APO-TERIFLUNOMIDE teriflunomide 14 mg tablet blister pack

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

teriflunomide, Quantity: 14 mg

Dostupné s:

Dr Reddys Laboratories Australia Pty Ltd

Léková forma:

Tablet

Složení:

Excipient Ingredients: maize starch; lactose monohydrate; sodium starch glycollate; hyprolose; silicon dioxide; magnesium stearate; titanium dioxide; hypromellose; iron oxide yellow; macrogol 6000; indigo carmine aluminium lake

Podání:

Oral

Jednotky v balení:

84, 5, 14, 28, 10

Druh předpisu:

(S4) Prescription Only Medicine

Terapeutické indikace:

APO-TERIFLUNOMIDE is indicated for the treatment of patients with relapsing forms of Multiple Sclerosis to reduce the frequency of clinical relapses and to delay the progression of physical disability.

Přehled produktů:

Visual Identification: Blue coloured, pentagonal shaped, biconvex, film coated tablets, debossed with "14" on one side and "T" on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Stav Autorizace:

Registered

Datum autorizace:

2019-04-08

Informace pro uživatele

APO-TERIFLUNOMIDE
1
APO-TERIFLUNOMIDE
_Teriflunomide _
CONSUMER MEDICINE INFORMATION
FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
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 THIS MEDICINE IS
USED FOR
Teriflunomide is used to treat
relapsing forms of multiple sclerosis
(MS).
The cause of MS is not yet known.
MS affects the central nervous
system (CNS) – the brain and spinal
cord. In MS, the body's immune
system reacts against its own myelin
(the 'insulation' or the protective
sheath surrounding nerve fibres).
With relapsing forms of MS, people
can have repeated attacks or relapses
of inflammation of the CNS from
time to time. Symptoms vary from
patient to patient and may include
blurred vision, weakness in the legs
or arms, or loss of control of bowel
or bladder function. These are
followed by periods of recovery.
Teriflunomide works by selectively
interfering with the ability of white
blood cells (lymphocytes) to produce
the disease response and nerve
damage that ultimately leads to
relapses.
Teriflunomide has been shown to
reduce or decrease the number of
relapses and slow down the
progression of physical disability in
patients with relapsing forms of MS.
Although it is not a cure, patients
treated with teriflunomide generally
find they will have fewer relapses.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is only available with
a doctor's prescription.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT

Charakteristika produktu

Page 1
PRODUCT INFORMATION
APO-TERIFLUNOMIDE (TERIFLUNOMIDE)
1
NAME OF THE MEDICINE
Teriflunomide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Teriflunomide, is an oral
_de novo _
pyrimidine synthesis inhibitor of the dihydroorotate
dehydrogenase (DHO-DH) enzyme.
Teriflunomide is a white to almost white powder that is sparingly
soluble in acetone, slightly
soluble in polyethylene glycol and ethanol, very slightly soluble in
isopropanol and practically
insoluble in water. Teriflunomide has a pKa of 3.1 at room temperature
and its aqueous solubility
is pH dependent and decreases with lowering pH. Teriflunomide is Class
2 in the
Biopharmaceutics Classification System.
Teriflunomide is formulated as film-coated tablets for oral
administration. Each tablet contains
14
mg of teriflunomide.
Excipients with known effect: Each tablet contains 83.4 mg of lactose
monohydrate. For the full
list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
APO-TERIFLUNOMIDE is available as a blue coloured, pentagonal shaped,
biconvex film-coated
tablet with “14” debossed on one side and “T” on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of patients with relapsing forms of Multiple
Sclerosis to reduce the frequency of
clinical relapses and to delay the progression of physical disability.
Page 2
4.2
DOSE
AND
METHOD
OF
ADMINISTRATION
The recommended dose of teriflunomide is 14mg orally once daily.
Teriflunomide can be taken with
or without food.
SPECIAL POPULATIONS
_CHILDREN_
_ _
The safety and efficacy of teriflunomide in paediatric patients with
MS below the age of 18 years has
not yet been established.
_ELDERLY_
_ _
Clinical studies of teriflunomide did not include patients over 65
years old. Teriflunomide should be
used with caution in patients aged over 65 years.
_HEPATIC IMPAIRMENT_
_ _
No dosage adjustment is necessary for patients with mild or moderate
hepatic impairment.
Teriflunomide is contraindicated in patients with severe hepatic
impairment (see Precautions).
_RE