IMULATE mycophenolate mofetil 250mg capsule blister pack

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

mycophenolate mofetil, Quantity: 250 mg

Доступна с:

Arrotex Pharmaceuticals Pty Ltd

ИНН (Международная Имя):

Mycophenolate mofetil

Фармацевтическая форма:

Capsule, hard

состав:

Excipient Ingredients: erythrosine; Gelatin; povidone; microcrystalline cellulose; purified water; sodium lauryl sulfate; titanium dioxide; croscarmellose sodium; magnesium stearate; iron oxide yellow; butan-1-ol; Shellac; industrial methylated spirit; iron oxide black; lecithin; xanthan gum; glyceryl monostearate; benzoic acid; methylcellulose; simethicone; glyceryl distearate; PEG-10 stearate; sorbic acid; dimeticone 5000

Администрация маршрут:

Oral

Штук в упаковке:

300, 100

Тип рецепта:

(S4) Prescription Only Medicine

Терапевтические показания :

Imulate is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. Imulate is indicated for the prophylaxis of organ rejection in paediatric patients with a body surface area of greater than or equal to 1.25 meters square receiving allogeneic renal transplants (refer DOSAGE and ADMINISTRATION section).

Обзор продуктов:

Visual Identification: White to off white blend of Mycophenolate Mofetil filled in size 1 hard gelatin capsules with ivory Cap and ivory body printed 'SAL' on cap & '726' on body in black ink; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Статус Авторизация:

Licence status A

Дата Авторизация:

2011-04-13

тонкая брошюра

IMULATE – Consumer Medicine Information
Page 1 of 4
IMULATE CAPSULES AND TABLETS
_mycophenolate mofetil _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Imulate capsules
and tablets.
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 Imulate
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 IMULATE IS USED FOR
Imulate contains the active
ingredient mycophenolate mofetil.
Imulate belongs to a group of
medicines called
immunosuppressants.
Immunosuppressants are used to
prevent rejection of transplanted
organs, and work by stopping your
immune system from reacting to the
transplanted organ.
Imulate may be used together with
other medicines known as
cyclosporin and corticosteroids.
Your doctor, however, may have
prescribed Imulate for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IMULATE HAS
BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
Imulate is not addictive.
BEFORE YOU TAKE IT
_ _
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE IMULATE IF:
1. YOU HAVE HAD AN ALLERGIC
REACTION TO IMULATE OR ANY
INGREDIENTS LISTED AT THE END
OF THIS LEAFLET.
Symptoms of an allergic reaction
may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue
or other parts of the body

rash, itching, hives on the skin.
2.
THE PACKAGE IS TORN OR SHOWS
SIGNS OF TAMPERING.
3.
THE EXPIRY DATE (EXP) PRINTED
ON THE PACK HAS PASSED. If you
take this medicine after the
expiry date has passed, it may
not work as well.
IF YOU ARE NOT SURE IF YOU SHOULD
BE TAKING IMULATE, TALK TO YOUR
DOCTOR.
_BEFORE YOU START TO TAKE IT _
TELL YOUR DOCTOR IF:
1.
YOU ARE PREGNANT OR

Характеристики продукта

IMULATE – Product Information
Page 1 of 26
PRODUCT INFORMATION
IMULATE
NAME OF THE MEDICINE
mycophenolate mofetil
CAS-115007-34-6
Mycophenolate mofetil is the 2-morpholinoethyl ester of mycophenolic
acid. The chemical
name for mycophenolate mofetil is 2-morpholinoethyl(_E_)-6-(1,
3-dihydro-4-hydroxy-6-
methoxy-7-methyl-3-oxo-5-isobenzofuranyl) -4-methyl4-hexenoate. It has
an empirical
formula of C
23
H
31
NO
7
and a molecular weight of 433.50.
DESCRIPTION
Mycophenolate mofetil is a white to off-white crystalline powder. It
is freely soluble in
dimethyl sulfoxide, tetrahydrofuran, acetone, acetonitrile,
dichloromethane, and ethyl acetate;
soluble in methanol and propylene carbonate; sparingly soluble in
anhydrous ethanol; slightly
soluble in 2-propanol, diethyl ether, and very slightly soluble in
hexane. It is practically
insoluble in water (43 µg/mL at pH 7.4); the solubility increases in
acidic medium (4.27
mg/mL at pH 3.6).
Imulate tablet is available as a mauve-coloured, capsule shaped
film-coated tablet containing
500 mg of mycophenolate mofetil with the excipients: microcrystalline
cellulose,
croscarmellose sodium, povidone, magnesium stearate, hypromellose,
titanium dioxide,
macrogol 400, iron oxide red, allura red AC and brilliant blue FCF.
Imulate capsule is available as an ivory coloured hard gelatin capsule
contains 250 mg
mycophenolate mofetil with the excipients: microcrystalline cellulose,
croscarmellose
sodium, povidone and magnesium stearate. The capsule shell contains
gelatin, water –
purified, sodium lauryl sulphate, iron oxide yellow, allura red AC,
titanium dioxide and
Opacode black S-1-8152HV ink (ARTG no. 1560).
PHARMACOLOGY
MECHANISM OF ACTION
Mycophenolic acid (MPA) is a potent, selective, uncompetitive and
reversible inhibitor of
inosine monophosphate dehydrogenase (IMPDH) which inhibits the _de
novo_ pathway of
IMULATE – Product Information
Page 2 of 26
guanosine nucleotide synthesis without incorporation into DNA.
Based on Chinese hamster inosine-5’-monophosphate dehydrongenase