Jardiance

Ülke: Yeni Zelanda

Dil: İngilizce

Kaynak: Medsafe (Medicines Safety Authority)

Aktif bileşen:

Empagliflozin 25mg;  ;  

Mevcut itibaren:

Boehringer Ingelheim (NZ) Ltd

INN (International Adı):

Empagliflozin 25 mg

Doz:

25 mg

Farmasötik formu:

Film coated tablet

Kompozisyon:

Active: Empagliflozin 25mg     Excipient: Colloidal silicon dioxide Croscarmellose sodium Hyprolose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry yellow 02B38190

Reçete türü:

Prescription

Tarafından üretildi:

Boehringer Ingelheim Bidachem SpA

Terapötik endikasyonlar:

Type 2 diabetes mellitus Glycaemic control: JARDIANCE is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults and children aged 10 years and above as: Monotherapy - When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance. Add-on combination therapy - In combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see Further information in section 5.1).

Ürün özeti:

Package - Contents - Shelf Life: Blister pack, PVC/Al - 10 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Blister pack, PVC/Al - 30 tablets - 36 months from date of manufacture stored at or below 30°C protect from light

Yetkilendirme tarihi:

2014-06-27

Bilgilendirme broşürü

JARDIANCE NZ CMI V06
1
JARDIANCE
®
_FILM-COATED TABLETS _
_empagliflozin _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Jardiance.
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 Jardiance
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
This leaflet was last updated on the
date at the end of this leaflet. More
recent information may be available.
The latest Consumer Medicine
Information is available from your
pharmacist, doctor, or from
www.medsafe.govt.nz/
Consumers/cmi/CMIForm.asp (New
Zealand) and may contain important
information about the medicine and
its use of which you should be aware.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT JARDIANCE IS
USED FOR
Jardiance is used to lower blood
sugar levels in adults and children
aged 10 years and older with type 2
diabetes mellitus.
_TYPE 2 DIABETES MELLITUS _
It may be used when diet plus
exercise do not provide adequate
blood sugar level control either:
•
alone as a single medicine, or
•
in combination with certain other
anti-diabetic medicines such as:
•
metformin, or
•
sulfonylurea medicines such
as glimepiride and
glibenclamide, or
•
pioglitazone, or
•
insulin, or
•
dipeptidyl peptidase-4
inhibitor medicines such as
linagliptin.
In adult patients with type 2 diabetes
mellitus and cardiovascular disease,
Jardiance can be used to reduce your
risk of dying from your
cardiovascular disease.
Type 2 diabetes mellitus is also
called non-insulin-dependent
diabetes mellitus or NIDDM. Type 2
diabetes develops if the body does
not make enough insulin, or if the
insulin that your body makes does
not work as well as it should.
Insulin is a substance which helps to
lower the level of sugar in your
blood, especially after meals.
Wh

Ürün özellikleri

JARDIANCE NZ DS v11
1
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
JARDIANCE 10 mg film coated tablets
JARDIANCE 25 mg film coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
JARDIANCE 10 mg film coated tablets
Each film coated tablet contains 10 mg empagliflozin.
Excipient with known effect
Each tablet contains lactose monohydrate equivalent to 154.3 mg
lactose anhydrous.
JARDIANCE 25 mg film coated tablets
Each film coated tablet contains 25 mg empagliflozin.
Excipient with known effect
Each tablet contains lactose monohydrate equivalent to 107.4 mg
lactose anhydrous.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film coated tablet (tablet).
JARDIANCE 10 mg film-coated tablets
Pale yellow, round, biconvex and bevel-edged tablets. One side is
debossed with the code
‘S10’, the other side is debossed with the Boehringer Ingelheim
company symbol.
JARDIANCE 25 mg film-coated tablets
Pale yellow, oval, biconvex tablets. One side is debossed with the
code ‘S25’, the other side
is debossed with the Boehringer Ingelheim company symbol.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
TYPE 2 DIABETES MELLITUS
Glycaemic control:
JARDIANCE is indicated in the treatment of type 2 diabetes mellitus to
improve glycaemic
control in adults and children aged 10 years and above as:
_Monotherapy _
When diet and exercise alone do not provide adequate glycaemic control
in patients for whom
use of metformin is considered inappropriate due to intolerance.
_Add-on combination therapy _
In combination with other glucose–lowering medicinal products
including insulin, when these,
together with diet and exercise, do not provide adequate glycaemic
control (see Further
Information section 5.1).
JARDIANCE NZ DS v11
2
Prevention of cardiovascular events:
JARDIANCE is indicated in adult patients with type 2 diabetes mellitus
and established
cardiovascular disease to reduce the risk of cardiovascular death (see
section 5.1).
To prevent cardiovascular deaths, JARDIANCE should be used in
conjunction with