzoate 14.53mg equivalent to 10 mg Rizatriptan

متاح من:

Merck Sharp & Dohme (New Zealand) Limited

INN (الاسم الدولي):

Rizatriptan benzoate 14.53 mg (Equiv to 10 mg Rizatriptan)

جرعة:

10 mg

الشكل الصيدلاني:

Wafer

تركيب:

Active: Rizatriptan benzoate 14.53mg equivalent to 10 mg Rizatriptan Excipient: Aspartame Gelatin Glycine Mannitol Mentha x piperita Purified water

الوحدات في الحزمة:

Blister pack, 2 wafers

الفئة:

Prescription

نوع الوصفة الطبية :

Prescription

المصنعة من قبل:

MSD International GmbH (Ireland)

الخصائص العلاجية:

For the acute treatment of migraine attacks with or without aura.

ملخص المنتج:

Package - Contents - Shelf Life: Blister pack, - 2 wafers - 36 months from date of manufacture stored at or below 30°C - Blister pack, - 3 wafers - 36 months from date of manufacture stored at or below 30°C - Blister pack, - 6 wafers - 36 months from date of manufacture stored at or below 30°C

تاريخ الترخيص:

1997-07-10

نشرة المعلومات

New Zealand Consumer Medicine Information 
MAXALT
®
/MAXALT
®
 MELT WAFERS 
1 
MAXALT
®

_rizatriptan benzoate _
5 mg wafer (Not currently marketed in New Zealand) 

MAXALT
®
 MELT 
_rizatriptan benzoate _
10 mg wafer 
WHAT IS IN THIS LEAFLET 
Please read this leaflet carefully before you start using
MAXALT/MAXALT MELT (wafers). 
This leaflet answers some common questions about MAXALT/MAXALT
MELT.  It does not 
contain all 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 
MAXALT/MAXALT MELT against the benefits they expect it will 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 MAXALT/MAXALT MELT IS USED FOR 
MAXALT/MAXALT MELT is used to relieve the headache pain and other
symptoms of 
migraine attacks.  MAXALT/MAXALT MELT does not work for other types
of headaches. 
Migraine is an intense, throbbing, typically one-sided headache.
 It often includes nausea, 
vomiting, sensitivity to light, and sensitivity to sound.  Some
people may have visual 
symptoms before the headache, called an aura.  An aura can include
flashing lights or wavy 
lines. 
Migraine attacks last anything from two hours to two days and they
can return frequently.  
The severity and frequency of migraine attacks may vary. 
Migraine occurs in about one out of every 10 people.  It is three
times more common in 
women than men.  Six out of ten migraine sufferers have their
first attack before the age of 
20. 
There is no single cause of migraine.  It tends to run in families.
 Certain things, singly or in 
combination, can trigger migraine attacks in some people.  Some of
these triggers are: 
 
certain foods or drinks, for example, cheese and other dairy
products, chocolate, citrus 
fruit, caffeine, al

خصائص المنتج

MAXALT Wafer DS A130227 v6 (WPC-MK0462-T-R-062012) 
Page 1 

NEW ZEALAND DATA SHEET 

MAXALT
®

_(rizatriptan benzoate, MSD) _
5 mg wafer 

MAXALT
®
 MELT 
_(rizatriptan benzoate, MSD) _
10 mg wafer 

PRESENTATIONS 
The 5 mg MAXALT wafer is a white to off-white round disc with a flat
or a slightly irregular 
surface debossed on one side with a modified triangle and plain on the
other.  Diameter 10-
11.5 mm (Not currently marketed in New Zealand). 
The 10 mg MAXALT MELT wafer is a white to off-white round disc with a
flat or a slightly 
irregular surface debossed on one side with a modified square and
plain on the other.  
Diameter 12-13.8 mm. 
Wafer cannot be halved. 

INDICATIONS 
MAXALT/MAXALT MELT is indicated for the acute treatment of migraine
attacks with or 
without aura. 

DOSAGE AND ADMINISTRATION 
Clinical experience has shown that the 10 mg MAXALT MELT dose
provides the optimal 
clinical benefit. 
Onset of relief (i.e., reduction of headache pain to mild or none)
can occur within 30 minutes 
after dosing. 
In clinical trials MAXALT was administered without regard to food. 
Do not halve wafer.   

RE-DOSING 
Doses should be separated by at least 2 hours; no more than 30 mg
should be taken in any 
24-hour period. 

_FOR HEADACHE RECURRENCE WITHIN 24 HOURS _
If headache returns after relief of the initial attack, further doses
may be taken.  The above 
dosing limits should be observed. 

_AFTER NON-RESPONSE _
The effectiveness of a second dose for treatment of the same attack,
when an initial dose is 
ineffective, has not been examined in controlled trials. 
Clinical studies have shown that patients who do not respond to
treatment of an attack are 
still likely to respond to treatment for subsequent attacks. 
MAXALT Wafer DS A130227 v6 (WPC-MK0462-T-R-062012) 
Page 2 

PATIENTS RECEIVING PROPRANOLOL 
In patients receiving propranolol, a 5 mg dose of MAXALT should be
used, up to a maximum 
of 3 doses in a