LYXUMIA SOLUTION FOR INJECTION IN PRE-FILLED PEN 10MCG AND 20MCG (50mcgmL and 100mcgmL)

Pays: Singapour

Langue: anglais

Source: HSA (Health Sciences Authority)

Ingrédients actifs:

(10mcg) Lixisenatide; (20mcg) Lixisenatide

Disponible depuis:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Code ATC:

A10BX10

Dosage:

0.05mg/mL

forme pharmaceutique:

INJECTION, SOLUTION

Composition:

(10mcg) Lixisenatide 0.05mg/mL; (20mcg) Lixisenatide 0.1mg/mL

Mode d'administration:

SUBCUTANEOUS

Type d'ordonnance:

Prescription Only

Fabriqué par:

Sanofi-Aventis Deutschland GmbH

Statut de autorisation:

ACTIVE

Date de l'autorisation:

2014-10-30

Notice patient

1 

1.  NAME OF THE MEDICINAL PRODUCT 
Treatment initiation pack 
Lyxumia 10 micrograms solution for injection 
Lyxumia 20 micrograms solution for injection 

2.  QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each dose (0.2 ml) contains 10 micrograms (mcg) of lixisenatide (50 mcg per ml). 
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 ylu rea,  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 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 

Résumé des caractéristiques du produit

1
1. NAME OF THE
MEDICINAL
PRODUCT
Treatment initiation pack
Lyxumia 10 micrograms solution for injection
Lyxumia 20 micrograms solution for injection
2.
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
Each dose (0.2 ml) contains 10 micrograms (mcg) of lixisenatide (50
mcg per ml).
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 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
combina