LANTUS SOLOSTAR 100IUML SOLUTION FOR INJECTION IN A PRE-FILLED PEN

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Insulin Glargine

Available from:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (International Name):

Insulin Glargine

Units in package:

5Units Units

Manufactured by:

Sanofi-Aventis Deutschland GmbH

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
_ _
LANTUS SOLOSTAR
SOLUTION FOR INJECTION IN PRE-FILLED PEN
Insulin glargine (100 units/ml)
_ _
WHAT IS IN THIS LEAFLET
1.
What is Lantus used for
2.
How Lantus works
3.
Before you use Lantus
4.
How to use Lantus
5.
While you are using Lantus
6.
Side effects
7.
Storage and disposal of Lantus
8.
Product description
9.
Manufacturer and Product
registration holder
10.
Date of revision
1. WHAT IS LANTUS USED FOR
Lantus is used to treat diabetes mellitus
in adults, adolescents and children age 2
years and above.
Diabetes
mellitus
is
a
disease where
your
body
does
not
produce
enough
insulin
to control
the level of blood
sugar.
2. HOW LANTUS WORKS
Lantus contains insulin glargine. This is
a
modified
insulin,
very
similar
to
human insulin. Insulin glargine has a
long and steady blood-sugar-lowering
action.
3. BEFORE YOU USE LANTUS
_- When you must not take it _
If you are allergic (hypersensitive) to
insulin glargine or to any of the other
ingredients of Lantus (for a full list of
ingredients, see
_Ingredients_
).
_- Before you start to take it _
TAKE SPECIAL CARE WITH LANTUS
Follow
closely
the
instructions
for
dosage,
monitoring
(blood
and
urine
tests),
diet
and
physical
activity
(physical work and exercise), injection
technique as discussed with your doctor.
If
your
blood
sugar
is
too
low
(hypoglycaemia), follow the guidance
for
hypoglycaemia
(see
HYPERGLYCAEMIA
AND
HYPOGLYCAEMIA at the end of this
leaflet).
Skin changes at the injection site
The injection site should be rotated to
prevent
skin
changes
such
as
lumps
under the skin. The insulin may not
work very well if you inject into a lumpy
area (see How to use Lantus). Contact
your doctor if you are currently injecting
into
a
lumpy
area
before
you
start
injecting in a different area. Your doctor
may tell you to check your blood sugar
more closely, and to adjust your insulin
or your other antidiabetic medications
dose.
Travel
Before travelling consult your doctor.
You may need to talk about
- the availability of y

Summary of Product characteristics

1
MY/LAN SOLO/1220/CCDS V20
LANTUS SOLOSTAR PACKAGE INSERT
1.
NAME OF THE MEDICINAL PRODUCT
Lantus SoloStar 100 units/ml solution for injection in a pre-filled
pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 100 units insulin glargine* (equivalent to 3.64 mg).
Each pen contains 3 ml of solution
for injection, equivalent to 300 units.
*Insulin glargine is produced by recombinant DNA technology in
_Escherichia coli_
.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection. Clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of diabetes mellitus in adults, adolescents and children
aged 2 years and above.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Lantus contains insulin glargine, an insulin analogue, and has a
prolonged duration of action. Lantus should
be administered once daily at any time but at the same time each day.
The dose regimen (dose and timing) should be individually adjusted. In
patients with type 2 diabetes
mellitus, Lantus can also be given together with orally active
antidiabetic medicinal products. The potency
of this medicinal product is stated in units. These units are
exclusive to Lantus and are not the same as IU
or the units used to express the potency of other insulin analogues
(see section 5.1).
Special population
_Elderly population (≥65 years old)_
In the elderly, progressive deterioration of renal function may lead
to a steady decrease in insulin
requirements.
_Renal impairment_
In patients with renal impairment, insulin requirements may be
diminished due to reduced insulin
metabolism.
_Hepatic impairment_
In patients with hepatic impairment, insulin requirements may be
diminished due to reduced capacity for
gluconeogenesis and reduced insulin metabolism.
_Paediatric population _

Adolescents and children aged 2 years and older patients
Safety and efficacy of Lantus have been established in adolescents and
children aged 2 years and older (see
section 5.1). The dose regimen (dose and