STEGLATRO 15 ertugliflozin 15 mg film-coated tablet blister pack

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Aktív összetevők:

ertugliflozin pyroglutamic acid, Quantity: 19.43 mg (Equivalent: ertugliflozin, Qty 15 mg)

Beszerezhető a:

Merck Sharp & Dohme (Australia) Pty Ltd

Gyógyszerészeti forma:

Tablet, film coated

Összetétel:

Excipient Ingredients: sodium starch glycollate type A; magnesium stearate; microcrystalline cellulose; lactose monohydrate; titanium dioxide; hypromellose; triacetin; iron oxide red; macrogol 3350

Az alkalmazás módja:

Oral

db csomag:

7, 28

Recept típusa:

(S4) Prescription Only Medicine

Terápiás javallatok:

STEGLATRO (ertugliflozin) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as:- - monotherapy when metformin is considered inappropriate due to intolerance; or - in combination with other anti-hyperglycaemic agents,[see 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials and 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE for available data on different add-on combination therapies].

Termék összefoglaló:

Visual Identification: Red, triangular-shaped, film-coated tablets debossed with '702' on one side and plain on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Engedélyezési státusz:

Registered

Engedély dátuma:

2018-05-17

Betegtájékoztató

STEGLATRO
®
S
T
E
G
L
A
T
R
O
®
CONSUMER MEDICINE INFORMATION (CMI)
The full CMI on the next page has more details. If you are worried
about taking this medicine, speak to your doctor or pharmacist.
▼
This medicine is new or being taken differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I TAKING STEGLATRO?
STEGLATRO contains the active ingredient ertugliflozin. STEGLATRO can
be used to lower your blood sugar (glucose) alone or in
combination with certain other medicines, along with a recommended
diet and exercise program.
For more information, see Section 1. Why am I taking STEGLATRO? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE STEGLATRO?
Do not use if you have ever had an allergic reaction to ertugliflozin
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 take
STEGLATRO? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with STEGLATRO 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 TAKE STEGLATRO?
•
Take one tablet once a day.
More instructions can be found in Section 4. How do I take STEGLATRO?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING STEGLATRO?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are taking
STEGLATRO.
THINGS YOU
SHOULD NOT DO
•
Do not stop taking this medicine suddenly unless your doctor tells
you.
DRIVING
OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how STEGLATRO affects you.
LOOKING AFTER
YOUR MEDICINE
•
Keep STEGLATRO in its original packaging in a cool dry place where the
temperature stays below 30°C.
For more information, see Section 5. What should I know while taking
STEGLATRO? in the full CMI.
6.
ARE

Termékjellemzők

Page 1 of 35
▼
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 https://www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION - STEGLATRO
®
(ERTUGLIFLOZIN)
1
NAME OF THE MEDICINE
Ertugliflozin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ertugliflozin tablets contain ertugliflozin pyroglutamic acid, the
isolated form of the active
ingredient ertugliflozin. Ertugliflozin tablets contain 6.48 or 19.43
mg of ertugliflozin
pyroglutamic acid, which is equivalent to 5 and 15 mg of the active
ingredient ertugliflozin.
Excipients with known effect: Lactose monohydrate.
For the full list of excipients see Section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
STEGLATRO 5 mg are pink, triangular-shaped, film-coated tablets
debossed with “701” on
one side and plain on the other side.
STEGLATRO 15 mg are red, triangular-shaped, film-coated tablets
debossed with “702” on
one side and plain on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
STEGLATRO (ertugliflozin) is indicated as an adjunct to diet and
exercise to improve
glycaemic control in adults with type 2 diabetes mellitus as:
•
monotherapy when metformin is considered inappropriate due to
intolerance; or
•
in
combination
with
other
anti-hyperglycaemic
agents
[see
5.1
PHARMACODYNAMIC
PROPERTIES,
Clinical
trials
and
4.4
SPECIAL
WARNINGS AND PRECAUTIONS
FOR USE for available data on different add-on
combination therapies].
Page 2 of 35
4.2
DOSE AND METHOD OF ADMINISTRATION
GENERAL
The recommended starting dose of STEGLATRO is 5 mg once daily, taken
in the morning,
with or without food. In patients tolerating STEGLATRO 5 mg once daily
the dose may be
increased to 15 mg once daily if additional glycaemic control is
needed.
RENAL IMPAIRMENT
Assessment of renal function is recommended prior to initiation of
STEGLATRO and
periodically thereafter [see 4.4 SPECIAL WARNINGS A