Teri-EM teriflunomide 14 mg tablet blister pack

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

teriflunomide, Quantity: 14 mg

थमां उपलब्ध:

Emcure Pharmaceuticals Pty Ltd

फार्मास्यूटिकल फॉर्म:

Tablet, film coated

रचना:

Excipient Ingredients: hyprolose; maize starch; microcrystalline cellulose; sodium starch glycollate type A; silicon dioxide; lactose monohydrate; magnesium stearate; titanium dioxide; macrogol 8000; hypromellose; purified talc; indigo carmine aluminium lake

प्रशासन का मार्ग:

Oral

पैकेज में यूनिट:

28 tablets

प्रिस्क्रिप्शन प्रकार:

(S4) Prescription Only Medicine

चिकित्सीय संकेत:

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.

उत्पाद समीक्षा:

Visual Identification: Light blue colored, round, biconvex, film coated tablet, debossed with 'HP' on one side and '555' on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

प्राधिकरण का दर्जा:

Registered

प्राधिकरण की तारीख:

2020-05-27

सूचना पत्रक

Teri-EM
®
1
TERI-EM
®
_Teriflunomide _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Teri-EM.
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 Teri-EM
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 TERI-EM IS USED
FOR
Teri-EM 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.
Teri-EM 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.
Teri-EM 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 Teri-
EM generally find they will have
fewer relapses.
Your doctor, however, may have
prescribed Teri-EM for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is only available with
a doctor's prescription.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE TERI-EM IF YOU:
_ _
•
have any diseases which reduce
your body's natural defences
•
have any diseases of th

उत्पाद विशेषताएं

1 AUSTRALIAN PRODUCT INFORMATION – TERI-EM (TERIFLUNOMIDE)
1
NAME OF THE MEDICINE
Teriflunomide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Teriflunomide is formulated as film-coated tablets for oral
administration. Each tablet contains 14 mg
of Teriflunomide
Excipients with known effect: Each tablet contains 76 mg of lactose
monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Teri-EM is a light blue coloured, round, biconvex, film coated tablet,
debossed with 'HP' on one side
and '555' on other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
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.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The recommended dose of Teri-EM is 14 mg orally once daily. Teri-EM
can be taken with or without
food.
SPECIAL POPULATIONS
_CHILDREN _
The safety and efficacy of Teri-EM in paediatric patients with MS
below the age of 18 years has not
yet been established.
_ELDERLY _
Clinical studies of Teri-EM did not include patients over 65 years
old. Teri-EM 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 Section 4.4 Special
warnings and precautions for use).
_ _
2
_RENAL IMPAIRMENT _
No dosage adjustment is necessary for patients with severe renal
impairment (see Section 4.4 Special
warnings and precautions for use – Renal impairment).
_SWITCHING PATIENTS FROM OR TO OTHER DISEASE MODIFYING THERAPIES _
For recommendations related to switching patients from other disease
modifying therapies to Teri-
EM (see Section 4.4 Special warnings and precautions for use -
Switching to or from Teri-EM and
Plasma Monitoring).
4.3
C
ONTRAINDICATIONS
Teriflunomide must not be given to:
-
patients with hyper