MAXALT rizatriptan (as benzoate) 10mg wafer blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

rizatriptan benzoate, Quantity: 14.53 mg (Equivalent: rizatriptan, Qty 10 mg)

제공처:

ORGANON PHARMA PTY LTD

약제 형태:

Wafer

구성:

Excipient Ingredients: glycine; mannitol; Gelatin; aspartame; Flavour

관리 경로:

Oral

패키지 단위:

2 wafers, 3 wafers, 6 wafers, 1 wafer (sample pack), 2 wafers (sample pack)

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

Maxalt is indicated for the acute treatment of migraine attacks with or without aura.

제품 요약:

Visual Identification: White to off-white, round wafer with flat or slightly irregular surface, debossed on one side with a modified square, on the other side plain.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

승인 상태:

Registered

승인 날짜:

1999-06-23

환자 정보 전단

MAXALT
®
_Rizatriptan benzoate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start using MAXALT
Wafers. This leaflet answers some
common questions about MAXALT
Wafers. 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
Wafers 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 WAFERS
ARE USED FOR
MAXALT Wafers are used to relieve
the headache pain and other
symptoms of migraine attacks.
MAXALT Wafers do 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, alcohol (especially red
wine)
•
stress, anger, worry
•
changes in routine, for example,
under or over sleeping, missing a
meal, change in diet
•
bright light or loud noises
•
hormonal changes in women, for
example, during menstrual
periods
If you understand what triggers your
attacks, you may be able to prevent
m

제품 특성 요약

MK0462-AUS-2017-014577
Page 1 of 15
AUSTRALIAN PRODUCT INFORMATION
MAXALT
® (RIZATRIPTAN BENZOATE)
1
NAME OF THE MEDICINE
Rizatriptan benzoate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rizatriptan benzoate is a white to off-white, crystalline solid.
Rizatriptan benzoate is soluble in
water at about 42 mg per mL (expressed as free base) at 25°C.
Each lyophilised wafer contains either 7.265 mg or 14.53 mg of
rizatriptan benzoate
(corresponding to 5 mg or 10 mg of rizatriptan, respectively).
List of excipients with known effect: mannitol, aspartame
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
5 mg wafer - White to off-white round wafer with a flat or slightly
irregular surface.
10 mg wafer - White to off-white round wafer with a flat or slightly
irregular surface.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MAXALT is indicated for the acute treatment of migraine attacks with
or without aura.
4.2
DOSE AND METHOD OF ADMINISTRATION
MAXALT wafers are rapidly dissolving wafers. Administration with
liquid is not necessary.
The wafer is packaged in a blister within an outer aluminium sachet
(pouch). Patients should
be instructed not to remove the blister from the outer sachet until
just prior to dosing. The
blister pack should then be peeled open with dry hands and the wafer
placed on the tongue,
where it will dissolve and be swallowed with the saliva.
The recommended dose is 10 mg. Clinical experience has shown that this
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.
_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