FINGOLIMOD-TEVA fingolimod (as hydrochloride) 0.5 mg capsule blister pack

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

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

Dostępny od:

Teva Pharma Australia Pty Ltd

Forma farmaceutyczna:

Capsule, hard

Skład:

Excipient Ingredients: iron oxide yellow; titanium dioxide; Gelatin; sodium lauryl sulfate; pregelatinised maize starch; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Droga podania:

Oral

Sztuk w opakowaniu:

28 capsules, 30 capsules, 84 capsules, 7 capsules

Typ recepty:

(S4) Prescription Only Medicine

Wskazania:

FINGOLIMOD-TEVA 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.

Podsumowanie produktu:

Visual Identification: Size 4 capsule, imprinted in black with 'TV 7820' on the yellow capsule cap and 'TV 7820' on the white opaque capsule body.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Status autoryzacji:

Registered

Data autoryzacji:

2023-01-16

Ulotka dla pacjenta

FINGOLIMOD-TEVA
F
I
N
G
O
L
I
M
O
D
-
T
E
V
A
v
1
.
0
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
▼
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I USING FINGOLIMOD-TEVA?
FINGOLIMOD-TEVA contains the active ingredient fingolimod
hydrochloride. FINGOLIMOD-TEVA is used in adults, children and
adolescents (10 years of age and above) to treat relapsing forms of
multiple sclerosis (MS).
For more information, see Section 1. Why am I using FINGOLIMOD-TEVA?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE FINGOLIMOD-TEVA?
Do not use if you have ever had an allergic reaction to
FINGOLIMOD-TEVA or any of the ingredients listed at the end of the
CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
FINGOLIMOD-TEVA? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with FINGOLIMOD-TEVA and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE FINGOLIMOD-TEVA?
•
The usual dose for adults and children weighing over 40 kg is one
capsule per day (0.5 mg of fingolimod).
•
The usual dose for children weighing 40 kg or less is one 0.25 mg
capsule per day.
More instructions can be found in Section 4. How do I use
FINGOLIMOD-TEVA? in the full CMI.
*0.25 mg capsules are available in other brands
5.
WHAT SHOULD I KNOW WHILE USING FINGOLIMOD-TEVA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
FINGOLIMOD-TEVA.
•
Avoid becoming pregnant while taking FINGOLIMOD-TEVA
•
Tell your doctor about any changes in your vision
THINGS YOU
SHOULD NOT DO
•
You should not receive certain types of vaccin

Charakterystyka produktu

Fingolimod-Teva v1.0
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-TEVA
(FINGOLIMOD) CAPSULES
1
NAME OF THE MEDICINE
Fingolimod.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each FINGOLIMOD-TEVA capsule contains 0.56 mg fingolimod hydrochloride
(equivalent to 0.5 mg
fingolimod).
Excipient of known effect: Gelatin may contain residual sulfites.
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
FINGOLIMOD-TEVA 0.5 mg capsule: A hard gelatin capsule, size 4, filled
with white to off-white
powder, imprinted in black, with “TV 7820” on the yellow capsule
cap and “TV 7820” on the white
opaque capsule body.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
FINGOLIMOD-TEVA 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
In adults the recommended dose of FINGOLIMOD-TEVA 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. _
Fingolimod-Teva v1.0
2
_*0.25 MG STRENGTH IS AVAILABLE IN OTHER BRANDS _
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.
FINGOLIMOD-TEVA 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 FINGOLIMOD-TEVA treatment, after the first dose, it
is recommend