Lyxumia 20micrograms0.2ml solution for injection 3ml pre-filled pen

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Lixisenatide

Available from:

Sanofi

ATC code:

A10BJ03

INN (International Name):

Lixisenatide

Dosage:

100microgram/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Subcutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06010203; GTIN: 5000283655831

Patient Information leaflet

Legende / Legend
SAP-Nr. / Plant PM code:
538580
Sprachvariante / Country code:
103
Version:
2
Datum / Date:
13.09.2017 Sid.
Abmessungen / Dimensions:
296 × 420 mm
Schriftgröße / Font size:
9,5 Pt
Zeilenabstand / Line spacing:
10,5 Pt
Seite / Page:
1/1
Druckbare Farben / Printing colours
Pantone Black
Technische Information / Technical information
Kontur / Outline
PACKAGE LEAFLET:
INFORMATION FOR THE USER
LYXUMIA® 10
MICROGRAMS
SOLUTION FOR INJECTION
LYXUMIA® 20
MICROGRAMS
SOLUTION FOR INJECTION
lixisenatide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START USING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
– Keep this leaflet. You may need to read it
again.
– If you have any further questions, ask your
doctor, pharmacist or nurse.
– This medicine has been prescribed for you
only. Do not pass it on to others. It may
harm them, even if their signs of illness
are the same as yours.
– If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. See section 4.
IMPORTANT INFORMATION ABOUT SOME OF THE
INGREDIENTS OF LYXUMIA
This medicine contains less than
1 mmol sodium (23 mg) per dose, i.e.
essentially “sodium-free”.
This medicine contains metacresol which may
cause allergic reactions.
3. HOW TO USE LYXUMIA
Always use this medicine exactly as your doctor,
pharmacist or nurse has told you. Check with
your doctor, pharmacist or nurse if you are not
sure.
HOW MUCH TO INJECT
• The starting dose is 10 micrograms once a
day for the first 14 days – injected using
the GREEN pen.
• The dose from then onwards will be
20 micrograms once a day – using the
PURPLE pen.
WHEN TO INJECT
Inject Lyxumia in the hour before any meal of
the day. Preferably inject Lyxumia before the
same meal every day, when you have chosen
the most convenient meal for your injection.
WHERE TO INJECT
Inject Lyxumia into the skin (subcutaneously) of
your stomach area (abdomen), upper leg (thigh)
or upper arm.
LEARNING HOW TO USE THE P

Summary of Product characteristics

OBJECT 1
LYXUMIA 20 MICROGRAMS SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 25-Sep-2017 | SANOFI
1. Name of the medicinal product
Lyxumia 10 micrograms solution for injection
Lyxumia 20 micrograms solution for injection
2. Qualitative and quantitative composition
Lyxumia 10 micrograms solution for injection
Each dose (0.2 ml) contains 10 micrograms (mcg) of lixisenatide (50
mcg per ml).
Lyxumia 20 micrograms solution for injection
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 oral glucose-lowering medicinal products
and/or basal insulin when these,
together, with diet and exercise, do not provide adequate glycaemic
control (see sections 4.4 and 5.1 for
available data on the different combinations).
4.2 Posology and method of administration
Posology
Starting dose: dosing is initiated at 10 mcg lixisenatide once daily
for 14 days.
Maintenance dose: a fixed maintenance dose of 20 mcg lixisenatide once
daily is started on Day 15.
For the starting dose Lyxumia 10 micrograms solution for injection is
available.
For the maintenance dose Lyxumia 20 micrograms solution for injection
is available.
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 sp