MEZAVANT mesalazine 1.2 g gastro-resistant, prolonged release tablet blister pack

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

mesalazine, Quantity: 1200 mg

Доступна с:

Takeda Pharmaceuticals Australia Pty Ltd

ИНН (Международная Имя):

Mesalazine

Фармацевтическая форма:

Tablet, modified release

состав:

Excipient Ingredients: methacrylic acid copolymer; purified talc; silicon dioxide; sodium starch glycollate; stearic acid; iron oxide red; carmellose sodium; Carnauba Wax; magnesium stearate; titanium dioxide; macrogol 6000; triethyl citrate

Администрация маршрут:

Oral

Штук в упаковке:

12 tablets, 120 tablets, 60 tablets

Тип рецепта:

(S4) Prescription Only Medicine

Терапевтические показания :

For the induction and maintenance of remission in patients with mild to moderate, active ulcerative colitis.

Обзор продуктов:

Visual Identification: Red-brown, ellipsoidal, film-coated tablet, S476 debossed on one side; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Статус Авторизация:

Registered

Дата Авторизация:

2009-09-25

тонкая брошюра

MEZAVANT
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING MEZAVANT?
MEZAVANT contains the active ingredient mesalazine. MEZAVANT is used
for the treatment of ulcerative colitis.
For more information, see Section 1. Why am I using MEZAVANT? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE MEZAVANT?
Do not use if you have ever had an allergic reaction to MEZAVANT or
any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become pregnant
or are breastfeeding.
For more information, see Section 2. What should I know before I use
MEZAVANT? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with MEZAVANT and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE MEZAVANT?
•
Your doctor will tell you what dose to take each day.
•
Take your tablets with or without food at the same time each day. The
tablets must be swallowed whole and must not be
crushed or chewed. Follow all directions given to you by your
pharmacist or doctor carefully.
More instructions can be found in Section 4. How do I use MEZAVANT? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING MEZAVANT?
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist you visit that you are using MEZAVANT. If
you are pregnant or intend to
become pregnant while using this medicine, tell the doctor
immediately.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly or change the dosage without
checking with your doctor.
DRIVING
OR USING
MACHINES
•
MEZAVANT is unlikely to have any effect on your ability to drive or
use machines.
LOOKING AFTER
YOUR MEDICINE
•
Store MEZAVANT in a cool dry place where the temperature is below
25°C.
For more information,

Характеристики продукта

MEZAVANT PI V4.0(CCDS V24)
1
AUSTRALIAN PRODUCT INFORMATION
MEZAVANT
® (MESALAZINE) PROLONGED RELEASE TABLET
1
NAME
OF
THE
MEDICINE
Mesalazine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
MEZAVANT contains 1.2 g of the active ingredient mesalazine.
The MEZAVANT tablet contains a core of mesalazine (5-aminosalicylic
acid), 1.2 g,
formulated in a multi-matrix system. This system is coated with
methacrylic acid copolymers,
Type A and Type B, which are designed to dissolve at approximately pH
7. The matrix of
lipophilic and hydrophilic excipients facilitates the extended
delivery of effective
concentrations of mesalazine through the entire colon with limited
systemic absorption.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Gastro-resistant, prolonged release tablets.
APPEARANCE
The tablets are presented as red-brown, ellipsoidal, film-coated
tablets, debossed on one side
with S476.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the induction and maintenance of remission in patients with mild
to moderate, active
ulcerative colitis.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
MEZAVANT is intended for once daily, oral administration.
ADULTS, INCLUDING THE ELDERLY (>65 YEARS)
For induction of remission: 2.4 to 4.8 g (two to four tablets) should
be taken once daily.
For maintenance of remission: 2.4 g (two tablets) should be taken once
daily.
MEZAVANT PI V4.0(CCDS V24)
2
CHILDREN AND ADOLESCENTS
MEZAVANT is not recommended for use in children below the age of 18
years due to a lack
of data on safety and efficacy.
METHOD OF ADMINISTRATION
For oral administration. MEZAVANT tablets must not be crushed or
chewed and should be
swallowed whole with or without food.
DOSAGE ADJUSTMENT
Specific studies have not been performed to investigate MEZAVANT in
patients with hepatic
or renal impairment, dialysis or concomitant disease.
MONITORING ADVICE
The highest dose of 4.8 g/day is recommended for patients not
responding to lower doses of
mesalazine. When using the highest dose (4.