Lyxumia

Land: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Lixisenatide 0.05 mg/mL

Fáanlegur frá:

sanofi-aventis new zealand limited

INN (Alþjóðlegt nafn):

Lixisenatide 0.05 mg/mL

Skammtar:

0.05 mg/mL

Lyfjaform:

Solution for injection

Samsetning:

Active: Lixisenatide 0.05 mg/mL Excipient: Glycerol Hydrochloric acid Metacresol Methionine Sodium acetate Sodium hydroxide Water for injection

Gerð lyfseðils:

Prescription

Framleitt af:

Sanofi-Aventis Deutschland GmbH

Ábendingar:

Lyxumia is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with metformin, metformin and sulphonylurea, basal insulin and metformin, basal insulin and sulphonylurea when these, together with diet and exercise, do not provide adequate glycaemic control (see sections Clinical Trials and Precautions) (Risk of Hypoglycemia) for available data on the different combinations.

Vörulýsing:

Package - Contents - Shelf Life: Cartridge, glass, flanged cap with inserted laminated sealing disk and plunger stopper inside injection pen - 14 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze). After first use: store below 30°C for 14 days. After use, replace cap on pen to protect from light

Leyfisdagur:

2013-06-04

Upplýsingar fylgiseðill

Property of the sanofi-aventis group
Page 1
LYXUMIA
®
_lixisenatide _
CONSUMER MEDICINE
INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Lyxumia.
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 Lyxumia
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT LYXUMIA IS
USED FOR
Lyxumia contains the active
substance lixisenatide.
Lyxumia is a medicine used to
control the blood sugar level when
it is too high in adult patients with
type 2 diabetes mellitus
.
Lyxumia is used with other
antidiabetic medicines for diabetes
when they are not enough to control
your blood sugar levels. Your
doctor will prescribe the best
combination to manage your type 2
diabetes mellitus.
It is also important to control your
diet and exercise while using
Lyxumia.
CHECK WITH YOUR DOCTOR OR
HEALTHCARE PROFESSIONAL IF YOU ARE
NOT SURE WHETHER YOUR ANTIDIABETIC
MEDICINES CONTAIN A SULFONYLUREA OR
BASAL INSULIN.
Diabetes mellitus is a condition in
which your pancreas does not produce
enough insulin to control your blood
sugar (glucose) level. Lyxumia helps
to control your blood sugar levels only
when it is too high.
Lyxumia is not a substitute for insulin
in patients who require insulin
treatments for their diabetes. In some
cases it may be used as well as insulin.
Your doctor, however, may have
prescribed Lyxumia for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is only available with a
doctor's prescription.
BEFORE YOU USE
LYXUMIA
WHEN YOU MUST NOT USE IT
DO NOT USE LYXUMIA IF :
•
you have type 1 diabetes or
diabetic ketoacidosis (often caused by
very high blood glucose levels).
•
you are allergic to lixisenatide or
meta-cre

Vara einkenni

New Zealand Data Sheet
June 2017
Lyxumia Injection, solution
lyxumia-ccdsv5-dsv3-09jun17
Page 1
DATA SHEET
1
LYXUMIA INJECTION, SOLUTION
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
LYXUMIA 10ΜG SOLUTION FOR INJECTION (GREEN INJECTION PEN)
Each dose (0.2 mL) contains 10 μg of lixisenatide (0.05 mg/ ml).
LYXUMIA 20ΜG SOLUTION FOR INJECTION (PURPLE INJECTION PEN)
Each dose (0.2 mL) contains 20 μg of lixisenatide (0.1 mg/mL).
LYXUMIA TREATMENT INITIATION PACK (1 GREEN + 1 PURPLE INJECTION PEN)
Each dose (0.2 mL) from the 10 μg pen contains 10 μg of lixisenatide
(0.05 mg/mL). Each dose
(0.2 mL) from the 20 μg pen contains 20 μg of lixisenatide (0.1
mg/mL).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Lixisenatide is an amorphous, hygroscopic, white to off-white powder.
Lyxumia solution is a 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, metformin and
sulphonylurea, basal insulin
and metformin, basal insulin and sulphonylurea when these, together
with diet and exercise, do
not provide adequate glycaemic control (see sections CLINICAL TRIALS
and PRECAUTIONS
(Risk of Hypoglycemia)) for available data on the different
combinations.
New Zealand Data Sheet
June 2017
Lyxumia Injection, solution
lyxumia-ccdsv5-dsv3-09jun17
Page 2
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
The starting dose is 10 mcg (µg) Lyxumia once daily for 14 days.
Then, the Lyxumia dose should be increased to 20 mcg (µg) once daily,
which is the maintenance
dose.
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 a combination of a basal insulin and a
sulphonylurea, a reduction in
the dose of the basal insulin or the sulphonylurea may be considered
according to individual
respon