AKM FINGOLIMOD fingolimod (as hydrochloride) 0.5 mg capsule blister pack

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

active_ingredient:

fingolimod hydrochloride, Quantity: 0.56 mg (Equivalent: fingolimod, Qty mg)

MAH:

Pharmacor Pty Ltd

pharmaceutical_form:

Capsule, hard

composition:

Excipient Ingredients: magnesium stearate; calcium hydrogen phosphate; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide; iron oxide yellow; titanium dioxide; Gelatin

administration_route:

Oral

units_in_package:

28, 84, 7

prescription_type:

(S4) Prescription Only Medicine

therapeutic_indication:

AKM Fingolimod is indicated for the treatment of adult and paediatric patients of 10 years of age and above with relapsing forms of multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

leaflet_short:

Visual Identification: White to off- white powder filled in size 4 hard gelatin capsules, with a white opaque body with two radial band imprinted with yellow ink and bright yellow cap imprinted with FIG 0.5 mg with black ink.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

authorization_status:

Registered

authorization_date:

2020-08-18

PIL

*0.25 MG STRENGTH IS AVAILABLE IN OTHER BRANDS.
AKM FINGOLIMOD
Ver: 03
1
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
You can report side effects to your
doctor, or directly at www.tga.gov.au/reporting-problems.
AKM FINGOLIMOD*
_Fingolimod hydrochloride _
Consumer Medicine Information (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about AKM
Fingolimod.
It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on
the final page. More recent
information on the medicine may
be available.
YOU SHOULD ENSURE THAT YOU
SPEAK TO YOUR PHARMACIST OR
DOCTOR TO OBTAIN THE MOST UP TO
DATE INFORMATION ON THE
MEDICINE.
Any updates may contain
important information about the
medicine and its use of which you
should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the benefits he/she expects AKM
Fingolimod will provide to you
against the risks in deciding to
prescribe this medicine for you.
IF YOU HAVE ANY CONCERNS ABOUT
THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT AKM FINGOLIMOD
IS USED FOR
AKM Fingolimod contains the
active substance fingolimod,
which belongs to a group of
medicines known as sphingosine
1-phosphate (S1-P) receptor
modulators. AKM Fingolimod can
alter the way the body's immune
system works and is used in
adults, children and adolescents
(10 years of age and above) to
treat relapsing forms of multiple
sclerosis (MS). MS is a long-term
condition that affects the central
nervous system (CNS),
particularly how the brain and
spinal cord work. In MS,
inflammation destroys the
protective cover around the nerves
(called myelin) and stops the
nerves from working properly.
The cause of MS is unknown but
it is thought that an abnormal
response by the b

SPC

*0.25 MG STRENGTH IS AVAILABLE IN OTHER BRANDS.
PHARMACOR FINGOLIMOD
Ver: 03
1
This medicinal product is subject to additional monitoring in
Australia. This will allow
quick identification of new safety information. Healthcare
professionals are asked to
report any suspected adverse events at
www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION
AKM FINGOLIMOD CAPSULES*
(Fingolimod hydrochloride)
1.
NAME OF THE MEDICINE
The active ingredient of AKM Fingolimod is fingolimod hydrochloride.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each AKM Fingolimod capsule contains 0.56 mg fingolimod hydrochloride
(equivalent to
0.5 mg fingolimod)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
AKM Fingolimod 0.5 mg capsule: White to off- white powder filled in
size 4 hard gelatin
capsules, with a white opaque body with two radial band imprinted with
yellow ink and bright
yellow cap imprinted with "FIG 0.5 mg" with black ink.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
AKM Fingolimod is indicated for the treatment of adult and paediatric
patients of 10 years of
age and above with relapsing forms of multiple sclerosis to reduce the
frequency of relapses
and to delay the progression of disability.
4.2 DOSE AND METHOD OF ADMINISTRATION
In adults the recommended dose of AKM Fingolimod is one 0.5 mg capsule
taken orally once
daily.
In paediatric patients (10 years of age and above), the recommended
dose is dependent on body
weight:
•
_Paediatric patients with body weight ≤ 40 kg: one 0.25 mg capsule
daily taken orally. _
•
_Paediatric patients with body weight > 40 kg: one 0.5 mg capsule
daily taken orally. _
PHARMACOR FINGOLIMOD
Ver: 04
2
Paediatric patients who start on 0.25 mg capsules and subsequently
reach a stable body weight
above 40 kg should be switched to 0.5 mg capsules.
AKM Fingolimod can be taken with or without food. If a dose is missed,
treatment should be
continued with the next dose as planned.
On initiation of AKM Fingolimod treatment, after the first dose, it is
re