FINGOLIMOD SUN fingolimod (as hydrochloride) 500 microgram capsule blister pack

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

fingolimod hydrochloride, Quantity: 560 microgram (Equivalent: fingolimod, Qty 500 microgram)

Dostupné z:

Sun Pharma ANZ Pty Ltd

Forma lieku:

Capsule, hard

Zloženie:

Excipient Ingredients: polacrilin potassium; crospovidone; colloidal anhydrous silica; magnesium stearate; Gelatin; sodium lauryl sulfate; titanium dioxide; iron oxide yellow; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Spôsob podávania:

Oral

Počet v balení:

84 capsules, 28 capsules, 7 capsules

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

FINGOLIMOD SUN 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.

Prehľad produktov:

Visual Identification: Hard gelatin, size 4 yellow cap & white body, axially imprinted with 064 on cap & body in black ink, filled with white to off-white granular powder.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Stav Autorizácia:

Registered

Dátum Autorizácia:

2020-09-09

Príbalový leták


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.
FINGOLIMOD SUN
_Fingolimod hydrochloride _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Fingolimod Sun.
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
Fingolimod Sun 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 FINGOLIMOD SUN IS
USED FOR
Fingolimod Sun contains the active
substance fingolimod, which belongs to
a group of medicines known as
sphingosine 1-phosphate (S1-P)
receptor modulators. Fingolimod Sun
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
remitting 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 body's immune system plays an
important part in the process which
da

Súhrn charakteristických

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 – FINGOLIMOD SUN
(FINGOLIMOD) CAPSULES
1
NAME OF THE MEDICINE
The active ingredient of
FINGOLIMOD SUN
is fingolimod.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fingolimod hydrochloride is a white to almost white crystalline powder
which is freely
soluble in water. Fingolimod is a base with pKa of 7.82. Therefore, it
has high solubility at
low
pH
and
very
low
solubility
at
high
pH
(e.g.
<
0.01
mg/mL
at
pH
6.8).
Relevant
distribution coefficients are 22.3 in
_n_
-Octanol/water and 1290 in
_n_
-Octanol/hydrochloric
acid 0.1N.
0.5
mg
hard
capsules:
Each
FINGOLIMOD
SUN
capsule
contains
0.56
mg
fingolimod
hydrochloride (equivalent to 0.5 mg fingolimod).
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
FINGOLIMOD SUN 0.5 mg capsule: hard gelatin capsules, size '4' yellow
cap and white body,
axially imprinted with '064' on cap and on body in black ink, filled
with white to off-white
granular powder.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
FINGOLIMOD SUN 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
D
OSE AND METHOD OF ADMINISTRATION
_*_
_Fingolimod SUN is unavailable in capsule strengths below 500
micrograms and therefore _
_only appropriate for use in paediatric patients weighing ≥ 40 kg.
For paediatric patients _
_requiring treatment with lower strengths of fingolimod, other brands
are available._
In adults the recommended dose of FINGOLIMOD SUN 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 pa