Steglatro 5mg Film-Coated Tablets

国家: 马来西亚

语言: 英文

来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

有效成分:

Ertugliflozin L-pyroglutamic acid

可用日期:

MERCK SHARP & DOHME (MALAYSIA) SDN BHD

INN（国际名称）:

Ertugliflozin L-pyroglutamic acid

每包单位数:

7 Tablets; 28 Tablets

厂商:

Pfizer Manufacturing Deutschland GmbH.

资料单张

STEGLATRO
® FILM-COATED TABLET
Ertugliflozin (5mg, 15mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What STEGLATRO is used for
2.
How STEGLATRO works
3.
Before you use STEGLATRO
4.
How to use STEGLATRO
5.
While you are using STEGLATRO
6.
Side effects
7.
Storage and Disposal of
STEGLATRO
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT STEGLATRO IS USED FOR
•
STEGLATRO lowers blood sugar
levels in adult patients (aged 18
years and older) with type 2
diabetes.
•
STEGLATRO can be used alone or
with some other medicines that
lower blood sugar.
•
You need to keep following your
food and exercise plan while taking
STEGLATRO.
HOW STEGLATRO WORKS
STEGLATRO contains the active
substance ertugliflozin.
STEGLATRO is a member of a group of
medicines called sodium glucose co-
transporter-2 (SGLT2) inhibitors.
Ertugliflozin works by blocking the
SGLT2 protein in your kidneys. This
causes blood sugar to be removed in your
urine.
WHAT IS TYPE 2 DIABETES?
Type 2 diabetes is a condition in which
your body does not make enough insulin
or the insulin that your body produces
does not work as well as it should. Your
body can also make too much sugar.
When this happens, sugar (glucose)
builds up in the blood. This can lead to
serious medical problems like heart
disease, kidney disease, blindness and
poor circulation.
BEFORE YOU USE STEGLATRO
_ _
_WHEN YOU MUST NOT USE IT _
Do not take STEGLATRO:
•
if you are allergic to ertugliflozin or
any of the other ingredients of this
medicine (listed in
PRODUCT
DESCRIPTION
).
_ _
_BEFORE YOU START TO USE IT _
Talk to your doctor, pharmacist, or nurse
before and while taking STEGLATRO if
you:
•
have kidney problems.
•
have or have had yeast infections of
the vagina or penis.
•
have ever had serious heart disease
or if you have had a stroke.
•
have type 1 diabetes. STEGLATRO
should not be used to treat this
condition.
•
take other diabetes medicines; you
are more likely to get lo

产品特点

LPC -MK8835 -T-102018
1. NAME OF THE MEDICINAL PRODUCT
Steglatro 5 mg film -coated tablets
Steglatro 15 mg film -coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Steglatro 5 mg film -coated tablets
Each tablet contains 5 mg ertugliflozin (as ertugliflozin L -pyroglutamic acid).
Excipient(s) with known effect
Each tablet contains 28 mg of lactose (as monohydrate).
Steglatro 15 mg film -coated tablets
Each tablet contains 15 mg ertugliflozin (as ertugliflozin L -pyroglutamic acid).
Excipient(s) with known effect
Each tablet contains 85 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film -coated tablet (tablet).
Steglatro 5 mg film -coated tablets
Pink, 6.4 x 6.6 mm, triangular -shaped, film -coated tablets debossed with “701” on one side and plain
on the other side.
Steglatro 15 mg film -coated tablets
Red, 9.0 x 9.4 mm, triangular -shaped, film -coated tablets debossed with “70 2” on one side and plain
on the other side.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Steglatro is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to
diet and exercise to improve glycaemic control:
• as monotherapy in patients for whom the use of metformin is considered inappropriate due to
intolerance or contraindications.
• in addition to other medicinal products for the treatment of diabetes.
(For study results with respect to combinations and effects on glycaemic control see sections 4.4, 4.5,
and 5.1.)
4.2 Posology and method of administration
Posology
The recommended starting dose of ertugliflozin is 5 mg once daily. In patients tolerating ertugliflozin
5 mg once daily, the dose can be increased to 15 mg once daily if additional glycaemic control is