LYXUMIA SOLUTION FOR INJECTION IN PRE-FILLED PEN 20MCG (100mcgmL)

国: シンガポール

言語: 英語

ソース: HSA (Health Sciences Authority)

有効成分:

Lixisenatide

から入手可能:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATCコード:

A10BX10

投薬量:

100mcg/mL

医薬品形態:

INJECTION, SOLUTION

構図:

Lixisenatide 100mcg/mL

投与経路:

SUBCUTANEOUS

処方タイプ:

Prescription Only

製:

Sanofi-Aventis Deutschland GmbH

認証ステータス:

ACTIVE

承認日:

2014-10-30

情報リーフレット

1 

1.  NAME OF THE MEDICINAL PRODUCT 
Lyxumia 20 micrograms solution for injection 

2.  QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each dose (0.2 ml) contains 20 micrograms (mcg) of lixisenatide (100 mcg per ml). 
Excipient(s) with known effects: 
Each dose contains 54 micrograms of metacresol. For the full list of excipients, see section 6.1. 

3.  PHARMACEUTICAL FORM 
Solution for injection (injection). 
Clear, colourless solution. 

4.  CLINICAL PARTICULARS 

4.1  THERAPEUTIC INDICATIONS 
Lyxumia  is  indicated  for  the  treatment  of  adults  with  type  2  diabetes  mellitus  to  achieve  glycaemic  control  in 
combination with  metformin, sulphon ylurea, or a basal insulin, metformin
and sulphonylurea, and basal insulin 
and
metformin when these, together  with  diet  and exercise,  do  not  provide  adequate  glycaemic  control. 

4.2  POSOLOGY AND METHOD OF ADMINISTRATION 
Posology 
Starting dose: dosing is initiated at 10 mcg Lyxumia once daily for 14 days. 
Maintenance dose: a fixed maintenance dose of 20 mcg Lyxumia once daily is started on Day 15. 
Lyxumia 10 micrograms solution for injection is available for the starting dose. 

Lyxumia is administered once daily, within the hour prior to any meal of the
day.  It is preferable that the prandial 
injection of Lyxumia is performed
before the same meal every day, when the most convenient meal has been
chosen. If a 
dose of Lyxumia is missed, it should be injected within the hour prior to the next meal. 

When Lyxumia is added to existing metformin therapy, the current metformin dose can be continued unchanged. 
When  Lyxumia  is  added  to  existing  therapy  of  a  sulphonylurea or  a  basal  insulin,  a  reduction  in  the  dose�

製品の特徴

1
1. NAME OF THE
MEDICINAL
PRODUCT
Lyxumia 20
micrograms
solution for injection
2.
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
Each dose (0.2 ml) contains 20
micrograms
(mcg) of lixisenatide (100 mcg per ml).
Excipient(s)
with known effects:
Each dose contains 540 micrograms of metacresol. For the full list of
excipients,
see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear, colourless solution.
4.
CLINICAL
PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
Lyxumia is indicated for the treatment of adults with type 2 diabetes
mellitus to achieve glycaemic control in
combination with metformin, sulphonylurea, or a basal insulin,
metformin and sulphonylurea, and basal insulin
and metformin when these, together with diet and exercise, do not
provide adequate glycaemic control.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Starting dose: dosing is initiated at 10 mcg Lyxumia once daily for 14
days.
Maintenance
dose: a fixed
maintenance
dose of 20 mcg Lyxumia once daily is started on Day 15.
Lyxumia 10 micrograms solution for injection is available for the
starting dose.
Lyxumia is administered once daily, within the hour prior to any meal
of the day. It is preferable that the prandial
injection of Lyxumia is performed before the same meal every day, when
the most convenient meal has been chosen. If a
dose of Lyxumia is missed, it should be injected within the hour prior
to the next meal.
When Lyxumia is added to existing metformin therapy, the current
metformin dose can be continued unchanged.
When Lyxumia is added to existing therapy of a sulphonylurea or a
basal insulin, a reduction in the dose of the
sulphonylurea or the basal insulin may be considered to reduce the
risk of hypoglycaemia. Lyxumia should not be
given in
combination
with basal insulin and a
sulphonylurea
due to increased risk of
hypoglycaemia
(see section 4.4).
The use of Lyxumia does not require specific blood glucose monitoring.
However, when used in combination with a
sulphonylurea or a basal insulin, blood glucose monitorin
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