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

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

fingolimod hydrochloride, Quantity: 0.56 mg (Equivalent: fingolimod, Qty 0.5 mg)

Dostopno od:

Pharmacor Pty Ltd

Farmacevtska oblika:

Capsule, hard

Sestava:

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

Pot uporabe:

Oral

Enote v paketu:

28, 7, 84

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

PHARMACOR 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.

Povzetek izdelek:

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

Status dovoljenje:

Registered

Datum dovoljenje:

2020-08-18

Navodilo za uporabo

*0.25 MG STRENGTH IS AVAILABLE IN OTHER BRANDS.
PHARMACORFINGOLIMOD
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.
PHARMACOR FINGOLIMOD*
_Fingolimod hydrochloride _
Consumer Medicine Information (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
PHARMACOR 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
PHARMACOR 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 PHARMACOR
FINGOLIMOD IS USED FOR
PHARMACOR Fingolimod
contains the active substance
fingolimod, which belongs to a
group of medicines known as
sphingosine 1-phosphate (S1-P)
receptor modulators.
PHARMACOR 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 t

Lastnosti izdelka

*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
PHARMACOR FINGOLIMOD CAPSULES*
(Fingolimod hydrochloride)
1.
NAME OF THE MEDICINE
The active ingredient of PHARMACOR Fingolimod is fingolimod
hydrochloride.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
PHARMACOR
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
PHARMACOR 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
PHARMACOR 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 PHARMACOR 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.
PHARMACOR 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 PHARMACOR Fing