AKM DIMETHYL FUMARATE dimethyl fumarate 240 mg delayed release capsule blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

dimethyl fumarate, Quantity: 240 mg

제공처:

Pharmacor Pty Ltd

약제 형태:

Capsule, enteric

구성:

Excipient Ingredients: croscarmellose sodium; triethyl citrate; silicified microcrystalline cellulose; methacrylic acid copolymer; magnesium stearate; colloidal anhydrous silica; purified talc; titanium dioxide; indigo carmine; purified water; iron oxide yellow; Gelatin; polysorbate 80; sodium lauryl sulfate

관리 경로:

Oral

패키지 단위:

56's, 112's, 14's, 70's

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

It is indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

제품 요약:

Visual Identification: White off white, enteric coated round shaped mini tablets filled in size "0" hard gelatin capsule, opaque green cap printed with "DMF" and opaque green body with "240" in black ink.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius

승인 상태:

Registered

승인 날짜:

2021-07-14

환자 정보 전단

Akm Dimethyl Fumarate (Version-02)
Page 1
AKM DIMETHYL FUMARATE
_ DIMETHYL FUMARATE _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about Akm
Dimethyl Fumarate. It does not
contain all the available
information. It does not take
the place of talking to your
doctor or pharmacist.
This leaflet was last updated
on the date at the end of this
leaflet.
SPEAK TO YOUR PHARMACIST OR
DOCTOR TO OBTAIN THE MOST UP
TO DATE INFORMATION ON THIS
MEDICINE.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
Akm Dimethyl fumarate
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 AKM DIMETHYL
FUMARATE IS USED FOR
Akm Dimethyl Fumarate is
used to treat relapsing multiple
sclerosis (MS).
Akm Dimethyl Fumarate slows
down the progression of
physical disability in people
with relapsing forms of MS
and decreases the number of
flare ups (relapses).
Some people feel better when
they start to take Akm
Dimethyl Fumarate. However
Akm Dimethyl Fumarate
cannot repair damage that has
already been caused by MS.
When you start Akm Dimethyl
Fumarate you might not notice
an improvement, but Akm
Dimethyl Fumarate may still
be working to help prevent
your MS from becoming worse.
The cause of MS is not yet
known, MS affects the brain
and spinal cord. In MS, the
body's immune system reacts
against its own myelin (the
'insulation' surrounding nerve
fibres).In relapsing forms of
MS, people have
'exacerbations' from time to
time (e.g. blurred vision,
weakness in the legs or arms,
or loss of control of bowel or
bladder function).
They are followed by periods
of recovery.
Recovery may be complete or
incomplete. If it is incomplete
there is 'progression of
disability'.
Akm Dimethyl Fumarate
contains the active ingredient
dimethyl fumarate. Dimethyl
fumarate decreases the
inflammation in your brain that
is cau

제품 특성 요약

Akm Dimethyl Fumarate (Version-02) Page 1
AUSTRALIAN PRODUCT INFORMATION
AKM DIMETHYL FUMARATE (DIMETHYL FUMARATE) DELAYED RELEASE CAPSULES
1.
NAME OF THE MEDICINE
Dimethyl fumarate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Akm Dimethyl Fumarate 120 mg Delayed Release Capsules
Each capsule contains 120 mg of Dimethyl fumarate
Akm Dimethyl Fumarate 240 mg Delayed Release Capsules
Each capsule contains 240 mg of Dimethyl fumarate
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Capsule, Delayed release
Akm Dimethyl Fumarate 120 mg Delayed Release Capsules-
White to off white, enteric coated round shaped mini tablets filled in
size "1" hard gelatin
capsules, Opaque Green cap printed with "DMF" and Opaque white body
printed with" 120" in
black ink.
Akm Dimethyl Fumarate 240 mg Delayed Release Capsules-
White to off white, enteric coated round shaped mini tablets filled in
size "0" hard gelatin
capsules, Opaque Green cap printed with "DMF" and Opaque green body
printed with "240" in
black ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Akm Dimethyl Fumarate is indicated in patients with relapsing multiple
sclerosis to reduce the
frequency of relapses and to delay the progression of disability.
4.2
DOSE AND METHOD OF ADMINISTRATION
The starting dose for Akm Dimethyl Fumarate is 120 mg twice a day
orally. After 7 days,
increase to the recommended dose of 240 mg twice a day orally.
Akm Dimethyl Fumarate (Version-02) Page 2
The capsule or its contents should not be crushed, divided or
dissolved as the enteric coating of
the microtablets prevents irritant effects on the gut.
Temporary dose reduction to 120 mg twice a day may reduce the
occurrence of flushing and
gastrointestinal (GI) side effects. Within 1 month, the recommended
dose of 240 mg twice a
day orally should be resumed.
Akm Dimethyl Fumarate can be taken with or without food. For those
patients who may
experience gastrointestinal or flushing side effects, taking Akm
Dimethyl Fumarate with food
may improve tol